Regulatory Compliance Officer - CCC | Clinical Trials Office

Position Summary

The Regulatory Compliance Officer assures that research protocols of the OSUCCC Clinical Trials Office (CTO) are in compliance with University, state and federal regulations; ensures timely submission of all appropriate paperwork for review by appropriate agency.

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

Bachelors Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required; one 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.

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 tomorrows standard of care today. A Cancer-Free World Begins Here.