Research Compliance Officer- Center for Clinical Research Management

The Ohio State University

1d • Hybrid

About The Position

The Center for Clinical Research Management (CCRM) at The Ohio State University is seeking a Regulatory Compliance Officer. This role provides regulatory expertise to ensure research protocols comply with university, state, and federal regulations across research groups managed by CCRM. The officer will participate in developing and implementing strategies, policies, and procedures to ensure proposals meet or exceed federal, state, and local regulations. Responsibilities include developing and preparing protocol submissions to local and national Institutional Review Boards (IRB), writing abstracts, submitting standard forms, and drafting informed consent forms. The role involves collaborating with investigators during study development to confirm appropriate regulatory safeguards, conducting detailed reviews of assigned protocols and informed consent forms prior to IRB review, and ensuring timely submission of protocol documents for review by the appropriate agency. The officer will communicate with sponsors of research projects to address concerns and assure compliance, establish and oversee a tracking system for protocol review progress and approval status, and review and authorize protocol revisions and amendments. They will also amend consent forms as needed, following established guidelines from OSU and NIH to determine if an amendment requires IRB review, and distribute amendments and IRB-approved informed consent forms to relevant university protocol holders. Continuous monitoring of federal and sponsor rules, regulations, and processes to identify and interpret new, updated, or changed requirements is essential. The role includes providing regulatory updates to investigators and research staff and participating in audits and site visits.

Requirements

• Bachelor’s Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required.
• 2 years of relative experience in research or administrative capacity working on research projects required.
• Knowledge of research regulations, guidelines and compliance issues required.
• Requires successful completion of a background check.

Nice To Haves

• 2-4 years of relevant experience preferred.
• Experience developing informed consent documents and preparing regulatory documents desired.
• Experience and knowledge of IRB and federal or industry sponsor processes and requirements preferred.
• Selected candidate may be requested to complete a pre-employment physical including a drug screen.

Responsibilities

• Provides regulatory expertise to assure research protocols are in compliance with university, state and federal regulations across research groups managed by the College of Medicine Center for Clinical Research Management (CCRM).
• Participates in development and implementation of strategies, policies and procedures to ensure proposals meet or exceed federal, state and local regulations.
• Develops and prepares protocol submissions to local and national Institutional Review Boards (IRB), including writing of abstract, submission of standard forms and drafting of informed consent form.
• Collaborates with investigators during study development to facilitate and confirm that appropriate regulatory safeguards have been included.
• Conducts detailed reviews of assigned protocols and informed consent forms prior to IRB review.
• Ensures timely submission of protocol documents for review by appropriate agency.
• Communicates with sponsors of any research project (industry, federal, collaborative, investigator-initiated) to address concerns and assure compliance.
• Establishes and oversees tracking system to continually monitor progress of protocol review and status of approval.
• Reviews and authorizes protocol revisions and amendments.
• Amends consent forms as needed and follows established guidelines from OSU and NIH (National Institutes of Health) to determine if amendment requires IRB review.
• Distributes amendments and IRB approved informed consent forms to relevant university protocol holders.
• Continually monitors federal and sponsor rules, regulations and processes to identify and interpret new, updated or changed requirements.
• Provides regulatory updates to investigators and research staff of new or changed regulations.
• Participates in audits and site visits.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level