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:

• assemble standard documentation aiding regulatory filings

• sustain files for regulatory documents accepting trial master files

• Manage electronic databases for clinical trials in preparation of audits

• Manage Standard Operating Procedures, templates, and Work Instructions

• follow regulatory activity, manage databases, and assure that records are finished

• Administrative support

Requirements for the Regulatory Operations Associate:

• Understanding of Good Clinical Practice (Google Cloud Platform) and/or experience with regulated clinical trial environment & submissions (FDA, IRB, IND)

• Experience with preparation of documents for electronic submission and utilizing electronic filing software (eIRB) a plus

• Master’s Degree in Science Related field

Compensation for the Regulatory Operations Associate:

• Annual salary up to $52,000 based on meeting of requirements

• Benefits: Health, Dental, & Vision insurance and 401K – provided by DiceTracking



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