Senior Regulatory Compliance Officer - Clinical Trials Office

20h20 hours ago

The Ohio State University

US · Full-time · $85,000 – $115,000

About this role

The Senior Regulatory Compliance Officer for Investigator-Initiated Trials provides regulatory expertise to assure research protocols comply with university, state and federal regulations. This position manages regulatory affairs for investigator-initiated oncology clinical trials during study start-up across groups managed by the OSUCCC Clinical Trials Office.

Daily work includes assisting the Regulatory Manager with oversight of compliance functions across all disease teams. The officer serves as subject matter expert, reviews regulatory documents prior to sponsor, IRB or FDA submission, and manages complex submissions while supporting junior team members.

The role requires close collaboration with investigators, CTO managers and coordinators to ensure protocol understanding and appropriate regulatory safeguards. Participation in SOP development, onboarding programs and ongoing education for staff and investigators keeps the team current with changing requirements.

Staying current on legislation, rules and procedures allows the officer to educate physicians, staff and affiliates on updates affecting clinical research protocols. This senior position offers opportunities to shape regulatory processes and provide technical leadership within a specialized oncology clinical trials environment.

Requirements

Subject matter expertise in regulatory compliance for investigator-initiated oncology clinical trials.
Experience preparing and submitting INDs, IDEs, protocol submissions and annual reports to FDA and IRB.
Strong knowledge of university, state and federal regulations governing clinical research.
Ability to review and evaluate protocols and informed consent forms prior to FDA/IRB review.
Experience developing SOPs and delivering regulatory training to research staff and investigators.
Proven ability to manage complex regulatory submissions and support junior compliance staff.

Responsibilities

Assists the Regulatory Manager with oversight and monitoring of regulatory research compliance across all disease teams managed by the Clinical Trials Office.
Serves as subject matter expert for regulatory compliance officers, reviewing documents prior to submission to sponsors, IRB and FDA.
Provides technical support and coverage for junior team members and Regulatory Manager as needed.
Manages complex submissions and assists junior team members with the regulatory process.
Participates in development of SOPs and processes to maintain compliance with changing regulatory requirements.
Creates and delivers onboarding and educational training programs for CTO staff and investigators.
Reviews, evaluates and compiles files for initial INDs, IDEs, protocol submissions and annual reports.
Collaborates with investigators during study development to confirm appropriate regulatory safeguards.