Job Information
MCW: SARGEANT HEALTH CENTER IRB Manager Quality Assurance in MILWAUKEE, Wisconsin
JOB REQUIREMENTS: Position Description: Purpose The Office of Research helps to facilitate life-saving biomedical research at the Medical College of Wisconsin. Nine distinct units provide specialized support to meet the administrative needs of our investigators and research staff, and together we coordinate, regulate, and monitor research projects. Our Human Research Protection Program (HRPP) oversees the safe, ethical, compliant conduct of human subject research via our Institutional Review Boards (IRBs), and with a rigorous ongoing quality assurance program. The Manager, Quality Assurance & Improvement (QA/QI), plays a vital role in assessing IRB approved research projects to ensure compliance with institutional, federal, and other regulations. Leveraging knowledge of human subject research protection, regulations, and post-approval oversight, the Manager works closely with the QA/QI specialists and project teams to review processes, audit records and documentation, and address concerns, all to prioritize the health and wellness of our research subjects and promote research compliance. In addition, the Manager partners with the HRPP Director to lead the For-Cause Audit process in the event the Director or an MCW IRB Committee makes such a request. Primary Functions Train, supervise, manage and evaluate all QI Specialists to carry out duties of the MCW HRPP Quality Assurance/Quality Improvement program. Maintain quality and consistency of QI Specialists work across the QA/QI Program and activities. Oversee the MCW HRPP QA/QI program in the conduct of post-approval monitoring activities including but not limited to: Project start-up monitoring and guidance for research teams conducting research activities at MCW and/or other affiliated locations such as Froedtert Hospital, Versiti, or Children\'s Wisconsin Routine Review of human subject research projects on a regular basis where MCW is serving as the IRB of Record Routine Review of human subject research projects on a regular basis where IRB review has been deferred to another IRB. Observation of research activities as requested by one or more MCW IRB Committees and or the MCW HRPP Director. For-Cause Audits of IRB approved human subject research in response to requests and inquires. Evaluate the implementation of Corrective Action Plan Activities proposed by Investigators in response to events which require prompt reporting to the IRB. Develop policies, procedures and guidance in support of the MCW HRPP QA/QI program and human subject research compliance. Serve in the role of Research Subject Advocate for the MCW HRPP program to respond to research... For full info follow application link. EEO/AA Minorities/Females/Vets/Disability The Medical College of Wisconsin is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, veteran status, disability or sexual orientation. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/CDD80CFB83254AF0 Qualified females, minorities, and special disabled veterans and other veterans are encouraged to apply.