Lead Regulatory Compliance Officer | Ccc - Clinical Trials Office

The Ohio State University

Remote, US
Fully remote
Regulatory expertise
Clinical research protocols
Federal regulations
Lead Regulatory Compliance Officer 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

  • Lead Regulatory Compliance Officer 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

Lead Regulatory Compliance Officer 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
  • SOP development

Nice-to-have

  • mentoring staff
  • external audit lead
  • onboarding training
  • physician education

Key Requirements

  • Bachelor’s Degree in biological sciences, health sciences, social sciences or other medical field or equivalent
  • Master’s degree in a relevant field desired
  • Clinical research certification from SoCRA or ACRP required
  • Three to five years of experience in clinical research
  • Knowledge of clinical research regulations and compliance issues
  • Experience with human and animal subjects

Work Rights

Not specified

Tailored Resume

Cover Letter