Regulatory Coordinator

University of Tennessee Medical Center at Knoxville, United States

Updated: 3 months ago
Location: Knoxville, TENNESSEE

Job Detail
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  • Job Title: Regulatory Coordinator
  • Department: Office of Clinical Trials
  • Full/Part Time: Full
  • Req Number: UHS-30208

Position Summary:

Prepares, submits and maintains clinical trials regulatory data and documents. Initiates and maintains all Regulatory documents necessary for submission to Institutional Review Boards, study sponsors, and various agencies in order to obtain initial and continued approval of all clinical trials. This position functions as an integral part of a project team whose objective is to assist study sponsors, physicians, and patients enroll and complete clinical research trials. This position is responsible for all regulatory document coordination, filing, monitoring and reporting to the project team regarding regulatory information. The Regulatory Coordinator also receives, processes, distributes, and manages clinical trial safety reporting.


Position Qualification:

Required:

1-3 years experience in clinical, research, and/or regulatory support role.

-Proficient in Microsoft Word, Excel, e-mail and other commonly used computer software.

Preferred experience:
-Familiarity with general human anatomy knowledge and familiarity with medical terminology.
-Familiarity with clinical trials regulatory guidelines and requirements.



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