Regulatory Operations Associate
Company: Zachary Piper Solutions, LLC
Location: Rockville
Posted on: November 18, 2020
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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, Rockville , Regulatory Operations Associate, Other , Rockville, Maryland
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