Regulatory Compliance Officer - Clinical Trials Office

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Responsibilities

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 all CTO research projects sponsors (academic, federal, industry) to ensure compliance Interfaces with various internal and external entities to coordinate and effectively compile all appropriate data relevant to the conduct of a CTO trial Develops IRB submission packets for protocols, including writing of abstract, submission of standard forms and drafting of informed consent forms Provides and maintains tracking system to assess progress of a protocol's review; maintains regulatory essential files on submitted and approved studies Reviews all protocol revisions and amendments; amends consent forms if needed and follows established guidelines to determine if amendments requires IRB review Distributes all amendments and IRB approved informed consent forms to relevant university protocol holders Acts as main point of contact for the dissemination of all approved study material and works collaboratively with various internal and external departments to ensure relevant updates are communicated effectively and timely Attends meetings; serves as principal contact from CTO to regulatory agencies including FDA and IRBs Continually monitors federal and sponsor rules, regulations and processes to identify and interpret new, updated or changed requirements Provides regulatory updates and guidance to investigators and research staff of new or changed regulations; participates in audits and site visits Job Requirements 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. Additional Information: Research Administration / Research Compliance - Individual Contributor - Specialized - S2 Experienced As one of only 50 designated comprehensive cancer centers in the nation, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute is dedicated to the creation of knowledge in laboratory, clinical and population-based cancer research. We apply those discoveries to develop more effective approaches to cancer prevention, diagnosis, and therapies – providing tomorrow’s standard of care today. A Cancer-Free World Begins Here. Location: Remote Location Position Type: Regular Scheduled Hours: 40 Shift: First Shift Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process. Thank you for your interest in positions at The Ohio State University and Wexner Medical Center. Once you have applied, the most updated information on the status of your application can be found by visiting the Candidate Home section of this site. Please view your submitted applications by logging in and reviewing your status. For answers to additional questions please review the frequently asked questions. The university is an equal opportunity employer, including veterans and disability. Apply To This Job