We are looking to hire a motivated MANAGER IRB to join our growing team at Cooper University Health Care in Camden NJ US
Growing your career as a Full Time MANAGER IRB is an incredible opportunity to develop exceptional skills.
If you are strong in planning, critical thinking and have the right personality for the job, then apply for the position of MANAGER IRB at Cooper University Health Care today!
About us 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 its employees by providing competitive rates and compensation, a comprehensive employee benefits programs, attractive working conditions, and the chance to build and explore a career opportunity by offering professional development.
Discover why Cooper University Health Care is the employer of choice in South Jersey.
Short Description Responsible for the efficient management of all IRB functions to assure protection of human subjects. The Manager represents the IRB both within and outside the Cooper Health System. The Manager serves as the Human Protections Administrator (HPA) on the Cooper federal wide assurance (FWA) with the HHS Office for Human Research Protections (OHRP). The HPA is responsible for assuring compliance of the institution with FDA and HHS regulations and is responsible for updating the FWA and IRB registration with FDA and HHS and for implementing institutional agreements. The IRB Manager is the primary contact person and facilitator when FDA audits the IRB. Ensures prompt reporting of noncompliance or unanticipated problems to institutional and federal authorities. Trains and supervises the IRB coordinators. Responsible for performance evaluations and employment decisions. Responsible for obtaining required documentation for new IRB members, orientation and education of new IRB members, continuing education of IRB members, and monitoring performance of IRB members (tracking attendance, education, and reviews). Works with IRB Chair and Department of Compliance on selecting studies for IRB audits. Responsible for IRB follow-up on reports of investigator and research staff noncompliance Manages IRB processes, tasks, and schedules. Responsible for quality assurance and for tracking IRB performance and collecting data for reports on IRB performance. Provides assistance to researchers and IRB members in the interpretation of federal regulations and institutional policies. Responsible for ensuring that investigators and research staff comply with federal regulations and institutional policies. Determines if activities need IRB review. Ensures that all IRB activities and documents are in compliance with federal regulations and IRB policies. Conducts quality control checks. Assures that research protocol progress reports are received in a timely manner and processed appropriately by IRB staff and reviewers. Support the IRB staff with their responsibilities Including consultation with investigators and study coordinators in the preparation of IRB submissions; attend IRB meetings; review, triage, process, and track new protocol submissions, amendments, adverse event reports, and progress reports; prepare agendas and minutes of IRB meetings and correspondence with investigators. Administers the online IRB system Axiom Mentor and is responsible for working with the vendor and the Medical Affairs software applications specialist to maintain the integrity and functioning of the system. Revises imedris forms as needed. Interprets both federal and Cooper broad-based Policies. Reviews. revises, and writes Cooper IRB policies as needed. Will implement the use of two external IRBs – the National Cancer Institute Central IRB (NCI CIRB) for some oncology studies and Western IRB for sponsored studies. Works with the Rowan IRB Chair to decide which IRB will review projects conducted by investigators who are affiliated with a combination of the Cooper Health System, Rowan University, and Cooper Medical School of Rowan University. Experience Required 5 years' experience in IRB administration. Supervisory experience and knowledge of federal compliance and regulations required. Education Requirements B.A., B.S. RN or equivalent experience Benefits of working as a MANAGER IRB in Camden NJ US:
? Learning opportunities
? Company offers career progression opportunities
? Attractive package
