clinical research associate ppd

THE CORE COMPETENCY FRAMEWORK

The PPD CRA Competency Framework is the standard of competency expectations with regards to the technical knowledge, skills, and abilities required for all CRAs to thrive at PPD.

Whether you’re just starting out or are a seasoned clinical research associate, all four competencies apply to your career. Each is vital to your career progression and will help you to identify any gaps in your skills as well as competencies you may need to build upon to advance, both now and in the future.

While acquiring these competencies may help you build a satisfying career, they do not constitute a checklist for promotion within PPD. Only you can determine how to define your personal idea of success. It is important to maintain an ongoing dialogue with your manager to communicate where you are in your development journey.

In addition to these technical competencies, you will also need to focus on gaining a well-rounded set of skills and experiences that exemplify our 4i Values and demonstrate successful performance against the key role performance and quality metrics.

TECHNICAL ABILITY

Study and site management, clinical trial knowledge, quality and risk management.

Sub-competencies

• System Knowledge
• Systems Management
• Data Administration
• Data and Metrics Analysis
• Site Oversight
• Monitoring Management
• Clinical Trial Framework
• Monitoring Proficiency
• Risk & Issue Management
• Ethical Considerations and Subject Safety

SUB-COMPETENCIES

Acra proficiencies.

Operating Systems

• Understand on a basic level and use common, necessary operating systems to complete daily tasks (e.g., email, spreadsheets, presentations).

Technical Issues Management

• Adjust to connectivity:
• Be aware of the wireless strength signal.
• Know about Wi-Fi signal issues (areas that are spotty).
• Know how to connect the laptop to a Wi-Fi source”

Clinical Systems

• When joining a study team, ensure knowledge of all systems (including PPD and/or other vendors) in use, including but not limited to IXRS, EDC, eTMF, CTMS, etc.

Adoption and Application

• Demonstrate a willingness to learn and adapt to new systems and technology.

Remote or Onsite Track Specific Proficiencies

Cra i proficiencies.

• Determine IT issues and escalate to resolution through appropriate channels.
• be aware of the wireless strength signal.
• know about Wi-Fi signal issues (areas that are spotty).
• know how to connect the laptop to a Wi-Fi source
• Raise queries, review data currency, track monitoring activities, and report on progress of completion with some support.

CRA II PROFICIENCIES In addition to all previous CRA level proficiencies:

• Fully understand and use common, necessary operating systems for the completion of daily tasks (e.g., email, spreadsheets, presentations).
• Act as a specific program expert for others who may need assistance.
• Determine IT issues and escalate when necessary through appropriate channels.
• Practice troubleshooting methods for minor issues (reboot, alternate browser use) to attempt to resolve prior to escalation.
• When joining a study team train, independently onboard all systems (including PPD and/or other vendors) being utilized with minimal oversight, including but not limited to IXRS, EDC, eTMF, LMS, CTMS, etc.
• Raise queries, review data currency, track monitoring activities, and report on progress of completion.
• Pro-actively seek to extend basic knowledge by learning new systems, processes, and regulations.
• Seek support from more experienced colleagues to enhance knowledge.
• Quickly learn and adapt to new systems and technology.
• Reach out for additional assistance and training when needed.

SENIOR CRA I PROFICIENCIES In addition to all previous CRA level proficiencies:

• Use systems to develop new solutions for organization and completion of daily tasks.
• Effectively use a variety of relevant operating programs/systems.
• Make presentations for training/study updates by using all available resources/systems.
• Be open to new systems/technology and remain up to date on current technology/systems.
• Engage troubleshooting methods for minor issues to attempt to resolve prior to escalation.
• Take responsibility for followup of IT issues to quick resolution.
• When joining a study team, independently train others on all systems (including PPD and/or other vendors) being utilized, including but not limited to IXRS, EDC, eTMF, LMS, CTMS, etc. Use resources proactively to identify risks and escalate appropriately.
• Act as a mentor for a specific system.
• Fully embrace and quickly learn and adapt to new systems and technology.
• Support colleagues in adapting to new systems/technology.
• Proactively reach out for assistance and additional training as needed.
• Proactively seek opportunities to learn new systems and implement new strategies to improve processes and time management.
• When joining a study team, independently train others on all systems (including PPD and/or other vendors) being utilized, encompassing but not limited to IXRS, EDC, eTMF, LMS, CTMS, and others.
• Use resources proactively to identify risks and escalate appropriately.
• Share lessons learned and best practices.
• When joining a study team, train others on all systems (including PPD and/or other vendors) being utilized, encompassing but not limited to IXRS, EDC, eTMF, LMS, CTMS, and others at direction of the Remote CRA or CTM.

SENIOR CRA II PROFICIENCIES In addition to all previous CRA level proficiencies:

• Provide training to study team or mentee on various systems for better organization and completion of daily tasks.
• Create spreadsheets using diagrams, pivot tables for group trainings to provide data status reports at project level.
• Assist others with troubleshooting efforts.
• Provide mentorship to others in clinical systems. Evaluate functions and identify efficiencies in reports. Act as SME and share positive support for the clinical team in utilizing the study systems. Proactively ensure training is current regarding new systems, volunteer for opportunities to train and present regarding new systems. Proactively seek feedback to aid in training and support.
• Routinely provide system trainings for new team member within project team.
• With overview from CTM, review/develop manuals for relevant study- specific system/programs and/or study-specific processes (e.g., support revision of an EDC manual).
• Subject matter expert in determining role application of system and best practices
• Can facilitate discussions about new systems and technology during team meetings
• Provide training to study teams or mentees on various systems for better organization and completion of daily tasks.
• Routinely provide system training for new project team members.
• Create spreadsheets using diagrams and pivot tables for group training to provide data status reports at the project level.
• Act as the SME and share positive support for the clinical team in utilizing the study systems.
• With overview from the CTM, review/develop manuals for relevant study-specific system/programs and/or study-specific processes (e.g., support revision of an EDC manual).
• Provide training to study teams or mentees on various systems for better organization and completion of daily tasks at direction of the Remote CRA or CTM.

PRINCIPAL PROFICIENCIES In addition to all previous CRA level proficiencies:

• Serve as a resource and mentor to new team members or onboarding monitors on all operating systems.
• Serve as a resource and mentor to new team members or onboarding monitors on all PPD and Vendor systems.
• Understand the business need to provide new systems and help provide others with a positive understanding of this need.
• Use previous experience to leverage the development and implementation of new processes and tech.
• Serve as a resource and mentor to new team members or onboarding monitors on all operating systems
• Serve as a resource and mentor to new team members or onboarding monitors on all PPD and vendor systems.
• Serve as a change agent when a new system is implemented.

Compliance with Electronic Record Requirements and Regulations

• Determine if all of the systems the site uses for study conduct have been previously assessed for compliance with ICH-GCP.
• Verify availablity of any related documentation.
• Escalate lack of documentation to the Remote CRA.
• Demonstrate understanding of personal privacy issues related to the collection and use of data.

Use of PPD Provided Technology

• Follow all PPD policies involving the use of company-provided technology and systems for personal use, including but not limited to any SOPs regarding use of technology, the Global Privacy Policy, and telecommunications policy.
• Act in a manner that appropriately represents PPD when using PPD technologies.

Systems Access

• Ensure that system accesses are requested/granted for relevant site staff.
• Recognize the importance of limited access.
• Request access revocation when participation in a study is finished (i.e., staff changes).
• Confirm that site systems used for study conduct are assessed for study use and compliant with ICH GCP.  Verify that system access is well controlled.  Escalate issues with compliance to study management.
• Follow all PPD policies involving the use of company-provided technology and systems for personal use, including but not limited to any SOPs regarding use of technology, the Global Privacy Policy and telecommunications policy.
• Confirm that site staff have appropriate access to the necessary study systems based on PI-assigned delegated duties.
• Understand the  importance of limited access.
• Identify and escalate issues with compliance at their sites to study management with some support.
• Ensure availability of reports to the monitoring team.
• Identify and escalate issues with compliance at their sites identified during on-site visits to the Remote CRA with support as needed.
• Identifyand escalate issues with compliance at their sites to study management.
• Understand and follow all regulations for personal privacy issues related to the collection and usage of data.
• Ensure timely maintenance of access, including all new or revoked access needs.
• Compare available reports ongoing and escalate discrepancies.
• Identify and escalate risks and gaps of accesses at a site level (e.g., lack of access to site backup personnel close to vacations period) .
• Identify and escalate issues with compliance and implement corrective actions with their sites.
• Reference policies and provide others with assistance in personal use of technology.
• Assist study team with oversight and management of study systems access through reporting reviews.
• Identify and escalate risks and access gaps at a study level.
• Assist the study team with oversight and management of study systems access through reporting reviews.
• Assist others with their understanding of the policies regarding electronic record requirements.
• Train study team on systems access maintenance process.
• Manage system access requests across study team.
• Provide oversight of systems access across study team and follow up on issues to resolution.
• Demonstrate basic knowledge of:
• The flow of different types of data throughout a clinical trial (EDC, e.g., tracking systems, etc.).
• Data sources (e.g., site, subject, vendors, internal PPD stakeholders etc.)
• Data stakeholders.
• The role Data Management and Biostatistics serve in the lifecycle of a study and how these functions affect it.
• The process of data capture and the importance of technology in data collection, capture, and management.

