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How to Become a Clinical Research Coordinator

Unlock the pathway to a rewarding career as a Clinical Research Coordinator with insights on duties, CCRC certification training options, and salary expectations. 

In the rapidly advancing field of healthcare and medical research, Clinical Research Coordinators (CRCs) play a pivotal role. As the backbone of clinical trial operations, they not only ensure the seamless execution of studies but also bridge the gap between innovative medical discoveries and enhanced patient outcomes. 

By meticulously managing research protocols and ensuring compliance with ethical standards, CRCs are instrumental in translating medical breakthroughs into tangible healthcare improvements. Their dedication to patient safety and advocacy further underscores their essential contribution to the future of medicine and patient care. 

Here, we’ll explore what the role entails, career and education pathways and next steps for you to become a Clinical Research Coordinator . 

What is a Clinical Research Coordinator?

In the world of medical research, a Clinical Research Coordinator (CRC) makes sure that research studies and clinical trials run smoothly and effectively. Imagine them as the glue that holds together everyone involved, from doctors and scientists to the participants in the studies.

At its core, a CRC ensures that research follows all the rules, ethical standards, and laws. They are the ones who oversee the day-to-day operations of a study, making sure everything happens according to the plan. Picture yourself as the captain of a ship—organize your crew (participants and healthcare professionals), navigate the course (protocol adherence), keep a detailed log (data management), and ensure your ship follows all maritime laws (regulatory compliance).  

Primary Duties and Responsibilities:

A Clinical Research Coordinator (CRC) ensures every note is played perfectly in the symphony of clinical trials and research studies. Let's break down the key tasks that make up their daily score:

• Clinical Trial Coordination:
•    Develop and implement study protocols.
•    Coordinate all aspects of clinical trial activities.
•    Collaborate with investigators, sponsors, and regulatory authorities.
• Participant Recruitment and Screening:
•    Devise recruitment strategies.
•    Screen and enroll eligible participants.
•    Maintain accurate participant records.
• Document and Record Management:
•    Maintain comprehensive study documentation.
•    Ensure compliance with regulatory and ethical standards.
•    Prepare and submit regulatory documents.
• Regulatory Compliance:
•    Monitor and ensure adherence to regulations.
•    Facilitate IRB submissions and address compliance issues.
• Safety and Supply Management:
•    Implement safety protocols.
•    Monitor and manage study-related materials and supplies.
• Cost Analysis and Budgeting:
•    Conduct cost analysis and prepare budgets.
•    Track expenditures and adhere to budget constraints.
• Training Programs:
•    Design and deliver training for staff and participants.
•    Ensure all team members are well-versed in protocols.
• Data Collection and Maintenance:
•    Collect and maintain accurate study data.
•    Implement quality control measures.
• Participant Point of Contact:
•    Act as the main contact for participants.
•    Address participant questions and concerns.
• Study Promotion:
•     Promote the study through various channels.
•     Collaborate on marketing and outreach efforts.

How Much Do Clinical Research Coordinators Get Paid?

Understanding the compensation landscape is essential as you consider a career as a Clinical Research Coordinator (CRC). Salaries for CRCs can vary based on several factors, providing a range of earning potential. On average, entry-level CRCs can expect a salary in the range of $45,000 to $60,000 per year. As you gain experience and expertise in the field, mid-level CRCs typically earn between $60,000 and $80,000 annually. Those with advanced skills and a wealth of experience, such as Senior Clinical Research Coordinators, can command salaries exceeding $90,000 per year.

It's important to note that the geographical location can significantly impact salaries. Metropolitan areas and regions with a high demand for clinical research professionals tend to offer higher compensation to attract and retain top talent. For instance, CRCs working in urban centers may earn salaries at the upper end of the pay scale compared to those in rural areas.

In addition to base salaries, many CRCs receive benefits such as health insurance, retirement plans, and bonuses tied to the success of clinical trials. Furthermore, opportunities for career advancement, continuing education, and professional development can enhance the overall compensation package.

Research average salaries in your desired location and industry to align your salary expectations with the prevailing market rates. Equip yourself with negotiation skills and insights into maximizing your earning potential as you embark on this fulfilling career path.

