- 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 amp; 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.
Regulatory Compliance Officer
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 im...
Regulatory Compliance Officer
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 im...
Regulatory Compliance Officer
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 im...
Regulatory Compliance Officer
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 im...
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