Data Stewardship

• Recognize the significance and importance of data quality assurance and how SOPs are used to guide those procedures.
• Demonstrate understanding of the importance data entry into appropriate systems in real time.
• Understand the importance of following tracking guidelines to ensure data consistency/stewardship.

Data Accountability and Ownership

• Take responsibility for limited data review and stewardship and demonstrate a willingness to ask questions to ensure the responsibilities are well understood and the timelines agreed upon.
• Identify data problems trends at a site level.
• Escalate to People Manager or Remote CRA any struggle to comply with expected data timelines.
• Discuss potential solutions to be implemented when data timelines/expectations cannot be met.
• Learn new methods of working, procedures, and technologies when dealing with data.

Data Gathering

• Identify relevant sources of data needed for personal metrics review and site risk review.
• Perform basic data querying across study systems and platforms.

Demonstrate knowledge of:

• the flow of different types of data throughout a clinical trial (EDC, tracking systems, etc.).
• data stakeholders.
• how/what role Data Management and Biostatistics serve in the lifecycle of a study.
• the process of data capture and the importance of technology in data collection, capture, and management.
• Understand the significance and importance of data quality assurance and how SOPs are used to guide those procedures.
• Take responsibility for data review and stewardship, asking  questions to ensure the responsibilities have been well understood and the timelines agreed upon.
• Identify data problems/risks at a site level.
• Escalate to People Manager or CTM any struggle to comply with expected data timelines .
• Be open to changes, including, but not limited to new methods of working, procedures, and technologies when dealing with data.
• Demonstrate ability to identify relevant sources of data needed for personal metrics review and site risk review.
• Communicate in an appropriate and timely manner with data management and centralized monitoring team members as needed with some support.
• Communicate in an appropriate and timely manner with vendors and others as applicable at study level with some support.
• Actively review data for stewardship completion across all sites and coordinate with local project team members as needed with some support.
• Coordinate with peers/managers on the root cause analysis and implement solutions, including corrective and preventative actions regarding data stewardship and quality risks with data review with some support.
• Organize data to review with data cleaning to avoid data errors such as handling missing and/or data inconsistencies with some support.
• Closely communicate in an appropriate and timely manner with Remote CRA.
• Understand and demonstrate ability to identify the sources of data, timing of data added to the system (inputs/outputs), functions involved in data processing, and review through to the final TLFs, CSR etc.
• Maintain data entry into appropriate systems in real time.
• Understand the data collection, data entry, and verification process.  •Recognize the importance of accurate data in alignment with established guidelines (eCRF Completion Guidelines).
• Communicate in an appropriate and timely manner with data management and centralized monitoring team members as needed.
• Take accountability for own data;  self-ensure accuracy rather than wait for management review.
• Actively review data for stewardship completion.
• Consistently maintain quality of data.
• Escalate data and/or systems issues that may impact the project and/or study quality.
• Work with peers/managers on the root cause analysis and implement solutions (corrective and preventative actions) regarding data stewardship and quality risks with data review.
• Gather data from one or more sources and platforms.
• Prepare data to review with data cleaning, such as handling missing or inconsistent data (data errors).
• Work with the Remote CRA and managers on the root-cause analysis and implement solutions (corrective and preventative actions) regarding data stewardship and quality risks with data review.
• Understand the difference between data science (analytics, testing) and data engineering (data storage, management).
• Identify non-compliance with data stewardship and assist with implementation corrective actions on their assigned teams.
• Identify data and/or systems-related concerns/issues that could represent a quality risk for the project and escalate proactively; perform a root cause analysis independently, proposing solutions with limited support from the manager.
• Gather data from various PPD and vendor systems and platforms to address current site and study needs.
• Identify non-compliance with data stewardship and assist with implementation on corrective actions with local project team members and on their assigned teams.
• Identify warning signals regarding data stewardship deterioration.
• Perform a root-cause analysis independently, proposing solutions with limited support from the Remote CRA.
• Identify non-compliance with data stewardship on their teams and follow up to resolution. Implement corrective actions.
• Support team members and assist them to ensure data deliverables are met; create a sense of accountability for data in the mentees.
• Share data review and systems/technology experience with other team members.
• Be proficient with all systems where data is stored and know how to review and export data from those systems.
• Use logical thinking to determine which system would provide the necessary data to retrieve based on current study status and needs.
• Identify non-compliance regarding data stewardship across the local project team and follow up to implement corrective action to bring about resolution.
• Identify site non-compliance regarding data stewardship across studies and follow up to implement corrective action to bring about resolution as applicable.
• Understand and evaluate the challenges and usefulness of multiple data sources and analytics.
• Fully understand the business implications of data stewardship and help demonstrate that understanding to others in a mentor capacity.
• Take actions to achieve data goals beyond what is expected. Establish procedures to monitor the data for assigned sites or projects.
• Consistently take effective actions when escalating data risks and/or issues; suggest and implement creative and effective actions.
• Act independently with data stewardship and review,  and ask for support when necessary.
• Gather data from all systems needed for not only assigned sites but also for the study team as a whole.
• Mentor and train others on where and how to retrieve necessary data.
• Establish procedures to monitor the data for assigned sites or projects.
• Gather data from all systems needed for the study team as a whole.
• Mentor and train others on where and how to retrieve necessary data and how to improve remote resolution of findings, among other tasks.
• If applicable, mentor and train others on where and how to retrieve necessary data on large projects and on how to improve remote resolution of findings, among other tasks.

Critical Data & Processes

• Perform data reconciliation using system of record and act on discrepancies that are identified as requiring follow-up.
• Communicate with the Remote CRA.
• Work with a support team to begin referencing risk-assessment documentation to anticipate and mitigate potential issues.

Data Analysis and Interpretation

• Use available systems, dashboards, data, and information that is provided for projects to complete reconciliations.
• Apply basic retrieval and filtering applications within data systems.
• Gain experience using available systems to manipulate/analyze/investigate/evaluate data to get more complex results.

Personal Performance Metrics

• Become experienced at reviewing personal performance with metrics and systems technology.
• Identify outliers, review with management during 1:1, and put in place a plan of action for improvement, as needed.
• Seek the People Manager and the Remote CRA for feedback on technology and systems knowledge to clearly understand areas for further development and work to improve.
• Build skills in technical systems and data areas to address learning deficiencies/needs.
• Become familiar with available sources of training/information.

Site Performance Metrics

• Gain knowledge of specific data metrics that relate to site performance.
• Identify outliers and review with the Remote CRA to determine a plan of action in addressing risk outliers within the site.

Critical Data & Processes

• Perform data review using system of record to identify and mitigate potential issues and risks.
• With support, begin to develop an awareness of the interrelatedness of study systems and analyze data trends to direct future monitoring actions.
• Communicate with centralized monitoring team members.
• Reference risk assessment documentation to anticipate and mitigate potential issues.
• Determine where to retrieve data from the appropriate systems in order to best review for risk.
• Use available systems, dashboards, data and information that is provided for projects to identify inconsistencies.
• Implement common retrieval and filtering applications within data systems.
• Take advantage of available systems to manipulate/analyze, investigate, evaluate data to get more complex results.
• Demonstrate ability to review personal performance  with metrics and systems technology.
• Assess for outliers.
• Review with management during 1:1 and discuss plan of action to improve, as needed.
• Proactively ask people manager feedback on technology and systems understanding to  clearly understand personal strengths and weaknesses.
• Be conscious of areas for further development in systems and technology and  work with the people manager to improve.
• Observe industry trends in technology and data review.  Become familiar with available sources of training/information.
• Demonstrate knowledge of specific data metrics that relate to site performance.
• Assess outliers for potential risk.
• Review with Study Management to determine plan of action in addressing risk outliers with the site.
• Analyze data to generate an on-site visit work order with some support.
• Continuously assess data from multiple sources including centralized monitoring to understand how the site is performing with some support, identify signals to prevent performance deterioration or identify emerging risks with some support.
• Decisions regarding when an on-site visits is needed.
• Generation of an on-site visit work order with some support.
• Understand interrelatedness of different study systems and identify proper sources of data to identify risks at site level.
• Identify and escalate issues and implement corrective action preventive plan.
• Reference risk assessment documentation to be aware of potential risk.
• Explore data for the purpose of identifying potential data problems resulting in a risk to the project or subject safety – data exploration could take the form of trends, outliers, or examining relationships between data areas.
• Efficiently use available systems and dashboards; and gather data and information to identify inconsistencies.
• Demonstrate ability to break down data into manageable parts and analyze, interpret, and summarize findings/risk.
• Set personal goals for improvement/training in data a technology areas.
• Mentor less-experienced or new PPD colleagues in basic systems and data-entry /review activities.
• Assess site metrics for outliers and potential risk factors.
• Address for root cause and manage an action plan with the site for improvement.
• Analyze data to generate an on-site visit work order with minimal support.
• Continuously assess data from multiple sources including centralized monitoring, to understand how the site is performing with minimal support, identify signals to prevent performance deterioration, or identify emerging risks with minimal support.

