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Job Title:
Regulatory Compliance Officer - Clinical Trials OfficeDepartment:
CCC | Clinical Trials OfficePosition 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
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:
This position is primarily remote. New employees are required to attend in-person training sessions and orientation during onboarding. Following completion of onboarding, employees will be expected to attend occasional in-person activities such as meetings, audits, monitoring visits, site initiation visits, etc.
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.
Research Administration - Research Compliance - Individual Contributor - Specialized - S2
Location:
Optometry Clinic (1041)Position Type:
RegularScheduled Hours:
40Shift:
First ShiftFinal candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.
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