Lead Regulatory Compliance Officer | Ccc - Clinical Trials Office
The Ohio State University
Remote, US
Fully remote
Regulatory expertise
Clinical research compliance
Fda regulations
The Ohio State University is seeking a Lead Regulatory Compliance Officer for its Clinical Trials Office, who will provide regulatory expertise to ensure compliance with various regulations in clinical research. The role involves oversight of the regulatory team, training staff, and serving as a key contact for audits and compliance inquiries
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 its Clinical Trials Office, who will provide regulatory expertise to ensure compliance with various regulations in clinical research. The role involves oversight of the regulatory team, training staff, and serving as a key contact for audits and compliance inquiries.
Skills & Requirements
Must-have
regulatory expertise
clinical research compliance
FDA regulations
IRB compliance
federal and state regulations
Nice-to-have
mentoring junior staff
external audit lead
SOP development
onboarding and training programs
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 or administrative capacity
Knowledge of clinical research regulations and compliance issues
Experience in a regulatory affairs capacity desired