Regulatory Affairs Specialist

Required Skills & Experience

Bachelor's degree required.\n3 years of experience in a clinical research environment\nDirect regulatory affairs experience supporting clinical research, including creating and submitting IRB applications and amendments.\nStrong organizational skills with the ability to manage multiple deadlines simultaneously.\nExcellent written and verbal communication skills.\nProficiency with Microsoft Office applications and electronic regulatory systems.\nAbility to work independently and collaboratively in a fast-paced research environment.

Job Description

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.