Outputs of analyzing data:

• Decision on when an on-site visit is needed.
• Generation of an on-site visit work order with minimal support.
• Demonstrate awareness of interrelatedness of study systems and analyze data trends for direct future monitoring actions.
• Reference risk-assessment documentation to anticipate and mitigate potential issues.
• Analyze a large amount of data on a project level, identify issues, and arrive at solutions with minimal management support.
• Prioritize data risk and trends for follow-up and resolution.
• Take advantage of available systems to manipulate/analyze/investigate/evaluate data to get a more complex result.
• Proactively attempt to achieve set goals by routinely reviewing performance metrics.
• Seek areas of development, i.e.,  participate in small projects out of scope.
• Provide training and mentor others on how to review performance metrics with new monitors.
• Perform root cause analysis, evaluate data issues, and implement corrective and preventive actions for data quality concerns on a site level.
• Put plans in place to address site data quality risks with minimal support.
• Continuously assess and analyze data from multiple sources including centralized monitoring to evaluate how the site is performing with limited support.
• Analyze data on a project level across monitoring team activitites, identify risks and issues, and arrive at solutions with minimal management support.

Outputs of analyzing data in relation to activities to be conducted on site:

• Decision regarding when an on-site visits is needed.
• Provide training and mentoring on how to review performance metrics across the monitoring team.
• Provide training and mentor others on how to review performance metrics with new on-site monitors on large projects.
• Analyze large data for trends at project level.
• Perform root cause analysis and utilize available resources to implement corrective and preventive actions.
• Independently analyze large data, identify root cause and escalate.
• Be aware of important issues around data governance and how that can impact data analysis.
• Understand the value of data collection, storage, and maintenance.
• Take action to achieve data review or systems learning goals that are beyond requirement.
• Identify patterns/trends across the study by reviewing outliers using various data reports.
• Develop risk-mitigation plans to address areas of identified data quality risk.
• Continuously assess and analyze data from multiple sources including centralized monitoring to evaluate how the site is performing independently.
• Engage with data risk management on project level.
• Establish processes to monitor data at a project level and implement corrective and preventive actions to mitigate risks.
• Identify opportunities to mentor and coach monitors, and help others assess their developmental needs with data stewardship/accountability and systems understanding.
• Identify potential areas of data quality risk and coach/train project team(s) on the development of risk mitigation plans.
• Identify opportunities to mentor and coach the monitoring team and help others assess their developmental needs relevant to data stewardship/accountability and systems understanding.
• Mentor and train other monitors on how to retrieve necessary data.
• Identify areas of risk and/or opportunity regarding established processes to monitor data.
• If applicable, mentor and coach other monitors and help others assess their developmental needs regarding data stewardship/accountability as well as systems understanding on larger projects.
• If applicable, mentor and train other monitors on large projects regarding where and how to retrieve necessary data.

PI Oversight

• This role is not intended to be site-facing; escalate detailed information to the Remote CRA if improper oversight is suspected or identified.

Roles and Responsibilities

• Assess if PI/site meet criteria for a qualification visit waiver.
• Ensure compliance with protocol, good clinical practice, and investigator engagement.
• Contribute with guidance to any risk-mitigation plans as necessary based on performance.
• Ensure all activities are closely supervised by a People Manager or a Remote CRA.

Regulatory Adherence

• Compare Electronic Protocol Inquiry Platform (ePIP) with deviations noted and escalate discrepancies.
• Discuss all protocol misconduct with the Remote CRA.
• With the support of other team members (Remote CRA , CAS), contribute to a corrective and proactive action plan to prevent recurrence.
• In the event of recurrent deviations, discuss option for sPIP with the Remote CRA and People Manager.
• Monitor sites for PI oversight, protocol and study guidelines adherence.
• Evaluate the PI’s availability to meet to discuss study progress, understanding of the study protocol, status of all subjects, applicable regulations, and ICH-GCP; and overall level of involvement in implementing compliance.
• Escalate to the CTM detailed information if lack of proper oversight is identified.
• Have all activities closely supervised by People Manager and the CTM or an experienced monitor.
• Assess PI qualification and resources.
• Verify documentation of investigator oversight and delegation.
• Throughout the trial, evaluate investigator and site staff for qualification and training, provide study-specific training and inspect facilities to confirm adequacy.
• Evaluate in detail compliance with the protocol and GCP and investigator engagement and revise, with guidance, risk mitigation plans as necessary based on performance.
• Confirm the PI or delegated staff member has performed and documented all activities.
• Regularly discuss site staff workload to detect impact on the project and/or data quality.
• Identify deviations from the protocol, SOPs, regulatory requirements during site discussions and document/source review.
• Discuss all protocol and regulatory misconduct with the site staff and PI.  •Determine resolution to ensure further deviation does not occur.
• With the support from other team member (CTM, SCRA), work on a corrective and proative action plan in order to avoid recurrence.
• Provide training/retraining, if applicable. Document it accordingly.
• In case of recurrent deviations, discuss with CTM and LM option for sPIP.
• Coordinate and oversee all aspects of the clinical-monitoring, remote-monitoring, and site-management processes with support.
• Gather information from the on- site CRA and escalate detailed information to the CTM if improper oversight is identified with support.
• With the support of other team members (CTM or experenced monitor), work on a corrective and proactive action plan in order to prevent recurrence.
• Escalate detailed information to the Remote CRA if improper oversight is identified.
• Throughout the trial during each on-site visit, evaluate the Investigator and site staff for qualification and training, provide study-specific training, and inspect facilities to confirm adequacy.
• Work with the Remote CRA on a corrective and proactive action plan to prevent recurrence.
• In the event of recurrent deviations, discuss option for sPIP with the Remote CRA and the People Manager.
• Evaluate the PI’s availability to meet to discuss study progress, understanding of the study protocol, status of all subjects, applicable regulations, and ICH-GCP and overall level of involvement in implementing compliance. Escalate to the CTM detailed information if lack of proper oversight is identified.
• Review with site the PI oversgight requirements if needed.
• Discuss all protocol and regulatory misconduct with the site staff and PI.  Determine resolution to ensure further deviation does not occur.
• Coordinate and oversee all aspects of the clinical monitoring, remote monitoring, and site-management processes with minimal support.
• Gather information from the on-site CRA and escalate detailed information to the CTM if improper oversight is identified.
• With minimal support of other team members (CTM, experienced monitor), work on a corrective and proactive action plan in order to prevent recurrence.
• Evaluate potential risks and create an action plan.
• Share with the CTM the analysis and actions.
• Evaluate potencial risk of resource and qualification problems.
• Proactively identify deviations from the protocol, SOPs, regulatory requirements during site discussions and document/source review.
• Work on a corrective and proative action plan in order to avoid recurrence with CTM support.
• Independently coordinate and oversee all aspects of the clinical monitoring and site-management processes.
• Share analysis and actions with the CTM.
• Work with the CTM on a corrective and proactive action plan, including input from the on-site CRA, in order to prevent recurrence.
• Proactively identify deviations from protocol during continual document/source review.
• Share analysis and actions with the Remote CRA.
• Work with the Remote CRA on a corrective and proactive action plan in order to prevent recurrence.
• Propose a good evaluation methodology of site compliance.
• Work on a corrective and proative action plan in order to avoid recurrence.
• Prepare a corrective and proactive action plan, including input from the on-site CRA in order to prevent recurrence, with limited CTM support.
• Propose to the CTM a solid evaluation methodology for site compliance based on available data sources, to be used for continual review in conjunction with on-site activities.
• Work with the Remote CRA on a corrective and proactive action plan in order to prevent recurrence
• Contribute to the evaluation methodology of site compliance based on activities that can only be completed on-site.
• Share with the study team the analysis / action to help them prevent the same risks / problems.
• Share ideas/tools with the study team.
• Work closely with the CTM to implement the evaluation methodology for site compliance based on available data source used for continual review in conjunction with on-site activities.
• Share with the Remote CRA (and on large studies, other on sites’ CRAs) analysis/action to help them prevent the same risks/problems.

