Senior Regulatory Compliance Officer – Clinical Trials Office

The Ohio State University, Main Campus

Senior Regulatory Compliance Officer providing regulatory expertise for clinical trials compliance at Ohio State University. Overseeing research protocols and regulatory document reviews while training junior staff.

Posted 5/5/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

About the role

Key responsibilities & impact

Provides 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 oversight and monitoring of the regulatory research compliance function across all disease teams managed by the clinical trials office (CTO).
Serves as the subject matter expert for all regulatory compliance officers within the departments, reviews regulatory documents prior to submission to sponsors, IRB, FDA to ensure compliance.
Answers questions and provides technical support to junior members on the team.
Provides coverage/back up as needed for Regulatory manager and/or team members.
Manages complex submissions and assists junior team members with the process.
Participates in the development of SOPs and Processes for the regulatory team to stay current with the changing regulatory requirements and training.
Participates in the creation and delivery of onboarding and educational training programs, tools and materials for CTO staff, and investigators.
Provides regulatory guidance, direction and support to all members of the research team.
Stays current on legislation, rules, regulations, procedures, and development; educates physicians and staff regarding change as related to clinical research protocols, university staff, affiliates, and patients.
Works with CTO Managers and coordinators as needed to ensure understanding of study protocols.

Requirements

What you’ll need

Bachelor’s degree in relevant field required or equivalent combination of education and experience; Master’s degree in a relevant field desired;
clinical research certification from SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) required;
3 – 5 yrs. of experience in a clinical research or administrative capacity working on clinical research projects required;
considerable knowledge of clinical research regulations and compliance issues especially related to the use of human and animal subjects required;
experience and knowledge of federal & industry research sponsor requirements preferred;
experience in a regulatory affairs capacity in a medical research setting desired;
experience in protocol development desired.

Benefits

Comp & perks

Medical, dental and vision coverage, with Ohio State paying a significant portion of the cost.
Paid time off, including sick and vacation time and 11 holidays.
State retirement plan or an alternative retirement plan, both with generous employer contributions.

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory complianceclinical researchprotocol developmentSOP developmentsubmission managementtechnical supporteducational trainingmonitoringoversightresearch protocols

Soft Skills

communicationleadershipteam collaborationproblem-solvingorganizational skillsguidancedirectiontrainingsupportexpertise

Certifications

clinical research certificationSoCRA certificationACRP certification