CCRC Certification Requirements:

The Certified Clinical Research Coordinator (CCRC) credential is your passport to credibility in the field. The certification, recognized globally, showcases your dedication to excellence in clinical research. Leverage CCRC preparation resources, including practice exams and guidance from seasoned professionals, to increase your chances of success in obtaining this prestigious certification.

Pathways into the CRC role and beyond 

Embarking on a career as a Clinical Research Coordinator (CRC) involves a structured pathway to ensure you possess the necessary qualifications and skills . Here are the key steps to guide you on your journey:

Bachelor's Degree : Obtain a bachelor’s degree, preferably a Bachelor of Science in a relevant subject such as clinical research administration, health sciences, public health, microbiology, or a related field.

Work Experience : Gain practical experience in healthcare or clinical research. This can be achieved through internships, voluntary assignments, or entry-level roles in hospitals or research positions. This experience is crucial for developing the skills required in the field.

Master's Degree or Graduate Certificate : While a bachelor's degree is the minimum requirement, consider pursuing a master's degree or a graduate certificate to enhance your qualifications. Specialized subjects like clinical research, clinical administration, or clinical research management are advantageous. The flexibility of part-time or online study can accommodate your work commitments.

Certifications : Though not mandatory, obtaining a clinical research certification is recommended for career advancement. The Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SOCRA) offer certifications that validate your skills and competence. Options include:

• ACRP Certified Professional (ACRP-CP)
• Clinical Research Coordinator (CCRC)
• Clinical Research Associate (CCRA)
• Principal Investigator (CPI)
• ACRP Medical Device Professional Subspecialty (ACRP-MDP)
• ACRP Project Manager Subspecialty

The field of clinical research is dynamic, and continuous learning and adaptation are key to a successful career. By following these career pathway steps, you'll be well-prepared to navigate the complexities of clinical research coordination and contribute to groundbreaking advancements in healthcare.

Your Next Steps:

As you consider the exciting journey of becoming a Clinical Research Coordinator, explore CareerCatalyst’s Clinical Research Coordinator Program , designed to ensure that you are well-prepared to thrive in the future of clinical research.  

Develop the skills to succeed at every career stage.

You’re one step closer to leaving your footprint on the world. Request information today and we will be in touch with you shortly.

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Research Coordinator Vs Clinical Research Associate

The differences between research coordinators and clinical research associates can be seen in a few details. Each job has different responsibilities and duties. It typically takes 1-2 years to become both a research coordinator and a clinical research associate. Additionally, a clinical research associate has an average salary of $62,966, which is higher than the $48,974 average annual salary of a research coordinator.

The top three skills for a research coordinator include patients, informed consent and data collection. The most important skills for a clinical research associate are patients, informed consent, and CRA.

Research coordinator vs clinical research associate overview

What does a research coordinator do.

A research coordinator is responsible for assisting the development of research data from clinical trials and laboratory investigations under the supervision of a lead researcher or a research supervisor. In some cases, research coordinators conduct field investigations and analyze existing research materials upon understanding the scope and limitations of the study. They enter their findings and useful resources on the research database for reference to the research team. A research coordinator must have excellent communication skills , both written and oral, especially on gathering data and coordinating with other researchers for the progress and updates of the study.

What does a clinical research associate do?

A clinical research associate is responsible for assisting medical professionals in clinical trials and conducting research studies on medications and medical procedures. Clinical research associates monitor the research materials, ensuring its safety and reliability through trial procedures, writing comprehensive reports of results, and disseminating information across the concerned parties. They also provide recommendations on improving clinical processes, reiterating protocol requirements, and maintaining strict confidentiality of the trial subjects. A clinical research associate must have extensive knowledge of the medical industry, including its disciplines and principles, to perform duties accurately under minimal supervision.

Research coordinator vs clinical research associate salary

Research coordinators and clinical research associates have different pay scales, as shown below.

Differences between research coordinator and clinical research associate education

There are a few differences between a research coordinator and a clinical research associate in terms of educational background:

Research coordinator vs clinical research associate demographics

Here are the differences between research coordinators' and clinical research associates' demographics:

Differences between research coordinator and clinical research associate duties and responsibilities

Research coordinator example responsibilities..