Start-up, EC & Regulatory Submissions

• Gain an understanding of start-up strategies of study/country and sites and engage in discussions with the Remote CRA and local start-up team to learn about potential risks and challenges.
• Support document collection and provide review of patient-facing materials and translations as applicable.
• Gain experience supporting site-readiness activities utilizing available study reports, dashboard to ensure site access to the system, availabilty of study supplies, and SIV planning.
• Ensure all activities are closely supervised by a People Manager, Remote CRA, or an experienced start-up team member.

Subject Recruitment and Retention

• Ensure all activities are closely supervised by a People Manager, Remote CRA, or an experienced monitor.
• Gain an understanding of recruitment/retention strategies of study and site subjects and engage in discussions with the Remote CRA to evaluate/learn about potential recruitment risks and challenges.
• Gain experience working with site payments by utilizing available reports to ensure timely and accurate payments are made.

Conduct Remote Monitoring and Monitoring Visits

• This role is not intended to be site facing; however, there may be situations where on-site co-monitoring visits occur. In such cases:
• Use critical thinking to identify the root cause of problems and contribute to a robust CAPA plan, if applicable.
• Ensure all activities are closely supervised by a People Manager,a Remote CRA, or an experienced on-site co-monitor.

Risks, issues, and trends identification

• Develop critical-thinking skills and provide suggestions for effective corrective and preventive actions that could be implemented within the site through mentoring and coaching by People Manager, a Remote CRA, or on larger studies, an experienced monitor.
• Engages in discussions about recruitment/retention of study subjects , evaluates recruitment/retention strategy of the site, discusses potential recruitment/retention challenges and escalates risks issues associated with recruitment to the CTM.
• All activities closely supervised by People Manager and the CTM or an experienced monitor.

Conduct of Monitoring Visits

• Receives authorization to conduct remote and onsite visits independently.
• Gets well prepared to conduct remote/onsite visits.
• Assesses study protocol activities to verify trial records are accurate, complete and current.
• Evaluates compliance with the protocol, IP guidelines, GCP and investigator engagement and revises, with guidance, risk mitigation plans as necessary based on performance.
• Assess site processes and identify potential risks, applying concepts of effective training methods to manage those potential risks processes proposing actions to the site be back on track.

Risks, issues and trends identification

• Use critical thinking to identify the root cause of problems and a robust CAPA plan, if applicable. Discuss actions with CTM and LM.
• Have all  activities closely supervised by People Manager and the CTM or an experienced monitor.
• Coordinate local input into the site list development with support from a People Manager or an experienced monitor.
• Ensure all system access and study training for site staff is current utilizing study reports and dashboards.
• Review and provide TA input into patient-facing materials and Country Master ICFs with support.
• Ensure site readiness to begin enrollment; at the direction of the project team, trigger site activation with support.
• Gain authorization to conduct remote monitoring independently under close supervision by the People Manager and CTM or by an experienced monitor on larger projects.
• Provide the Remote CRA with input for the potential site list.
• Ensure the Remote CRA and project team are aware of all issues impacting site activation or recruitment and share plans for resolution.
• Use critical thinking to identify or review the site-specific patient pathway for protocol, opportunities to enhance the pool of potential subjects or tools to retain subjects; discuss actions with the Remote CRA and the LM.
• Use critical thinking to identify the root cause of problems and a robust CAPA plan, if applicable; discuss actions with the Remote CRA and the LM.
• Receive authorization to conduct on-site visits independently.
• Engage in discussions about recruitment/retention of study subjects , evaluate recruitment/retention strategy of the site, discuss potential recruitment/retention challenges and escalate risks issues associated with recruitment to the CTM.
• Receive authorization to conduct remote and onsite visits independently.
• Remain well prepared to conduct remote/onsite visits.
• Assess study protocol activities to verify trial records are accurate, complete and current.
• Evaluate compliance with the protocol, IP guidelines, GCP and investigator engagement and revise, with guidance, risk mitigation plans as necessary based on performance.
• Critically assess site processes and identify potential risks, applying concepts of effective training methods to manage those potential risks processes, proposing actions to get  the site be back on track with minor CTM support.
• Use critical thinking to identify the root cause of problems and a robust CAPA plan, if applicable.
• Openly discuss issues with site staff, activities within the CAPA and how/when it will be completed with minor CTM support.
• Coordinate local input into the site list development with minimal support from a People Manager or an experienced monitor.
• Review and provide TA input into patient-facing materials and Country Master ICFs with minimal support.
• Ensure site readiness to begin enrollment; at the direction of the project team, trigger site activation with minimal support.
• Receive authorization to conduct remote monitoring independently.
• Closely review recruitment metrics and set up specific actions for each site and/or assist the other monitors assigned to the study, with CTM support.
• Critically assess site processes and identify potential risks, applying concepts of effective training methods to manage those potential risks processes and propose actions to get the site back on track.
• Openly discuss issues with site staff, activities within the CAPA and how/when it will be completed.
• Coordinate local input into the site list development independantly.
• Communicate closely with the start-up team to review project-activation dates and set up specific actions for each site and/or assist the start-up team as required, with STM support.
• Closely review recruitment metrics and set up specific actions for each site and/or assist the other monitors assigned to the study.
• Develop an effective risk mitigation plan.
• Share ideas/tools with the study team and follow up with the team making strategy adjustments, if necessary.
• Regularly share information on site’s capabilities or organization with other monitors managing same site and follow up on results with the team.
• Develop an effective risk mitigation plan and help the CTM to follow up with the study team.

Site Communication

• This role is not intended to be site-facing.

Persuasion / negotiation with the site staff focusing on study deliverables

• Provide clear and effective, technically accurate information and instructions both verbally and in writing.
• Maintain effective and timely communication with the site staff.
• Demonstrate active listening skills.
• Follow all communication pathways per study team requirements and ensure that it is properly documented.
• Identify and escalate privacy and confidentiality violations and implement corrective actions. Comply with global and local laws and PPD processes.
• Identify and escalate issues and implement corrective action.
• Document site communications appropriately.
• Use critical thinking to suggest effective corrective and preventive actions to the site.
• Act as the primary contact with the site relevant to clinical-monitoring tasks, effectively coordinating reach-outs to sites via video or teleconference, phone, and emails across the monitoring team with support.
• Work closely with the monitoring team to maintain frequent site-managment contact.
• Identify when the start-up team may benefit from support to resolve issues and remove barriers.
• Use critical thinking to identify the root cause of problems and coordinate a robust CAPA plan across the monitoring team, if applicable; discuss actions with the CTM and the LM.
• Use critical thinking to identify the root cause of problems and a robust CAPA plan, if applicable; discuss actions with the Remote CRA, the CTM, and the LM.
• Identify when communication should flow through the Remote CRA as the main contact with the site.
• Provide clear, effective, technically accurate information and instructions both verbally and in writing.
• Act as the primary contact with the site relevant to clinical-monitoring tasks, effectively coordinating reach-outs to sites via video, teleconference, phone, or email across the monitoring team with minimal support.
• Working closely with the team to maintain frequent site-managment contact.
• Use critical thinking to suggest effective corrective and preventive site actions to the Remote CRA.
• Clearly understand the responsibilities and tasks performed by each person at site and develop a strategic and efficient communication flow with site staff.
• Share success of issues resolution.
• Give support to the less-experienced CRAs with negotiation suggestions.
• Support the less-experienced start-up members with negotiation suggestions.
• Develop communication pathways per study team requirements and ensure that it is properly followed up and documented.
• Propose effective corrective and preventive actions suggestions to the study team.
• Compile and present proposed effective, corrective and preventive-action suggestions to the study team.
• Propose effective corrective and preventive-action suggestions and share them with the Remote CRA.

Industry Foundation

• Attain and maintain working knowledge of ICH-GCPs and applicable in-country regulation/legal/ethical framework and guidelines.
• Demonstrate basic knowledge of the product development lifecycle and significance of design features in clinical trial protocols.
• Possess basic knowledge of how drugs, devices, and biologics are developed and regulated.

