Lead Regulatory Compliance Officer | Ccc - Clinical Trials Office

The Ohio State University

Remote, US
Fully remote
Regulatory expertise
Clinical research regulations
Fda 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.
  • Assists the Regulatory Manager with the daily oversight of the Regulatory team and monitoring of the regulatory research compliance function across all disease teams managed by the Clinical Trials Office (CTO).
  • 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 regulations
  • FDA regulations
  • IRB compliance
  • external audit lead

Nice-to-have

  • mentoring junior staff
  • SOP development
  • onboarding and training programs
  • physician and staff education

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 human and animal subject regulations

Work Rights

Not specified

Tailored Resume

Cover Letter