• Manage participant's records ensuring confidentiality as well as NIH specifications.
• Manage all IRB submissions, sponsor communications, participate in monitoring visits, drug reconciliation and dispensing.
• Recruit, screen, conduct psychometric examinations and collect data for pharmaceutical clinical trials in patients diagnose with Alzheimer's disease.
• Maintain confidential information and appropriate ethical professionalism with highly sensitive personal health information; take part in IRB human subjects training.
• Assist in preparation of grants, NIH progress reports, presentations, and manuscripts.
• Ensure and maintain confidentiality, privacy and compliance of patient rights in accordance with HIPAA regulations and NVCI policies.

Clinical Research Associate Example Responsibilities.

• Manage, schedule and train up to 15 CRAs.
• Recruit patients, attain patient inform consent form, educate subjects on compliance, and ensure patient safety per ICH guidelines.
• Manage site TMF to ensure communication requirements adherence
• Manage CRO and regional monitor to complete close out activities, including device accountability management.
• Manage regional academic and community base oncology practices as the primary contact for all communications and support.
• Manage the monitoring CRO and the data clean-up efforts for a 510k submission and interim/annual study reports by effectively collaborating cross-functionally.

Research coordinator vs clinical research associate skills

• Patients, 11%
• Informed Consent, 8%
• Data Collection, 8%
• Research Projects, 6%
• Patient Care, 4%
• Patients, 9%
• Informed Consent, 7%
• Clinical Trials, 6%
• Clinical Trial Management, 5%
• Oncology, 4%

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Clinical Research Coordinator Associate

🔍 school of medicine, stanford, california, united states.

Clinical Research Coordinator for Cognitive Aging, Dementia, and Parkinson’s disease 

Do you want to help Stanford University develop world-leading research to better diagnose and treat people suffering from Parkinson’s disease, Dementia with Lewy Bodies and Alzheimer’s disease?

If you…

• Enjoy working directly with patients and their families.
• Are exceptionally organized and can balance multiple projects at one time.
• Love learning new skills, such as how to administer neurological and memory tests.
• Are a proven quick learner who doesn’t need handholding to get started.

Then we offer…

• The opportunity to contribute to understanding Alzheimer’s disease and Parkinson’s disease.
• Challenging but positive environment where you will always learn new things.
• Teamwork and camaraderie.
• Competitive full-time salary.
• Excellent Stanford benefits.

The Poston Lab recruits and follows older normal adults; older adults with mild cognitive impairment; and patients with Parkinson’s disease, Dementia with Lewy Bodies, Alzheimer’s disease, and related disorders. These studies collect information on memory and other mental abilities, which we link with brain imaging, biochemical and genetic markers, and autopsy results. Most research participants will have Parkinson’s disease, Dementia with Lewy Bodies, Alzheimer's disease, or another neurodegenerative disorder; some participants will be not have any impairment.    

The Poston Lab seeks a full-time Clinical Research Coordinator Associate. The desired candidate is self-motivated, detail-oriented, relatively independent, patient, punctual, and conscientious, with excellent interpersonal skills and excellent communication skills in English. Preference will be given to qualified candidates, who are also native/fluent in Spanish (written and verbal). Under the supervision of Dr. Poston and other investigators at the Stanford Alzheimer’s Disease Research Center (ADRC), main duties include in-person and telephone recruitment of research participants; obtaining informed consent; scheduling and coordination of research participant visits; maintaining longitudinal contact with participants by phone, email and other means; data collection (including psychometric data), scoring, and data entry.  Training will be provided to administer research questionnaires and administer psychometric tests.

We like working with other smart, motivated, fun people looking to better the lives of our patients through scientific discovery. In addition to submitting your on-line resume, please include a cover letter describing your prior clinical research experience and the top five attributes or experiences that make this the right job for you. For more information about our lab and research, please see http://neurology.stanford.edu/labs/postonlab/ .

Duties include*:

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.
• Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
• Coordinate collection of study specimens and processing.
• Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms. 
• Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure institutional Review Board renewals are completed.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
• Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct. 
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
• Participate in monitor visits and regulatory audits. 

*- Other duties may also be assigned.

