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Regulatory Coordinator – A Day in the Life

Regulatory Coordinator - Regulatory Coordinators are primarily responsible for ensuring that the clinical trial is adhering to the protocol and guaranteeing ethical conduct.

I wanted to make a blog post about a week in my life, but realized that 40 hours of my weeks are taken up by my day job as a Clinical Research Coordinator (CRC). In order to write that post, I have to explain what a CRC is and does. CRCs are the guardians of clinical research trials. The overall goal is to ensure that informed consent is appropriately obtained and that a study is run in compliance with the protocol, and good clinical practices (GCPs). Typically CRC performs the duties of both Study Coordinators and Regulatory Coordinator, but my job is more specialized as I am only the Regulatory Coordinator.

What is a Regulatory Coordinator?

Regulatory Coordinators are primarily responsible for ensuring that the clinical trial is adhering to the protocol and guaranteeing ethical conduct which includes protecting human subjects’ rights, compliance, and following the state and federal guidelines and regulations. Mostly, I am the person that makes sure that the clinical trials follow the rules. That the research staff doesn’t initially endanger subjects as well as submitting protocol amendments, continuing reviews and maintaining the regulatory binders.

My day can vary wildly, and even though I will walk into the office with a plan for the day, a simple email or phone call can completely stop all preconceived notions of that day. As a result, I try to keep my days pretty organized to the best of my ability. Currently, I am working four 10 hour days where my day starts at 7 am and ends at 530pm. Also, as work on Oncology Clinical Trials, my days tend to be busier than the average CRC. Here is a sample day may look like to me.

What does a typical day look like?

650a: Arrive at work. Start up the computer, and get ready for the day. Typically, I prepare my early morning snack (I eat a small breakfast at home), and put my lunch in the fridge.

7am-8am: Depending on the day, I complete continuing reviews, PRMC submissions, and prepare folders to be sent out for signatures. Also, I go through my emails and organize the things I will tackle for the day.

9am-12am: Meetings (depending), training mentees and new staff, and orientation. Tumor board meetings, disciplinary meetings, working on the initial submission, protocol and IB amendments.

1230am-1pm: Lunch. Typically I eat lunch for 15 mins and walk for 15 mins. Sometimes, I eat and talk with the co-workers.

1pm-4pm: Review emails again! Complete consent revisions, train some new staff, update regulatory documents. File correspondence, and other documents, perform some administrative duties such as complete spreadsheets, and other documents.

4-530pm: Complete my todo list for the next day. Process IRB approvals, enter IRB submissions into the database, send out training information. Organize my desk, and review projects/assignments given to the data entry techs and student assistants.

As I said before, my day can dramatically change once I open a single email or receive a single phone call. Despite that, I tend to keep my early morning, and late evening essentially standard.  As a result of the variation of the day to day, people that are not highly organized and easily stressed tend to burn out fairly quickly. Hopefully, this article helps in the understanding of what a CRC is and does.

Note – Recently I have switched companies and positions. While I am still primarily in charge of regulatory, I deal with a variety of other tasks related to the whole spectrum of clinical research.

For additional information about Clinical Trials or Becoming a Clinical Research Coordinator, check out the following links:

Clinical Trials – What Patients Need to Know
Clinical Trials – Database
SOCRA – What is a CRA?

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Regulatory Coordinator - Regulatory Coordinators are primarily responsible for ensuring that the clinical trial is adhering to the protocol and guaranteeing ethical conduct.
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