Regulatory Compliance Officer – Cancer Trials

The Ohio State University, Main Campus

. Assure that OSUCCC Clinical Trials Office research protocols comply with University, state and federal regulations .

Posted 11/4/2026full-timeColumbus • Ohio • United StatesJuniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory compliance and protocol management within clinical trials, including the development of informed consent documents and IRB submissions. Strong collaboration skills with investigators and regulatory agencies ensure adherence to federal and state regulations.

Highest-signal resume keywords

Regulatory ComplianceIRB Submission DevelopmentResearch Regulations KnowledgeInformed Consent Document PreparationCollaboration with Investigators

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Protocol ReviewRegulatory Document PreparationData CompilationProtocol Tracking SystemsAmendment DistributionAudit ParticipationResearch Project ExperienceCompliance Issue KnowledgeFederal Regulations MonitoringStudy Material Dissemination

Soft Skills

CommunicationCollaborationOrganizational SkillsAttention to DetailProblem-Solving

Certifications & Qualifications

Bachelor’s Degree in Biological SciencesBachelor’s Degree in Health SciencesBachelor’s Degree in Social Sciences

Industry Keywords

Clinical TrialsIRBFDAResearch ProtocolsCompliance GuidelinesResearch ProjectsRegulatory AgenciesFederal RegulationsSponsor ProcessesBackground Check

About the role

Key responsibilities & impact

Assure that OSUCCC Clinical Trials Office research protocols comply with University, state and federal regulations
Ensure timely submission of paperwork to appropriate reviewing agencies
Collaborate with investigators during study development to confirm appropriate regulatory safeguards
Review assigned protocols and informed consent forms before IRB review
Communicate with academic, federal, and industry sponsors to ensure compliance
Coordinate with internal and external entities and compile data relevant to CTO trials
Develop IRB submission packets, including abstracts, standard forms, and informed consent forms
Maintain protocol review tracking systems and regulatory essential files
Review protocol revisions and amendments and determine whether IRB review is required
Distribute amendments and IRB-approved informed consent forms to relevant protocol holders
Serve as the main contact for dissemination of approved study materials
Attend meetings and serve as CTO contact with regulatory agencies, including the FDA and IRBs
Monitor federal and sponsor rules and identify new or changed requirements
Provide regulatory updates and guidance to investigators and research staff
Participate in audits and site visits

Requirements

What you’ll need

Bachelor’s Degree in biological sciences, health sciences, social sciences or other medical field, or an equivalent combination of education and experience required
1 year experience in research or administrative capacity working on research projects
Knowledge of research regulations, guidelines and compliance issues required
Experience developing informed consent documents and preparing regulatory documents desired
Experience and knowledge of IRB and federal or industry sponsor processes and requirements preferred
The university will not sponsor work visas for this position
Successful completion of a background check required for final candidates
A drug screen or physical may be required during the post-offer process

Benefits

Comp & perks

Regular position
First shift
40 scheduled hours
Primarily remote work after onboarding
In-person training sessions and orientation during onboarding
Occasional in-person meetings, audits, monitoring visits, and site initiation visits
Equal opportunity employer, including veterans and disability