Research Design

• Understand basics of the PPD business model and core values.
• Know protocol design: structure, critical sections, and critical information; identify potential clinical risks based on protocol design and disease indication.
• Understand the reporting requirements for global regulatory bodies relating to clinical-trial conduct.
• Recognize the importance of primary/secondary endpoints and their application to monitoring.
• Understand the roles of a Monitor and Site Sponsor as well as the regulatory framework and research ethics pertaining to ICH-GCP.
• Have fundamental knowledge of the Product Development Lifecycle and Significance of Design Features in Clinical trial protocols.
• Know all local compliance regulations /adhere to legal, ethical framework/guidelines.
• Know working country regulations, ICH GCP and requirements.
• Understandi PPD business model and core values.
• Know protocol design: structure, critical sections, critical information and identify potential clinical risk based on protocol design and disease indication.
• Understand the reporting requirements for global regulatory bodies relating to clinical trial conduct.
• Recognize importance of primary/secondary endpoints and their application to monitoring.
• Understand the roles of the monitor and  site  sponsor, as well as  the regulatory framework and ethics pertaining to ICH GCP.
• Continually verify adequacy of site staff qualification; site documentation, including policies & procedures and potential patient population for the protocol; and make a determination on site suitability for the trial.
• Escalate quality risk to the CTM regarding site staff when inadequacies/deficiencies are identified at the site; document in work order any quality risks for on-site CRA awareness to review during a triggered on-site visit with support.
• Ensure all activities are closely supervised by the People Manager and the CTM, or by an experienced Monitor on larger studies.
• Verify adequacy of site staff qualification; examine site facilities, site documentation (policies & procedures), and potential patient population for the protocol; and make a determination on site suitability for the trial during on-site visits with some support from a People Manager or a CTM, or by an experienced Monitor on larger studies.
• Verify that facilities remain adequate to perform the trial and compliant with ICH-GCP and applicable regulatory framework, with some support from a People Manager or a CTM, or by an experienced Monitor on larger studies as needed.
• Escalate quality risk to the Remote CRA and CTM regarding site staff when inadequacies/deficiencies are identified at the site, with some support from a People Manager; or escalate quality risk to an experienced Monitor on larger studies as needed.
• Possess advanced knowledge of the product development lifecycle phases and list the key protocol design sections.
• Have functional experience regarding how drugs, devices, and biologics are developed and regulated.
• Possess knowledge of protocol research methodology and the primary and secondary endpoints.
• Maintain operational knowledge of and comply with/adhere to legal, ethical framework/guidelines and regulations.
• Have operational knowledge regarding and understand the significance of country regulations and requirements.
• Maintain operational understanding of the PPD business model and core values and how they relate to personal performance within the monitoring role.
• Continually verify adequacy of site staff qualification; and examine site facilities, site documentation (policies & procedures), and potential patient population for the protocol; and make a determination on site suitability for the trial.
• Review site knowledge/compliance with protocol and ICH-GCP before and during project implementation.
• Verify that staff and facilities remain adequate to perform the trial and compliant to ICH-GCP and regulatory framework.
• Escalate quality risk regarding site staff when inadequacies/deficiencies are identified at site.
• Maintain awareness of other PPD functional areas and services delivered across study teams.
• Escalate quality risk to the CTM regarding site staff when inadequacies/deficiencies are identified at site and document in the work order any quality risks for on-site CRA awareness to review during triggered on-site visits.
• Ensure all activities are supported by a People Manager and the CTM, or by an experienced Monitor on larger studies.
• Verify adequacy of site staff qualification; examine site facilities, site documentation (policies & procedures), and potential patient population for the protocol; and make a determination on site suitability for the trial during on-site visits.
• Verify facilities remain adequate to perform the trial and compliant with ICH-GCP and applicable regulatory framework.
• Escalate quality risk to the Remote CRA and the CTM regarding site staff when inadequacies/deficiencies are identified at the site.
• Fully understand the different product development lifecycle phases and list the key protocol design sections.
• Have detailed experience regarding how drugs, devices, and biologics are developed and regulated.
• Actively demonstrate PPD core values in their everyday performance and monitoring tasks.
• Have practical experience in and discuss the significance of primary/secondary endpoints and application to monitoring.
• Have experience with site assessments, verification of site staff qualifications adequacy, examination of site facilities, site documentation (policies & procedures), potential patient population projections for the protocol and the making of a determination on site suitability to participate in the trial.
• Independently implement corrective and preventative action (CAPA) with regard to site staff and experience/training.
• Provide mentoring and training in all facets of the clinical research industry, including all previous bullet-pointed areas.
• Possess operational understanding of the PPD business model and core values, including demonstrable performance and experience as a mentor, coach, and trainer.
• Provide mentorship to others on protocol design: Structure, critical sections, critical information and potential clinical risk identification based on protocol design and disease indication.
• Write potential mitigation strategies to identified clinical risks and have demonstrable experience mitigating against clinical risks.
• Provide oversight and mentorship of others with site staff training and adequate documentation.
• Independently apply critical thinking skills to problems, perform RCA, and implement corrective and preventative action for all site staff quality risks (CAPA).
• Serve as a mentor for and trainer of others on research design and  business models.
• Evaluate areas of potential risk based on therapeutic areas and disease area of study.

Therapeutic Area (TA) Knowledge Work Prioritization and Scheduling

• Know the basics of medical/therapeutic areas and have a sound foundation of medical terminology.
• Take responsibility for ensuring all required tasks have been well understood and the timelines agreed upon.
• Proactively ask for support from the Remote CRA and/or PeM regarding how to complete tasks.
• Evaluate assignments and prioritize and manage work activities according to study plans.

Plans and Conducts Remote Monitoring and Monitoring Visits

• Not Applicable

Safety Oversight

• Know protocol-specific requirements regarding safety and adverse events.
• Be aware of the methods by which safety issues are identified and managed.
• Differentiate the types of adverse events that occur during clinical trials and gain an understanding of the identification/reporting process related to regulatory authorities, sponsors, and IRBs/IECs.

Therapeutic Area (TA) Knowledge

• Maintain general knowledge of different diseases/disorders, biologic & pharmaceutical agents.
• Understand the basics of the therapeutic area in order to monitor and ensure subject safety/data integrity.
• Possess a sound foundation of medical terminology.
• Explain the study-assigned disease condition, identify signs/symptoms and documentation of diagnosis in source.
• Describe the indication and standard of care.

Work Prioritization and Scheduling

• Take responsibility for own visit planning and ask  questions to ensure all required tasks have been well understood and the timelines agreed upon.  Proactively ask for support from the CTM and/or PeM on  how to prioritize and schedule.
• Evaluate assignments, prioritize and manage work activities according to study plans.
• Plan visit activities and share with stakeholders so that an assessment of activity levels can be monitored.
• Escalate visit activity risks to ensure internal team mitigate effectively to achieve on-time deliverables.

Plans and Conducts Monitoring Visits. 

