Lead Regulatory Compliance Officer | Ccc - Clinical Trials Office

cspam.osu.edu

Fully remote
Regulatory compliance expertise
Clinical research protocol oversight
Supervision and mentoring of staff
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.
  • The role involves assisting the Regulatory Manager with oversight of the Regulatory team, conducting interviews, training and mentoring staff, and serving as the subject matter expert for regulatory compliance officers.
  • The position requires staying current on legislation and regulations, providing regulatory guidance to research teams, and participating in the development and delivery of onboarding and educational training programs.

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 compliance expertise
  • Clinical research protocol oversight
  • Supervision and mentoring of staff
  • Knowledge of IRB and FDA regulations
  • External audit coordination
  • Development of SOPs and training materials

Nice-to-have

  • Experience in regulatory affairs
  • Protocol development experience
  • Training and educational program delivery
  • Collaboration with clinical trial managers

Key Requirements

  • Bachelor’s Degree in biological, health or social sciences or equivalent
  • Master’s degree desired
  • Clinical research certification from SoCRA or ACRP required
  • Three to five years clinical research experience
  • Knowledge of clinical research regulations and compliance
  • Experience with federal and industry sponsor requirements preferred

Work Rights

Not specified

Tailored Resume

Cover Letter