DESIRED QUALIFICATIONS:

• Excellent verbal and written communication skills in English required.
• Excellent verbal and written communication skills in Spanish desired.
• Prior experience with patients or research subjects is desired. Preference given to applicants with previous experience, particularly clinical research experience, with older adults who may have neurological impairment (e.g., Parkinson’s disease) or cognitive impairment (e.g., Alzheimer’s disease). 
• Ability to communicate clearly and empathetically with research participants and their families.
• Strong interpersonal skills, including the ability to work easily with research participants and research team members.
• Strong general computer skills and ability to quickly learn and master computer programs.
• Strong analytical skills and experience with computer spreadsheets and database software.
• Proficiency with Microsoft Office and Excel.
• Ability to work under deadlines with general guidance.

EDUCATION & EXPERIENCE (REQUIRED):

Two year college degree and two years related work experience or a Bachelor’s degree in a related field or an equivalent combination of related education and relevant experience. 

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.

CERTIFICATIONS & LICENSES:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. 

PHYSICAL REQUIREMENTS*:

• Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. 
• Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
• Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

*- Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORKING CONDITIONS: 

Occasional evening and weekend hours.

WORK STANDARDS:

• Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
• Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu .

The expected pay range for this position is $31.73 to $36.54 per hour.

Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website ( https://cardinalatwork.stanford.edu/benefits-rewards ) provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form .

Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.

• Schedule: Full-time
• Job Code: 1013
• Employee Status: Regular
• Requisition ID: 102979
• Work Arrangement : On Site

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A description of Clinical Research Coordinator jobs and what they entail

Clinical research coordinators are usually supervised by clinical research managers. Their main task is to administer the clinical trials. Primary responsibilities normally include administering questionnaires, informing the participants about the objectives of the study, collecting data, and managing all the trials. They also have to adhere to all trial standards that have been set and also participate in recruitment of the subjects. Clinical research coordinators also have to engage with the subjects so that they can explain the things that are expected during the trial and also find out if they have any concerns. This means that a clinical research coordinator needs communicative and interpersonal skills.

For those interested in becoming clinical research coordinators, or enhancing their skills in this role, the Clinical Research Coordinator course provides comprehensive training and certification.

The responsibilities:

Maintaining records of all studies as per the guidelines.

Sticking to all ethical standards.

Sticking to all the regulatory standards set, including those covered in the ICH-GCP course .

Administering questionnaires.

Managing the budget dedicated to the research.

Overseeing the running of the trials as smoothly as possible.

Understanding and engaging with the subjects so as to know all issues.

Making sure that all equipment and supplies that are necessary for the success of the study are working and in stock.

Participating in the recruitment efforts of the participants, a topic extensively covered in the Clinical Trials Assistant Training .

Working with the laboratories so as to share findings.

Requirements:

The qualifications of a clinical research coordinator usually depend on your locations or employer. In most cases, for you to access clinical research coordinator jobs you should:

Have an associate nursing degree or any related field

Experience of two years within the healthcare industry

Analytical mindset

Be attentive to detail

Have interpersonal skills which are exceptional

Be ready to continue learning even without being prompted to do so, which can be further supported by the Advanced Clinical Research Project Manager Certification .

Great skills in organizing

Have great verbal and written communication skills

Additional certifications such as the Pharmacovigilance Certification , CRA , Advanced Principal Investigator Physician Certification , and Medical Monitor Certification are also beneficial for those looking to further their careers in clinical research.

7 Steps To Becoming A Clinical Research Coordinator

Understanding what clinical research organizations are and what they do.

Begin your journey with us – join our Early Career Talent Program! Apply today for Early Career Talent Program (Opens in new window)

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Clinical Research Coordinator Associate

Researchers are driven by possibility. As a Clinical Research Coordinator Associate, you will be a central force in our mission to ensure equity of care across the globe. With an opportunity to continue your professional development and interact with some of the top minds in medicine, your possibility-driven approach will have a profound impact on the lives of patients. As we work to make sure everyone has access to safe, innovative treatments, our NIH ranking and the backing of Stanford Medicine will help ensure that you have the resources you need to succeed. Join us at Stanford School of Medicine, where we are better with you.

