Difference between clinical research associate and coordinator:

A clinical research associate (CRA), also called a clinical monitor or trial monitor, is a research professional with a minimum of a bachelors degree (usually nurses!) who works under contracts or hired by sponsors, CROs, or freelancing (by biopharma and research institutes) to perform roles listed in ICH GCP guidelines for monitoring clinical trials.

A CRA ensures compliance with ICH GCP and the clinical trial protocol by checking clinical site activities, making on-site visits (selection, initiation, routine, close-out), verifying “trial” case report forms (CRFs) are accurate by comparing to medical records, and speaking with the site’s CRC.

CRAs protect the ethical safety of human subjects and ensure the scientific integrity of the data collected through these processes.

Difference between clinical research coordinator and clinical research associate:

When a PI (principal investigator, i.e. often a busy, working physician running a trial on the side) is chosen to conduct a trial at their site, clinical research coordinators often take over part of the essential responsibilities of PI. This includes making sure the trial is 1) conducted and 2) in compliance with the protocol and federal or international regulations.

CRC vs CRA: CRC responsibilities include writing the IRB/Ethics Committee application (specific to each site unless trial is under a single IRB/sIRB), making/performing informed consent (IC) process, developing a budget for the site, subject recruitment, patient care, adverse event reporting (a CRA simply audits and ensures that no AEs were missed!), preparing the case report form (CRF) for the CRA to review against medical records, and submitting tons of data and records to the CRA/Sponsor at each site visit.

Clinical Research Associate vs Coordinator Salary

Because CRAs manage multiple trial sites at one time, have a bachelors degree (minimum), and produce outcomes that are cost-effective for improving the efficiency of a trial; clinical research associates usually get paid more than coordinators. Unfortunately, clinical research coordinators are really doing the brunt of the “front-line” work and are the reason the trial occurs at that site all together. CRCs take a huge responsibility in both starting the trial and then presenting the trial documents to the CRAs as well as being the “middle-man” of the entire Site vs. Sponsor/CRO communication line. While CRCs deserve to get paid more, of course, it is not cost-effective as there are usually multiple sites and thus budgets are not capable of expanding upon the CRC’s pay-range. Luckily, CRC’s with experience can bridge to becoming a CRA through certifications and exams.

List of Relevant Courses:

• Clinical Research Coordinator Certification: Enroll Here

• Pharmacovigilance Certification: Enroll Here

• Clinical Research Associate (CRA) Certification: Enroll Here

• ICH-GCP Certification: Enroll Here

• Clinical Trials Assistant Training: Enroll Here

• Advanced Clinical Research Project Manager Certification: Enroll Here

• Advanced Principal Investigator Physician Certification: Enroll Here

• Medical Monitor Certification: Enroll Here

CRC to CRA bridge program

You can bridge into being a CRA in your own company or apply for jobs to be a CRA by completing CRA certification and trying to get experience with any on-site “in house” CRAs your site may have. CCRPS provides advanced “senior”-level CRA certification for CRCs so that:

1) on resumes you can prove knowledge competency of CRA tasks up to an advanced level (easier for in-job promotion)

2) during interviews you can prove your application of knowledge

3) during the job itself you can be efficient and diligent in preventing errors.