What does a Clinical Research Coordinator (CRC) do?

From my personal experience working as a Clinical Research Coordinator (CRC), I can confirm that CRCs are the backbone of clinical research. They are also sometimes known as a Study Coordinator. Their role varies slightly based on how big the study team is and how big the organization they work for is. Other variable factors include the therapeutic area they work in. A CRC working in Oncology research might have a completely day-to-day work schedule compared to someone working in respiratory.

In this blog, I’m going to talk about what a CRC’s role looks like from a general standpoint.

Following are some of the main job responsibilities of a CRC:

1. Oversee daily functions of clinical trials from inception to close-out.
2. Work closely with the Principal Investigator (PI), study staff, cross-functional teams (quality assurance, regulatory, legal, and operations), patients, sponsors, CROs, IRB (or equivalent ethics board).
3. Must comply with all regulatory regulations and guidelines of FDA, ICH-GCP, IRB, study protocols, and any internal standard of practices that apply to a CRC role.
4. Work closely with supervisors, study staff, and cross-functional teams to complete any feasibility questionnaires.
5. Responsible for patient recruitment including submitting any advertising for sponsor and IRB approval as well as keeping track of any recruitment efforts and screening.
6. Obtain informed consent under the guidance of the PI and ensure that the patient fully comprehends the study requirements before agreeing to participate.
7. Ensure subjects meet all inclusion and exclusion criteria of the study and have been properly consented before screening and enrollment.
8. Work with cross-functional teams in the creation of source document templates to ensure a smooth process during enrollment.
9. Coordinate, respond, and manage study data and ensure everything that is entered is accurate and maintains the integrity of the study.
10. Complete case report forms (CRFs) and respond to all internal and external queries on time.
11. Manage and ensure site staff is fully trained before the study is conducted.
12. Maintain a record of all receipts, storage, shipments, and correspondence.
13. Manage study binders to ensure all documents of the clinical trial are organized for easy access.
14. Attend all clinical trial visits (PSSVs, SIVs, IMVs, COVs, and more).
15. Communicate and stay on top of everything related to IRBs, sponsors, CROs, and outside vendors.
16. Participate in regular team calls to review the status of current clinical research projects and discuss any needs.

Additional Information:

These typically apply to small to medium-sized organizations. Smaller study teams can apply to big organizations as well. If the site has a bigger team, many of these tasks are delegated to the study team. Often, the study teams are bigger for therapeutic areas like oncology or rare disease studies as the stakes are higher. Some CRCs work hybrid while others work 8-10 hours, 5 days a week. Just remember, patient safety is above everything!

I hope this post helped you understand the ins and outs of a CRC role!