• Level: Entry Level
• Travel: Minimal (if any)
• Salary: $63K-$96K

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Success Profile

What makes a successful Clinical Research Coordinator Associate at Stanford Medicine? Check out the traits we’re looking for and see if you have the right mix.

• Team Player
• Communicator
• Detail-Oriented
• Trustworthy

Career Path

• Assistant Clinical Research Coordinator leads to Clinical Research Coordinator Associate
• Clinical Research Coordinator Associate leads to Clinical Research Coordinator 2 or Medical Degree (MD) or Physician Assistant (PA) Program Medical Degree (MD) or Physician Assistant (PA) Program
• Clinical Research Coordinator 2 leads to Clinical Research Manager
• Clinical Research Manager

Employee Benefits

Comprehensive health and welfare benefits, unmatched time away benefits, unique education benefits, work-life programs, stanford sweeteners, job description.

The Department of Pediatrics, Division of Endocrinology is seeking a Clinical Research Coordinator Associate to perform duties related to the coordination of clinical studies. Coordinate moderately complex aspects of one or more clinical studies. Work under close direction of the principal investigator and/or study coordinator/supervisor.

Duties include:

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.
• Determine eligibility of and gather consent from study participants according to protocol. Assist in developing and implementing a variety of recruitment strategies.
• Coordinate collection of study specimens and processing.
• Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
• Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions and ensure institutional Review Board renewals are completed.
• Conduct study visits and semi-structured interviews, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
• Assist in coding qualitative interviews, data-cleaning, and participating in the coding process.
• Monitor expenditures and adherence to
• Participate in monitor visits and regulatory study budgets and resolve billing issues in collaboration with finance and/or management staff.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
• - Other duties may also be assigned

Stanford University provides pay ranges representing its good faith estimate of what the University reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs. The hourly range for this position working in the California Bay area is between $31.73 to $36.54 based on commensurate experience and background.

DESIRED QUALIFICATIONS:

• Stanford IRB Knowledge
• Assistant Clinical Research Coordinator experience

EDUCATION & EXPERIENCE (REQUIRED):

Two-year college degree and two years related work experience or a Bachelor’s degree in a related field or an equivalent combination of related education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

· Strong interpersonal skills.

· Proficiency with Microsoft Office.

· Knowledge of medical terminology.

· Previous use of RedCap (preferred not required)

CERTIFICATIONS & LICENSES:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

PHYSICAL REQUIREMENTS*:

· Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.

· Occasionally sit, reach above shoulders, perform desk-based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.

· Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORKING CONDITIONS:

· Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious disease and infections.

· May require extended or unusual work hours based on research requirements and business needs.

· Spanish speaking is preferred, as there will be monolingual Spanish participants in our studies.

~ All members of the Department of Pediatrics are engaged in continuous learning and improvement to foster a culture where diversity, equity, inclusion, and justice are central to all aspects of our work. The Department collectively and publicly commits to continuously promoting anti-racism and equity through its policies, programs, and practices at all levels. ~

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Why Stanford Medicine?

Stanford University has the unique benefit of being both well-established and intent on the future. As one of the most influential academic institutions in the world, our thought leaders, staff and cutting-edge, collaborative culture have fueled our belief in every possibility.

Testimonial

The pandemic has made it difficult for me to transition back into research. Once I started working at Stanford of Medicine, I immediately felt welcomed and supported. This institution has provided me with great opportunities to explore different kinds of research that can contribute to the field of precision medicine. It’s a great place for growth and to have my goals supported. –Guillermina Michel, Clinical Research Coordinator Associate – Anesthesia

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COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK

Clinical Research Coordinator

• Ophthalmology
• Columbia University Medical Center
• Opening on: Apr 23 2024
• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $62,400 - $65,000

Position Summary

Under the direction of the Director of the Clinical Trials Unit (CTU) and Principal Investigators, the Clinical Research Coordinator will conduct clinical research studies (industry-sponsored and investigator-initiated) within the Columbia University Irving Medical Center (CUIMC) Department of Ophthalmology in adherence with assigned study protocols and manuals of operation and in accordance with clinical research principles.