• Know and adhere to monitoring plans, standard operating procedures, and other written procedures in reference to conducting monitoring visit (PSVs. SIVs, IMVs, COVs).
• Demonstrate potential to be mentored and to manage complex issues with study visit scheduling and planning, including appropriate visit forecasting.
• Manage issues with the planning and conduction of monitoring visits with support and escalate potential risks to visit deliverables to appropriate team/manager.
• Ensure proper time is planned for monitoring visits to be certain all activities are completed as required.
• Show flexibility when working with site staff for scheduling of visits and completion/timing of activities while onsite.
• Persevere  through all required elements of a site visit in spite of opposition or difficulty.
• Identify subject safety risks and issues in source documents.
• Understand safety reporting process for PPD/client, in addition to the regulatory agencies for both pre- and post-approval.
• Be aware of the methods by which safety issues are identified onsite and managed.
• Differentiate the types of adverse events that occur during clinical trials and understand the identification/reporting process related to regulatory authorities, sponsors and IRBs/IECs.
• Share concerns for timely completion of monitoring tasks and request additional resources from internal team to achieve on-time deliverables.
• Explain the study-assigned disease condition to the startup team and on-site monitoring team based on their level of experience.
• Describe therapeutic indication and standard of care to the start-up and on-site monitoring team based on their level of experience.
• Effectively coordinate the activitites of monitoring team with some PeM, CTM, or experienced monitor support.
• Take responsibility for generating the on-site CRA work order (WO); ensure tasks required to be completed by the on-site CRA are outlined in the WO and are well understood and that the timelines are agreed upon by the on-site CRA.
• Proactively ask for support from the CTM and/or PeM regarding how to generate the WO.
• Prepare the SIA work order including FU actions related to Systems & Supplies, Essential Documents (including SRAP), and other pending site issues; and determine the method for SIA (Site Initiation Assessment) in consulation with the STM/CTM.
• Manage issues related to the planning and conduction of Site Management Contacts and ongoing remote site-monitoring activities; generate the WO with support; and escalate potential risks to visit deliverables to the appropriate team/manager.
• Demonstrate the potential to be mentored and to manage complex issues related generating on-site CRA work orders (WOs), including assessing whether there is enough work to support an on-site IMV.
• Take responsibility for visit planning once requested by Remote CRA and ask questions to ensure all required tasks outlined in the on-site CRA work order (WO) have been well understood and the timelines agreed upon.
• Manage issues related to the planning and conduct of monitoring visits with support, and escalate potential risks to visit deliverables to the Remote CRA or Manager.
• Have experience in different diseases/disorders, biologic & pharmaceutical agents.
• Demonstrate knowledge and experience in appropriate therapeutic area (TA) in order to monitor SD and ensure subject safety/data integrity.
• Possess comprehensive knowledge of medical terminology.
• Proactively review risks to planned visits/escalate as needed.
• Ensure escalation of visit activity risks to be sure the  internal team mitigates effectively to achieve on-time deliverables.
• Share concerns for timely completion of monitoring tasks and request additional resources to internal team to achieve on-time deliverables.
• Volunteer to help the study team with monitoring tasks when time is available. Seek guidance from management for alternate site assignments and/or tasks to maintain appropriate utilization.
• Monitor own upcoming utilization and work with management to find tasks to maintain appropriate utilization.
• Proactively manage visit scheduling and planning across studies with minimal assistance.
• Negotiate effectively with site staff to ensure monitoring visits occur within protocol-required visit window.
• Complete all required monitoring tasks during onsite and remote monitoring and fully document and escalate any tasks not completed along with risk mitigation plans.
• Know specific sections of the protocol dealing with subject safety in tandem with the fundamental ethical principles of protection of subject rights, safety, and well-being.
• Identify unreported subject safety risks and issues in source documents.
• Oversee site safety-reporting process for PPD/client and ensure regulatory submission and review.
• Know and oversee the methods by which safety issues are identified onsite and managed.
• Explain the study-assigned disease condition to the start-up team and on-site monitoring team based on their level of experience.
• Effectively coordinate the activitites of monitoring team with some PeM, CTM, or experienced Monitor support.
• Take responsibility for generating the on-site CRA work order (WO), ensurinng tasks required to be completed by the on-site CRA are outlined in the WO and are well understood, and that the timelines are agreed upon by the on-site CRA.
• Prepare the SIA work order including FU actions related to Systems & Supplies, Essential Documents (including SRAP) and other pending site issues; and determine method for SIA (Site Initiation Assessment) in consulation with the STM/CTM.
• Manage issues with the planning and conduct of Site Management Contacts, ongoing remote site-monitoring activities, generation of the WO with support; and escalate to the appropriate team/manager potential risks to visit deliverables.
• Demonstrate potential to be mentored and to manage complex issues related to generating on-site CRA work orders (WOs), including appropriate assessement as to whether there is enough work to support an on-site IMV.
• Proactively review risks to planned visits and escalate to the Remote CRA as needed.
• Share concerns for timely completion of monitoring tasks and request additional resources from the Remote CRA to achieve on-time deliverables.
• Understand the various risks and challenges for the different therapeutic areas.
• Proactively research and train to learn new medical terminology as required for study assignment and to maintain competency in basic areas.
• Evaluate risks and benefits of IP on the disease or condition.
• Mentor and assist others in evaluating assignments, prioritization and managing work activities efficiently and effectively according to study plans.
• Assist study management with review of site assignments and proactively suggest cost-effective site-assignment revisions.
• Volunteer to assist others during lower utilization time periods and escalate to manager when assistance maintaining expected utilization is needed.
• Provide assistance to others with adherence to monitoring plans, standard operating procedures, and corporate policies and PPD position statements in reference to conducting monitoring visit (PSVs. SIVs, IMVs, COVs).
• Pre-emptively escalate risks to MPs and SOPs fulfilment for planned deviations to be implemented.
• Apply critical analysis to manage complex site and monitoring visit-conduct issues independently.
• Effectively identify and resolve challenging site and monitoring problems at a role-model level.
• Demonstrate experience and knowledge of specific sections of the protocol dealing with subject safety in tandem with the fundamental ethical principles of protection of subject rights, safety, and well-being.
• Proactively resolve site issues pertaining to protection of subject rights, safety and well-being.
• Identify subject safety risks, mitigation strategies, and effective resolution of issues in subjects’ documents independently.
• Oversee safety-review documentation,  resolve issues arising within the site, and review site processes to ensure they address all required safety needs.
• Implement innovative strategies and use critical thinking in handling identified safety issues and turn-around strategies in CAPA implementation.
• Mentor and assist the monitoring team in evaluating assignments, prioritization, and managing work activities efficiently and effectively according to study plans.
• Provide others with insight and training in different diseases/disorders, biologic & pharmaceutical agents.
• Coach, mentor/train in the disease condition, identify signs/symptoms and document diagnosis in source, standard of care.
• Evaluate risks and benefits of IP on the disease/condition.
• Instruct and guide others on the team regarding the disease/condition.
• Provide assistance to study management in ensuring the monitoring team meets expected deliverables and maintain appropriate utilization.
• Assist management with assigning site to monitors in order to manage budget, geographical, and experiential needs.
• Demonstrate experience in coaching and mentorship in all monitoring tasks both onsite and remote.
• Mentor other monitors with escalating risks and suggested mitigation strategies to visit deliverables to appropriate team/manager.
• Procure adequate resources to ensure rate of source data review is adequate to protect patient safety and promote data integrity.
• Effectively partner with others to realize completion of all monitoring tasks when needed.
• Assist with the reviews of safety document oversight for the study team and proactively follow up on missing and incorrect safety information.
• Demonstrate experience in coaching and mentorship in all monitoring tasks, both on-site and remote.
• Coach, mentor/train others in the therapuetic area.
• Instruct and guide others on the team regarding the therapuetic area.
• Assist management with assigning site to monitors in order to manage budget as well as geographic and experiential needs.
• Know the impact of therapeutic area competences on the project/study.
• Fully understand business impact on project/study of work prioritization and scheduling, as well as risks when study tasks are not completed as expected.
• Provide oversight of monitoring deliverables for assigned study team and proactively address and escalate any potential risks to project workload and timelines.
• Know and be fully conversant with the impact on project/study of planning and conduct monitoring visits.
• Know the  impact of safety and appropriate, related documentation on project/study level.
• Provide study team training and oversight of study safety documentation and processes.
• Provide study-team training and oversight on study safety documentation and processes.
• Complete and record role-specific and project-related training within defined timelines in the PPD Learning Management System.
• Submit and update CVs as per policy.
• Have a basic understanding of clinical research environment and PPD business, mission, vision, and defining principles.

Audits and Inspections

• Assist in ensuring that files are audit-ready and complying with systems and eTMF data stewardship.
• Contribute to the development of audit/inspection response with oversight by the Remote CRA.

Site Compliance & Communication including sPIP

• Identify deviations from the protocol, SOPs, and the applicable regulatory requirements as well as document non-compliance according to project guidance.
• Protect study blind, if applicable.
• Ensure site file audit readiness.

Essential Documents and eTMF 

• Maintain a fundamental understanding of required essential documents according to ICH-GCP Section 8 as well as local regulations.
• Conduct quality checks of ISF content according to good documentation practices and applicable global guidance and regulations for currency with guidance and attention to detail.
• Follow the eTMF process and perform checks to verify that required documents are appropriately and promptly filed.
• Follow the timelines and accuracy of the Investigator’s payments and invoices.

ICH-GCP, PPD/Sponsor SOPs, Local Regulations & Requirements,

• Maintain a basic understanding of/review ICH-GCP, PPD, and/or sponsor SOPs, WPDs, local regulations and requirements, site SOPs, ISF, good documentation practices, and ALCOA principles.
• Assess compliance with applicable processes and requirements throughout the trial with Remote CRA support.
• Identify and escalate non-compliance to the Remote CRA and discuss potential corrective and preventative actions with Remote CRA support.

Monitoring Plan

• Collaborate with the Remote CRA to identify potential areas of concern.

