Regulatory Operations Associate

Company: Zachary Piper Solutions, LLC
Location: Bethesda
Posted on: May 3, 2021

Job Description:

Piper Clinical Solutions is looking for a motivated Regulatory Operations Associate to join a Research Organization's team in Bethesda, MD. The Regulatory Operations Associate will be in charge of following protocols to support clinical trials. Responsibilities for the Regulatory Operations Associate bull assemble standard documentation aiding regulatory filings bull sustain files for regulatory documents accepting trial master files bull Manage electronic databases for clinical trials in preparation of audits bull Manage Standard Operating Procedures, templates, and Work Instructions bull follow regulatory activity, manage databases, and assure that records are finished bull Administrative support Requirements for the Regulatory Operations Associate bull Understanding of Good Clinical Practice (Google Cloud Platform) andor experience with regulated clinical trial environment submissions (FDA, IRB, IND) bull Experience with preparation of documents for electronic submission and utilizing electronic filing software (eIRB) a plus bull Master's Degree in Science Related field Compensation for the Regulatory Operations Associate bull Annual salary up to 52,000 based on meeting of requirements bull Benefits Health, Dental, Vision insurance and 401K

Keywords: Zachary Piper Solutions, LLC, Bethesda , Regulatory Operations Associate, Other , Bethesda, Maryland