The Human Subjects Research Specialist will support the Human Research Protections Program at Cooper in the regulatory compliance of subjects’ research.
Regulatory Compliance Functions:
Conducts 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.
Develops and revises audit plans, audit tools and standard operating procedures; organizes and delivers individual and group education as necessary; and other activities as assigned.
Instrumental role in the preparation for external inspections, audits and sponsor visits (including but not limited to industry sponsors and NCI). Assures that all site documents, including SOPs and study regulatory files, are maintained in audit-ready condition and attends audits as needed.
Supports 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).
With input and guidance from the Director of the HRPP, establishes and maintains the quality management and possibly needed improvement programs for the Cooper Research Department. Monitors and reports on the programs implemented to senior leadership.
Develops policies, procedures and training materials to ensure that clinical research is conducted in accordance with Institutional requirements, state law, and federal regulations.
Monitors, tracks and reports on the implementation and follow-through of established corrective and preventive action plans (CAPAs) through the system.
Reviews the IRB policies and SOPs for consistency and accuracy.
Institutional Review Board Functions:
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.
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.
Work with the Director of HRPP, Cooper Research leadership, and Cooper Legal to review, negotiate terms and facilitate the execution of IRB reliance agreements.
Act as the liaison between Cooper investigators and others (e.g. external sIRBs, sponsors) to coordinate and implement reliance agreements.
Organize, track and maintain records of all reliance agreements and the covered research activities. Provide summary reports and metrics to the Director of the HRPP and Cooper leadership upon request.
Coordinate and oversee institutional responsibilities outlined in the agreements and/or dictated by federal, state or local laws and policies. This may include, but is not limited to, verifying training of the research team, reviewing consent forms for local context, reviewing financial disclosures for conflicts of interest, ensuring local ancillary reviews are completed, reviewing reports of unanticipated problems or suspected non-compliance.
Perform administrative review of and processing of IRB submissions for research where the Cooper IRB is serving as the single IRB for external sites.
With the Director of the HRPP, develop policies, procedures, and tools to facilitate and streamline the reliance agreement review process, local submissions, and the performance of institutional responsibilities and local review.
Develop sIRB guidance documents, educational tools and templates for the Cooper research community. Conduct training of investigators and research staff on the use of sIRBs.
Assists with regulatory review of submitted human research, as needed.
Conducting training of investigators, study staff, Institutional leadership, IRB members and staff, as needed.
Other special projects, as requested.
Scheduled Days / Hours: Varied day hours
A Bachelor’s degree in an appropriate field or an equivalent combination of education and experience.
Minimum of 5 year of experience in IRB administration, clinical research, clinical trials auditing or regulatory compliance with human subjects
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.
Required License/Certifications/ Registration:
Certification as an IRB Professional (CIP) after two years of working in the position.