Electronic Record Requirements 

• Understand, maintain, and comply with PPD/sponsor SOPs as they relate to site documentation of the EMR/HER system.
• Understand and follow the  PAV process.
• Understand clinical research environment and PPD business, mission, vision, and defining principles.
• Follow PPD/sponsor procedures for hosting/supporting client audits, routine clinical investigator site audits, process audits, managing GxP regulatory inspections, and  other procedures for specific audit types with support.
• Provide support on site, if  client agrees, or remotely.
• Distribute the summary report per  the distribution list.
• Communicate with site personnel, PPD QA, and project leadership.
• Assist the site and project team in the development of audit / inspection response in a collaborative manner.
• Develop collaborative relationships with investigational sites by appropriate methods to communicate effectively.
• With support, assess site capabilities and develop plans to support the site to achieve compliance, e.g., via training, ongoing communication and procurement of relevant study tools.
• Identify deviations from the protocol, SOPs, and the applicable regulatory requirements, and document non-compliance as per project guidance.
• Escalate issues and confirm ethics committee reporting as required.
• With support, discuss and come to agreement with the site on corrective and preventive actions by listening closely.
• Follow up in a timely manner to verify compliance and perform effectiveness checks where required.
• Ensure audit readiness with accountability.
• Retrain site personnel as needed with support.
• Understand required Essential Documents according to ICH-GCP Section 8 along with local regulations.
• Provide quality checks of ISF content in line with  Good Document practices and applicable global guidance and regulations for currency with guidance and attention to detail.
• Follow eTMF process. Perform QC to verify the document meets applicable standards as per guidance.
• Verify that the investigator is aware of ISF maintenance and archiving responsibilities and has plans to comply with requirements.

ICH-GCP, PPD/Sponsor SOPs, Local Regulations & Requirements, Site SOPs and ISF, Good Documentation Practice, ALCOA principles

• Understand and review ICH-GCP, PPD and/or sponsor SOPs, WPDs, local regulations & requirements, site SOPs, ISF, Good Documentation Practice and ALCOA principles.
• Holistically assess compliance with applicable processes & requirements throughout the trial with support when needed.
• Identify and escalate non-compliance and implement corrective and preventative actions with support.
• Understand and comply with monitoring plan requirements with support.
• Collaborate with study team to address potential areas of concern.
• Understand, maintain, and comply with PPD/sponsor SOPs and mitigate risk with site as it relates to EMR/EHR with support.
• Comply with and regularly verify site and local regulatory EMR requirements and/or SOPs.
• Act as the main contact point for issue resolution and coordinate efforts across the monitoring team with some support.
• If the client agrees, provide support remotely to the on-site CRA.
• Remain aware of all data reports and tools available to support CRA monitoring activities and ask for mentoring as needed to ensure knowledge and understanding of all available reports, dashboards, and tools supporting data review.
• Act as the main contact with the site to assess site capabilities and develop plans to support the site to achieve compliance, e.g., training, ongoing communication and procurement of relevant study tools with some support.
• Assimilate all instances of non-compliance identified across the monitoring team and implement holistic corrective and preventative actions with support.
• Lead a discussion and come to an agreement with the site on corrective and preventative actions with support.
• Be the primary collaborator with the site to ensure adequate implementation of corrective and preventative actions, with some support.
• Ensure the site is aware of the role of the Remote CRA as the main contact point for issue resolution.
• Maintain effective communications with the Remote CRA.
• Provide support on site if the client agrees with some support from the Remote CRA, the CTM, and the People Manager.
• Supported by and the direction of the Remote CRA , assess site capabilities and develop plans to support the site to achieve compliance, e.g., training, ongoing communication, and procurement of relevant study tools.
• Communicate with site personnel, PPD QA, Remote CRA, and project leadership with some support from the People Manager.
• With support from the Remote CRA, discuss and come to agreement with the site on corrective and preventive actions by listening closely; and ensure that site personnel are aware that the Remote CRA is main contact point.
• Seek additional training options, internally and externally.
• Follow PPD/sponsor procedures for hosting and supporting client audits, routine clinical investigator site audits, process audits, managing GxP regulatory inspections and  other procedures for specific audit types, with limited support.
• Share lessons learned and planning tools with other team members.
• Discuss and agree with the site on corrective and preventative actions.
• Retrain site personnel as needed with minimal support by developing presentation skills.
• Collaborate with site to ensure adequate implementation of corrective and preventative action(s), with minimal support.
• Provide quality and currency checks of ISF content in line with Good Documentation Practices, as well as applicable global guidance and regulations.
• Identify and escalate instances of non-compliance and implement corrective and preventative actions with minimal support.
• Understand and comply with Monitoring Plan requirements with minimal support.
• Understand, maintain, and comply with PPD/sponsor SOPs and mitigate risk with site as it relates to EMR/EHR, with limited support.
• Act as the main contact point for issue resolution and coordinate efforts across the monitoring team with minimal support.
• Provide support remotely if the client agrees and provide support to the on-site CRA.
• Be aware of all data reports and tools available to support CRA monitoring activities and ask for mentoring as needed to ensure knowledge and understanding of all available reports, dashboards, and tools supporting data review.
• Act as the main contact with the site to assess site capabilities and develop plans to support the site to achieve compliance, e.g., training, ongoing communication, and procurement of relevant study tools with limited support.
• Assimilate all instances of non-compliance identified across the monitoring team and implement hoslitic, corrective, and preventative actions with minimal support.
• Lead a discussion and come to agreement with the site on corrective and preventative actions.
• Be the primary collaborator with the site to ensure adequate implementation of corrective and preventative actions, with minimal support.
• Identify and escalate instances of non-compliance to the Remote CRA and work to implement corrective and preventative actions with minimal support.
• Effectively share with the Remote CRA any discussion and agreement with the site on corrective and preventative actions.
• Collaborate with the Remote CRA to ensure site adequately implements corrective and preventative actions, with minimal support.
• Communicate with site personnel, PPD QA, Remote CRA, and project leadership with minimal support.
• Understand, follow and contribute to  PAV process.
• Mentor and provide project-related training.
• Incorporate PPD Defining Principles into daily work.
• Assist the site and project team in the development of audit / inspection responses and corrective/preventative action plans.
• Conduct trend analysis and escalate as needed.
• Mentor junior monitors in dealing with non-compliant sites.
• Identify trends across study sites and escalate issues.
• Identify and escalate non-compliance and implement corrective and preventative actions.
• Propose action plan to project teams for resolution of issues/events.
• Perform root cause analysis, evaluate process gaps and use available resources to develop and implement corrective and preventative  actions.
• Independently act as the main contact point for issue resolution and coordinate efforts across the monitoring team.
• Mentor junior on-site monitors, on larger studies, in dealing with non-compliant sites.
• Collaborate with Remote CRA and study team to address potential areas of concern.
• Support junior monitors in understanding and interpreting received trainings and apply them as it relates to quality and risk-management practices.
• Provide training as needed.
• Assist the site and  project team, mentor junior monitors with the development of audit / inspection responses and corrective/preventative action plans, and align communication.
• Escalate issues, verify/complete  documentation of non-compliance in system of record, and confirm ethics committee reporting as required.
• Communicate difficult information diplomatically.
• Conduct trend analysis, identify root cause and risk to study, and escalate as needed.
• Recommend solutions for issues and mentor junior monitors on issue resolution.
• Mentor and support junior monitors in terms of compliance.
• Mentor and provide guidance to junior monitors on electronic record requirements.
• Assist the site and project team, mentor Junior Monitors with the development of audit/inspection responses and corrective/preventative action plans, and align communication.
• Mentor and support Junior Monitors on issue resolution and electronic record requirements.
• Mentor and support junior team members in terms of compliance.
• Mentor and support on-site Junior Monitors on larger studies regarding issue resolution and electronic record requirements.
• Mentor and support on-site Junior Monitors on larger studies regarding terms of compliance.
• Demonstrate a high level of expertise and provide support to project teams and/or clinical managers; mentor , train, and contribute to the development of junior monitors.
• Assist in project-specific training for the clinical team as necessary.
• Identify areas for potential process improvements, share potential solutions, and  implement where appropriate based on audit/inspection outcomes.
• Provide updates on potential trends across multiple sites and discuss potential strategies for site management with project teams.
• Act as a role model and relationship builder when communicating with sites.
• Share knowledge through training and supervise junior monitors for ISF content.
• Proactively identify trends or gaps and provide recommended solutions to project teams and/or clinical teams.
• Support people manager in the development of junior clinical team members.
• Support project teams and/or clinical teams to identify, analyze, and interpret data for monitoring non-compliance issues.
• Serve as an expert and support clinical team members.
• Act as the primarly role model and relationship builder when communicating with sites.

Effective Risk Management 

• Identify potential risks; and assess, manage, and escalate to the Remote CRA when necessary with support.
• Understand and utilize escalation pathways when appropriate.
• Contribute to mitigation plans with support.

