Lead Regulatory Compliance Officer | Ccc - Clinical Trials Office

The Ohio State University

Remote, USA
Fully remote
Regulatory expertise
Clinical research protocols
Federal regulations
Serves as primary resource in regulatory aspects by providing regulatory expertise to assure research protocols are in compliance with university, state and federal regulations across research groups managed by the OSUCCC Clinical Trials Office

Job Summary

  • Serves as primary resource in regulatory aspects by providing regulatory expertise to assure research protocols are in compliance with university, state and federal regulations across research groups managed by the OSUCCC Clinical Trials Office.
  • Conducts interviews for regulatory staff and trains, mentors, and supervises staff.
  • Stays current on legislation, rules, regulations, procedures, and development; educate physicians and staff regarding change as related to clinical research protocols, university staff, affiliates, and patients.

Matching Summary

Serves as primary resource in regulatory aspects by providing regulatory expertise to assure research protocols are in compliance with university, state and federal regulations across research groups managed by the OSUCCC Clinical Trials Office.

Skills & Requirements

Must-have

  • regulatory expertise
  • clinical research protocols
  • federal regulations
  • IRB compliance
  • FDA regulations
  • sponsor regulations

Nice-to-have

  • mentoring junior staff
  • external audit lead
  • SOP development
  • training program creation
  • investigator guidance

Key Requirements

  • Bachelor’s Degree or equivalent experience
  • Master’s degree desired
  • SoCRA or ACRP certification required
  • 3-5 years clinical research experience
  • Knowledge of clinical research regulations
  • Experience with federal & industry sponsor requirements preferred
  • Experience in regulatory affairs desired

Work Rights

Not specified

Tailored Resume

Cover Letter