Regulatory Compliance Assistant

The Ohio State University
8dHybrid

About The Position

Regulatory Compliance Assistant to provide support to assure research protocols are in compliance with university, state and federal regulations across research groups managed by the College of Medicine’s Center for Clinical Research Management (CCRM); assists with regulatory functions in support of clinical research activity; assists in preparation of protocol submissions to Institutional Review Boards (IRBs) and provides updates on submission status; assists in preparation of other required regulatory documents; distributes approved documents; relays information to clinical research staff; assists with data entry including collecting, entering and maintaining data and documents in the OnCore electronic database and e-Regulatory; assists with monitoring visits; assists with regulatory issues; creates and maintains regulatory files.

Requirements

  • Minimum Education Required High School diploma or GED. Certification or vocational training may be preferred.
  • 1 year of relevant experience required.
  • Requires successful completion of a background check.
  • Selected candidate may be requested to complete a pre-employment physical including a drug screen.

Nice To Haves

  • Bachelor's degree, preferably in biological sciences, health sciences, or life sciences
  • 2-4 years of relevant experience preferred.
  • Experience in a clinical research capacity desired
  • computer skills required with knowledge of database software applications desired

Responsibilities

  • assure research protocols are in compliance with university, state and federal regulations
  • assists with regulatory functions in support of clinical research activity
  • assists in preparation of protocol submissions to Institutional Review Boards (IRBs) and provides updates on submission status
  • assists in preparation of other required regulatory documents
  • distributes approved documents
  • relays information to clinical research staff
  • assists with data entry including collecting, entering and maintaining data and documents in the OnCore electronic database and e-Regulatory
  • assists with monitoring visits
  • assists with regulatory issues
  • creates and maintains regulatory files

Benefits

  • Eligible Ohio State employees receive comprehensive benefits packages, including medical, dental and vision insurance, tuition assistance for employees and their dependents, and state or alternative retirement options with competitive employer contributions.
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