Clinical Research Coordinator (CRC) Career in Managing Research Trials

A Clinical Research Coordinator (CRC) is a career in managing research trials.

A "Clinical Research Coordinator" (CRC) is also called a "Study Coordinator" (SC).  The terms are used with equal frequency.  Most people say "Study Coordinator" since it is shorter; however, the Association of Clinical Research Professionals (ACRP) provides a certified CRC certificate.

ACRP defines the CRC role as:
"A CRC works at a clinical research site, with study subjects, under the immediate direction of a principal investigator, whose research activities are conducted under GCP guidelines."

But what does this job description mean?

A clinical research site is a place where is "clinical trial" is conducted.  (If you are unsure what a clinical trial is then read this blog post.)  A Sponsor (drug, device, biotech) of a trial will find medical clinics to offer an "Investigational Product" (IP).  A clinic will enroll patients into a clinical trial.  Once a patient decides to participate in a trial then the person is referred to as a study "subject".  There is at least one physician (or someone of appropriate training) who will oversee the trial at the trial at the clinic called the "Principal Investigator" (PI). (To learn more about study roles, read this blog post.)  The PI will provide guidance to the CRC, but the CRC mainly works independently to manage the clinical trial at the site.  The word "GCP" refers to "Good Clinical Practice".  It is a set a guidelines (country specific) on how a clinical trial should be conducted.

Some of the responsibilities of a CRC with patients/ study subjects include:

• Performing a chart review on clinic patients to see if any potentially qualify for the study.  If they do then call the patient to see if they want to come in for the study.
• If the PI has a patient in the office for a clinic visit who is interested in the study then the CRC will help explain the study and required office visits/ procedures to the potential subject.
• If the site is advertising the study, then the CRC may discuss the study with people who are not regular patients of the clinic but want to participate in the study.
• If a patient is interested in enrolling in the study, the the CRC will review a document called the "Informed Consent Form" (ICF).  This document explains in writing the study procedures, risks, safety information, and rights of a study subject.
• Once a patient becomes  study subject, the CRC will coordinate the office visits, as well as, follow-up contacts between visits.  The CRC is often the main person that works with the study subject during the clinical trial.
• At office visits, the CRC will ask a subject about past medical history, take vital signs, draw labs samples (if needed), administer questionnaires, and give instructions to the subject on how to comply with the study protocol requirements.  The CRC will ensure the PI meets with the subject as needed and updates the PI on the subject's health and status. 
• Between office visits, the CRC will contact the subject to give reminders about study visits, ask about the subject's health, and answer study questions.
• The CRC records all their subject interactions in records called "source documents".  A source document is considered the first place a piece of data is written and could be a piece of paper, an x-ray, or captured directly in an electronic medical record (EMR).
• The CRC will take the source document data and transfer it to a "Case Report Form" (CRF).  This is a data form that will transmit the study data (questionnaire answers, vital signs, physical exam results) to the Sponsor.  The reason it needs the study data needs to be entered into a CRF is so that it removes "personal health information" (PHI) that would allow a subject's identity (name, address, local medical records numbers) to become known to the sponsor. 

A CRC also works with Sponsor or Contract Research Organization (CRO) staff.  Here are some of those responsibilities:

• The Sponsor/ CRO matching role can be considered to be the "Clinical Research Associate" (CRA) which is also called the "Monitor".  The CRA acts a study liaison with the site providing study updates.  The CRA will occasionally visit the site for training or to review data.  Between office visits, the CRA will contact the CRC to provide study information and ask certain study tasks be completed.
• The CRA will compare the source documentation to the CRF during the visits.  If the source data conflicts or is missing in the CRF, then the CRA asks the CRC to resolve or clarify the issue.  CRAs are not allowed to change data.  They can only review it.  The CRA will give the CRC a "data clarification form" (DCF) also known as a "query".  
• Once the CRF data is transmitted to the Sponsor or CRO, many other staff will look at it and may also issue DCFs too.

The CRC works with an independent Ethics Committee (EC) or Institutional Review Board (IRB). (IRB is the term used in the United States and EC is used by the rest of the world.) The EC/IRB is a group (per local country guidelines) that oversees the trial.  Responsibilities of reporting to the EC/IRB include:

• Completing the initial application and obtaining approval to have open the clinical trial at the site.
• Answering questions that the EC/IRB may have about the study.
• Providing updates to the EC/IRB on the study's progress including safety updates and any significant site errors or problems with the study.
• Notifying the EC/IRB once the study is complete.

There are additional responsibilities than those noted above, but this is a general guideline.  The PI is also overseeing and is responsible for the CRC's work throughout the trial.  Larger clinics break up the CRC's responsibilities such as having one staff focus on recruitment, one person for processing and shipping lab samples, and another for handling all EC/IRB communications and regulatory documents.

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