Responsibilities

• Serve as the contact person for those interested in study participation and assist with recruitment activities including pre-screening electronic medical records for eligibility, contacting potential subjects, explaining all study procedures, and consenting eligible subjects or assenting parents or guardians for children enrolled in research studies.
• Coordinate day-to-day aspects of study related procedures, including, but not limited to scheduling visits and procedures, data entry, preparing for research visits, research visit documentation, maintenance of regulatory binders and study files, creation and/or maintenance of source documentation, preparation for monitoring visits, site initiation/closeout visits and audits as needed.
• Be able to coordinate and perform research testing and imaging for clinical research studies including but not limited to visual acuity, refraction, dark adaptation, visual field, microperimetry, fluorescein angiography, fundus photography, optical coherence tomography (OCT), ICG angiography, slit lamp photography, MP1, corneal mapping, specular biomicroscopy including confocal imaging, HRT Analyzer (glaucoma), and ERGs.
• Be able to administer surveys, such as the National Eye Institute Vision Function Questionnaire (NEI-VFQ-25), EuroQOL-5 Dimension, Reading speed, Health Utilities Index.
• Work with the research team and ocular photography department to ensure that all required eye exams and ocular testing are scheduled and completed according to protocol.
• Obtain and maintain study certifications for ETDRS, OCT, and photography for clinical trials.
• Obtain access to sponsors’ electronic data capture (EDC) systems, complete EDC trainings, and enter data into the EDC within 5 days of seeing the study patient.
• Maintain and organize study-related documentation and records using the EDC platforms, including capturing adverse events and serious adverse events and preparing for monitoring visits.
• Respond to all sponsor-related queries in a timely manner.
• Ensure that all aspects of Good Clinical Practice are followed at all times by developing and ensuring adherence with Standard Operating Procedure (SOP) for clinical studies being conducted in the Ophthalmology Clinical Trials Unit.
• Work with the Regulatory Manager to gain CUIMC Institutional Review Board (IRB) approval in a timely manner by creating informed consent forms using sponsors’ templates, responding to IRB correspondents, submitting amendments, renewals, modifications, and other regulatory documents required by the sponsor and FDA, including progress reports.
• Ensure that all appropriate Institutional, State, and Federal regulations are followed throughout the course of the study according to study-related protocols and manuals.
• Work directly with sponsors’ designated Clinical Research Organizations (CRO) to complete all required study start-up documents including FDA 1572 forms, investigator signatures, CVs, medical licenses, Conflict of Interest, HIPAA, and Human Subjects Trainings in a timely manner.
• Complete feasibility forms requested by sponsors in a timely manner to assess ophthalmic equipment and examination rooms to conduct the studies.

Minimum Qualifications

• Bachelor’s degree or equivalent in education and experience, plus minimum of 1 to 2 years of related experience.
• Conform to all applicable HIPAA, billing compliance and safety requirements.
• Must be able to work effectively with minimal supervision.
• Prior research experience to include recruiting study participants, conducting standardized protocol visits and data entry.
• Excellent verbal and written communication skills and attention to detail required.
• Computer skills (Word, Excel) required.
• Excellent interpersonal skills.
• Willingness to travel to different sites.

Preferred Qualifications

• Working knowledge of Spanish
• Phlebotomy license
• Prior experience in ophthalmology

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.

Commitment to Diversity 

Columbia university is dedicated to increasing diversity in its workforce, its student body, and its educational programs. achieving continued academic excellence and creating a vibrant university community require nothing less. in fulfilling its mission to advance diversity at the university, columbia seeks to hire, retain, and promote exceptionally talented individuals from diverse backgrounds.  , share this job.

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Job Description for Clinical Research Coordinator

Clinical Research Coordinator organizes research information for clinical projects. Selects and observes subjects and assists with data analysis and reporting. Being a Clinical Research Coordinator oversees experiment scheduling and collection of data. Requires a high school diploma or equivalent. Additionally, Clinical Research Coordinator typically reports to a supervisor or manager. The Clinical Research Coordinator works under moderate supervision. Gaining or has attained full proficiency in a specific area of discipline. To be a Clinical Research Coordinator typically requires 1-3 years of related experience. (Copyright 2024 Salary.com)... View full job description

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About California

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