Regulatory Compliance Officer

1 month ago

Columbus, Ohio, United States The Ohio State University Full time

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Job Title

Regulatory Compliance Officer

Department

Medicine | Center for Clinical Research Management

Regulatory Compliance Officer who 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's CTMO (Clinical Trials Management Organization); 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.

Minimum Education Required

Bachelor's Level Degree or equivalent combination of education and experience

Required Qualifications

Bachelor's degree in relevant field required or equivalent combination of education and experience; 2 years of experience in a clinical research or administrative capacity working on clinical research projects required; considerable knowledge of clinical research regulations and compliance issues especially related to the use of human and animal subjects required; experience and knowledge of federal & industry research sponsor requirements preferred; experience in a regulatory affairs capacity in a medical research setting desired; experience in protocol development desired.

Requires successful completion of a background check. Selected candidate may be requested to complete a pre-employment physical including a drug screen.

Additional Information Location

Davis Heart and Lung Research Institute (0113)

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 Ohio State University is an equal opportunity employer.

All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability, ethnicity, gender identity or expression, genetic information, HIV/AIDS status, military status, national origin, race, religion, sex, gender, sexual orientation, pregnancy, protected veteran status, or any other basis under the law.

Applicants are encouraged to complete and submit the Equal Employment Identification form.

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