Regulatory Coordinator
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About The Position
The Regulatory Coordinator completes and maintains regulatory documents for clinical trials to ensure protocol, regulatory and Standard Operating Procedures (SOP's) and Good Clinical Practice (GCP) compliance. They will assist the Manager and Supervisor of the unit and train coordinating staff as delegated by the manager. The position requires strong written communications skills, attention to detail, ability to meet multiple and changing deadlines, the ability to interact with a variety of people and to consult numerous sources for information for preparation of documents and assist with responses to IRB and sponsor questions that are compatible with numerous policies and procedures. This position is also responsible for maintaining regulatory compliance guidelines for each trial and educating CERU staff in sponsor guidelines. The incumbent must be able to work in a very busy interactive environment with frequent interruptions and to perform tasks accurately in a timely fashion. This position will also include study coordinator duties as time permits which would involve recruiting, screening, assisting in determining eligibility, enrolling study participants, and conducting with a strong focus on teamwork.
