Regulatory Affairs Coordinator

A clinical research center is seeking a Regulatory Affairs Coordinator to support clinical trials by managing regulatory documentation and ensuring compliance with IRB, FDA, sponsor, and institutional requirements. The ideal candidate will have a bachelor's degree, at least three years of professional experience, and a minimum of one year of direct regulatory affairs experience creating and submitting IRB applications. This role is responsible for preparing IRB submissions, maintaining investigator site files, tracking regulatory approvals, and supporting study start-up through closeout. The coordinator will work closely with investigators, study coordinators, sponsors, and regulatory agencies to ensure timely and accurate submissions. Experience with clinical research regulations, GCP, and regulatory documentation management is required.

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Required Skills & Experience

Bachelor's degree required.
3 years of experience in a research environment
1 year of direct regulatory affairs experience supporting clinical research, including creating and submitting IRB applications and amendments.
Strong organizational skills with the ability to manage multiple deadlines simultaneously.
Excellent written and verbal communication skills.
Proficiency with Microsoft Office applications and electronic regulatory systems.
Ability to work independently and collaboratively in a fast-paced research environment.


Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.