Lead Regulatory Compliance Officer | Ccc - Clinical Trials Office

The Ohio State University

Remote, ,
Fully remote
Regulatory expertise
Clinical research protocols
Federal regulations
The Ohio State University is seeking a Lead Regulatory Compliance Officer for their Clinical Trials Office, responsible for ensuring compliance with regulatory standards in clinical research. The role requires a strong background in clinical research regulations, oversight of a regulatory team, and collaboration with various stakeholders

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

Match Score: 85

The Ohio State University is seeking a Lead Regulatory Compliance Officer for their Clinical Trials Office, responsible for ensuring compliance with regulatory standards in clinical research. The role requires a strong background in clinical research regulations, oversight of a regulatory team, and collaboration with various stakeholders.

Skills & Requirements

Must-have

  • regulatory expertise
  • clinical research protocols
  • federal regulations
  • IRB compliance
  • FDA regulations
  • external audits

Nice-to-have

  • mentoring junior staff
  • SOP development
  • 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

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