RCA & CAPA and Documentation 

• Understand RCA, CAPA process, action plans, and effectiveness checks with support.
• Consult the People Manager or the Remote CRA when needed prior to making decisions.
• Regularly monitor for sustained performance and/or continual improvement.
• Verify documentation of the process and follow up when necessary.
• Identify potential risks; assess, manage, and escalate when necessary with support.
• Understand and utilize escalation pathways when appropriate. Implement mitigation plans with support.
• Complete KRI review and evaluate Site Health Assessment prior to each monitoring visit.
• Communication with CTM to initiate quality-related queries via AskCQA.
• Understand and implement RCA and CAPA process and implement action plan and effectiveness checks with support.
• Consult people manager or CTM when needed prior to taking decisions.
• Act as main escalation point across the monitoring team and drive issues to resolution with some support.
• Perform KRI and site health asessement during the remote review period and prior to site-management calls with some support.
• Trigger an on-site visit work order, as needed, based on continous KRI review with some support.
• Oversee the implementation of the action plan and effectiveness checks with some support.
• Maintain escalation pathways with the Remote CRA.
• Ensure remote CRA is consulted prior to making decisions.
• Complete the on-site work order and KRI review and evaluate site health assessment prior to each monitoring visit.
• Identify potential risks; assess, manage, and escalate when necessary with minimum support.
• Understand and utilize escalation pathways when appropriate. •Implement mitigation plans with minimum support.
• Act as the main escalation point across the monitoring team and drive issues to resolution with minimal support.
• Perform ongoing KRI and site health asessement during the remote review period and prior to site management calls with minimal support.
• Trigger an on-site visit work order as needed, based on continous KRI review with minimal support.
• Oversee the implementation of the action plan and effectiveness checks with minimal support.
• Identify potential risks; assess, manage, and escalate when necessary.
• Understand and utilize escalation pathways when appropriate.  •Implement mitigation plans.
• Perform risk-assessment analysis and CAPA plans.
• Proactively propose action plans.
• Implement mitigation plans.
• Mentor junior monitors on the use of root cause analysis tools and the development of action plans.
• Mentor Junior Monitors on the use of root-cause analysis tools and the development of action plans.
• Mentor on-site Junior Monitors on larger studies regarding the use of root-cause analysis tools and the development of action plans.
• Identify site trends across multiple studies and escalate issues to managment.
• Identify trends across assigned sites and escalate issues to managment.
• Proactively propose actions plans and mitigation strategies.
• Provide support to project teams.
• Identify trends across study sites  and escalate issues. •Recommend solutions to issues and mentor junior monitors on issue resolution.
• Support clinical team members in the area of CAPA management and assist people manager in oversight of CAPAs.

Subject Confidentiality, Data Protection and Privacy

• Identify confidential information and comply with PPD SOPs and all applicable laws and guidelines.
• Detect cases after review of the documents, escalate to the Remote CRA, and gain the ability to take actions for remediation with guidance.
• Recognize any breaches as per procedures and raise to the Remote CRA.

Informed Consent Process

• Gain experince in Remote eConsent review; escalate any identified informed-consent deviations and follow-up for resolution with support.

Scientific Misconduct

• Recognize signs of misconduct and raise them to the Manager or Remote CRA.
• Immediately report suspicions of misconduct through management and to the Remote CRA.
• Assist as needed with the collection and submission of additional information with respect to misconduct.
• Maintain strict confidentiality of all information except for the reporting requirement.
• Consult with line management and the Remote CRA.
• Carefully document specific evidence of any suspicion of scientific misconduct.
• Cooperate with any third-party investigation of suspected scientific misconduct and/or questionable data practices.
• Detect cases after review of the documents and take immediate actions for remediation with guidance.
• Complete documentation and retrain the site.
• Identify and report the breach as per procedures.
• Determine if the subject was consented appropriately prior to subject participation and verify informed-consent documentation per relevant guidelines and regulations.
• Verify evidence that the subject was kept informed during the study.
• Identify, escalate, and document informed-consent deviations and follow-up for resolution with support.
• Identify signs of misconduct.
• Immediately report suspicions of misconduct through management and appropriate reporting pathways.
• Consult with line management, project management or GQC on the immediate actions to take.
• Cooperate with any third-party investigation of suspected scientific misconduct and questionable data practice.
• Seek guidance on how to facilitate corrective and preventative action plan.
• Tactfully discuss concerns with the principal investigator, listen before taking any actions, and implement action plan with support from stakeholders.
• Tactfully discuss concerns with the Principal Investigator, listen before taking any actions, and lead the implement action plan with some support from stakeholders.
• Tactfully discuss concerns with the Principal Investigator, listen before taking any actions, and implement action plan as agreed with the Remote CRA and stakeholders.
• Detect cases after review of documents and take immediate actions for remediation.
• Identify, escalate, and document informed consent deviations and follow up for resolution with minimal support.
• Tactfully discuss concerns with the principal investigator, listen before taking any actions, and implement action plan with limited support from stakeholders.
• Tactfully discuss concerns with the Principal Investigator, listen before taking any actions, and lead the implement action plan with minimal support from stakeholders.
• Tactfully discuss concerns with the Principal Investigator, listen before taking any actions, and implement an action plan as agreed upon with Remote CRA and stakeholders.
• Perform root cause analysis and implement preventative and corrective actions.
• Identify, escalate, and document informed consent deviations and follow-up for resolution.
• Tactfully discuss concerns with the principal investigator, listen before taking any actions, and implement action plan.
• Share lessons learned while maintaining confidentiality.
• Mentor junior monitors on detection and remediation of cases.
• Mentor junior monitors on identification, escalation and reporting of informed consent findings and deviations.
• Mentor Junior Monitors on detection and remediation of cases.
• Mentor Junior Monitors on identification, escalation, and reporting of informed consent findings and deviations.
• Mentor on-site Junior Monitors on larger studies regarding the detection and remediation of cases.
• Mentor on-site Junior Monitors on larger studies regarding the identification, escalation, and reporting of informed-consent findings and deviations.
• Assist project teams when needed as a resource and support people managers in mentoring, training, and contributing to the development of junior clinical team members.
• Provide updates on potential trends across multiple sites and discuss potential strategies for issue management with project teams.
• Assist project and/or clinical team management in addressing suspected cases of misconduct as requested or assigned.

• Privacy Policy

Clinical Manager - Clinical Research Associate

🔍 vietnam, vietnam.

Responsible for the line management, selection, training, coaching and performance management of Clinical Research Associates. Focusing on end results to be achieved, uses metrics and key performance indicators to manage individual and team performance. May lead the Clinical Management team for a country or geographic area, or may lead or contribute to initiatives that enhance Clinical Development/PPD business objectives. Lead and/or participate in local and regional cross functional initiatives and process improvement projects.

• Significant clinical research experience (comparable to 4 years) including clinical monitoring and experience in all phases of study life cycle, including start up, interim and close out.
• Line management experience appropriate to the size and complexity of the clinical management group in the designated country/region.
• Valid Driver’s License.
• Valid Passport.
• Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities.

Knowledge, Skills and Abilities :   

• Demonstrate effective mentoring/leadership/supervisory ability including excellent interpersonal skills.
• Excellent clinical trials monitoring skills.
• Demonstrate understanding of or ability to learn and demonstrate understanding of PPD SOPs, WPDs, and relevant regulations e.g. ICH/GCP, FDA guidelines).
• Demonstrate ability to evaluate medical research data and demonstrate proficient knowledge of medical terminology.
• Effective organizational and negotiation skills.
• Strong attention to detail.
• Effective written and oral communication skills.
• Good knowledge of English language and grammar.
• Competent use of computer to include data entry, archival and retrieval.
• Ability to travel as needed.
• Excellent team player with team building skills.
• Excellent interpersonal and conflict resolution skills.
• Utilize problem-solving techniques applicable to constantly changing environment.
• Proficient knowledge of medical/therapeutic areas and medical terminology.
• Requisition ID: 154321

Clinical Monitoring ​​​​​​​& Operations

What our team offers:, hear from our colleagues:, tell us about yourself:, i want to become a cra, i am an experienced cra, i want to become a cra if you hold a bachelor’s or master’s degree in life sciences or a clinical research field, have completed coursework in medical terminology and anatomy/physiology, and have a strong interest in the pharmaceutical industry, you may qualify. you can join as a clinical trial coordinator (ctc), assistant clinical research associate (acra), or country approval specialist (cas) and advance to the cra role. alternatively, if you are a clinician with five or more years of experience, you may transform your career to work in the clinical research industry with our clinician to cra program., what area interests you, i'm an experienced cra, discover our stories & learn more:, join our talent community.