Our Cooper Team is growing! As the leading academic health care system in South Jersey, affiliated with Cooper Medical School of Rowan University, Cooper University Health Care fosters the growth of research in the areas of medical education, the science of health care delivery and population health, and targeted translational research. Join us today as a Human Subjects Research Specialist by clicking here.
In your role as a Human Subjects Research Specialist, you will support the Human Research Protections Program at Cooper in the regulatory compliance of subjects’ research. Among your regulatory compliance functions, you will conduct internal routine and focused study audits of research activities involving human subjects, including but not limited to patient binders, regulatory binders, standard operating procedures (SOPs), and policies. You will have an instrumental role in the preparation for external inspections, audits and sponsor visits (including but not limited to industry sponsors and NCI), assuring that all site documents, including SOPs and study regulatory files, are maintained in audit-ready condition and attending audits as needed. You will also support Investigators and the Study Team to comply with national regulations and guidelines from the Food and Drug Administration (FDA), Office for Human Protection (OHRP), International Conference on Harmonization-Good Clinical Practice (ICH-GCP).
As part of your Institutional Review Board functions, you will serve as the primary point of contact for Cooper investigators and research staff whenever the Cooper IRB will either rely on the review of an external sIRB or serve as the single IRB for other sites. You will conduct independent, in-depth reviews of requests to rely (either requests for external sites to rely on Cooper IRB, or requests for the Cooper IRB to rely on an sIRB) and determine whether the requests are in accordance with Cooper policies and procedures. You will also work with the Director of HRPP, Cooper Research leadership, and Cooper Legal to review, negotiate terms and facilitate the execution of IRB reliance agreements.
Qualified applicants must have a Bachelor’s degree in an appropriate field or an equivalent combination of education and experience, as well as a minimum of five years of experience in IRB administration, clinical research, clinical trials auditing or regulatory compliance with human subjects. You must also have knowledge of the Common Rule (45 CFR 46), FDA regulations, ICH Good Clinical Practice Guidelines, and other relevant requirements and guidelines related to the ethical study of human research subjects.
Certification as an IRB Professional (CIP) is required after two years of working in the position.
If you’re ready to join our Cooper team, we’re ready to hear from you. Learn more and apply today.
At Cooper University Health Care, our commitment to providing extraordinary health care begins with our team. Our extraordinary professionals are continuously discovering clinical innovations and enhanced access to the most up-to-date facilities, equipment, technologies, and research protocols. We have a commitment to our employees by providing competitive rates and compensation, comprehensive employee benefits programs, attractive working conditions, and the chance to build and explore a career opportunity by offering professional development.
Please feel free to refer a friend to these openings! To see additional opportunities available at Cooper and to apply, please visit jobs.cooperhealth.org.
Cooper University Health Care is an equal employment opportunity employer and does not discriminate on the basis of gender, race, age, religion, disabilities, marital status, protected Veteran status, national origin, or any other category protected by federal or state law.