Lead Regulatory Compliance Officer | Ccc - Clinical Trials Office

The Ohio State University

Unknown, Unknown, 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 junior staff
  • external audit lead
  • onboarding training programs
  • educate physicians and staff

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 human and animal subjects

Work Rights

Not specified

Tailored Resume

Cover Letter