Senior Regulatory Compliance Officer – Clinical Trials

The Ohio State University, Main Campus

. Provide regulatory expertise to ensure research protocols comply with university, state, and federal regulations .

Posted 9/17/2026full-timeColumbus • Ohio • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory compliance for clinical research, including the development and review of protocols, informed consent forms, and regulatory submissions. Proficient in collaborating with research teams and managing compliance across various stakeholders in accordance with federal and state regulations.

Highest-signal resume keywords

Regulatory Compliance ExpertiseClinical Research CertificationProtocol DevelopmentRegulatory Affairs ExperienceKnowledge of Clinical Research Regulations

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsSOP DevelopmentIND ReviewIDE ReviewData CompilationRegulatory GuidanceDocument ReviewClinical Protocol DocumentationRegulatory AnalysisCompliance Monitoring

Soft Skills

CommunicationCollaborationTechnical SupportMentoring

Certifications & Qualifications

Clinical Research Certification from SoCRAClinical Research Certification from ACRP

Industry Keywords

Clinical TrialsFDA RegulationsIRB SubmissionResearch ProtocolsHuman Subjects ComplianceAnimal Subjects ComplianceResearch Sponsor Requirements

About the role

Key responsibilities & impact

Provide regulatory expertise to ensure research protocols comply with university, state, and federal regulations
Oversee and monitor regulatory research compliance across disease teams managed by the Clinical Trials Office
Serve as subject matter expert for regulatory compliance officers and review documents before sponsor, IRB, and FDA submission
Provide technical support and backup coverage to junior team members, the Regulatory Manager, and team members
Manage complex regulatory submissions and assist junior team members
Develop SOPs, processes, onboarding programs, educational training, tools, and materials
Provide regulatory guidance and support to research teams, physicians, staff, affiliates, and patients
Review and compile files and reports for INDs, IDEs, protocol submissions, and annual reports
Collaborate with investigators during study development to ensure appropriate regulatory safeguards
Review protocols and informed consent forms before FDA and IRB review
Communicate with academic, federal, and industry sponsors to ensure compliance
Coordinate with internal and external entities and compile data relevant to clinical trials
Develop FDA submission packets, submit standard forms, and draft informed consent forms
Review technical and clinical protocol documentation and recommend regulatory compliance changes
Research and analyze regulatory information and assess the acceptability of data, procedures, and product-related documentation for registrations

Requirements

What you’ll need

Bachelor’s degree in relevant field required or equivalent combination of education and experience
Clinical research certification from SoCRA or ACRP required
3–5 years 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 human and animal subjects
Experience and knowledge of federal and industry research sponsor requirements preferred
Experience in regulatory affairs in a medical research setting desired
Experience in protocol development desired
Master’s degree in a relevant field desired
Successful completion of a background check required for final candidates
Drug screen or physical may be required during the post-offer process

Benefits

Comp & perks

Regular position
First shift
Primarily remote work arrangement
In-person training sessions and orientation during onboarding
Occasional in-person meetings, audits, monitoring visits, and site initiation visits after onboarding