Human Research Protection Program Officer - Clinical Research * Days - 40hrs/wk

Metro Health | Wyoming, MI

Posted Date 2/22/2018
Description General Summary: Under the supervision of the Director of Clinical Research, the Human Research Protection Program (HRPP) Officer is responsible to support the Human Research Protection Program at Metro Health Hospital, including management of the daily functions of the Office of the IRB (Institutional Review Board). Requirements: BA/BS degree, preferably in a research, scientific or related field.MA/MS/MBA degree preferred.Minimum of 10 years direct experience with HRPPs, IRBs, and/or research compliance.Experience in project management or process implementations in a healthcare setting.Extensive knowledge of both DHHS (45 CFR 46) and FDA (21 CFR 50 and 56) human subjects regulations and appreciation of regulatory, ethical and compliance principals.Medical/healthcare knowledge with clinical experience.Certified IRB Professional (CIP) or Certified IRB Manager (CIM)Comfortable and experienced with public speakingAble to travel, minimally, to attend national professional conferences.Excellent written and oral communication.Self-motivated.  Able to set priorities and work independently yet within a collaborative environment.Able to coordinator multiple activities concurrently in a fast-paced, deadline-oriented environment with multiple interruptions.Advance computer skills including Microsoft Office, with emphasis on Word, PowerPoint, Excel and GroupWise/Outlook.  Essential Functions and Responsibilities: Responsible for managing the operations of the Office of the IRB, and for improving IRB practices, compliance, and operational efficiencies for the review of all active human research projects. Create and prepare IRB meeting agendas, schedules and attends meetings and records the official minutes.Review scientific research protocol documents and is able to identify substantive regulatory issues.  Communicates concerns with IRB Chair/Vice-Chair/Members, Institutional Official and research study staff, as applicable, with the goal of resolving pertinent issues.  Conduct human subjects research determinations, exempt determinations and expedited protocol reviews.  Coordinates the initial and continuing review of research protocols, all amendments, modifications and administrative actions.  Reviews and edits documents to be used to obtain informed consent and authorizations to use and disclose Protected Health Information for research.Maintain Federalwide Assurance (FWA) with OHRP (Office of Human Research Protection).Investigate participant complaints, review adverse event and IND safety reports, and monitor investigator study files with emphasis on investigator initiated protocols, to verify compliance with established IRB policies, good clinical practice guidelines and applicable Federal and other regulations for the protection of human subjects in research.Maintain a collaborative relationship with researchers with the shared goal of conducting ethical human research at Metro Health Hospital.  Serve as a resource to researchers, responding to questions on preparing IRB submissions and compliance with policies and procedures.  Assist researchers in developing appropriate procedures for their studies.Provide training to IRB members and researchers in human subjects protections.  Oversee formal HRPP training requirements, to include CITI (Collaborative Institutional Training Initiative), PRIM&R (Public Responsibility in Medicine and Research), SCS (MSU Statewide System Campus) modules.  Maintain HRPP training completion records.In conjunction with the Director, develop, recommend, review and implement written institutional HRPP policies and procedures that are compliant with applicable regulations and policies.  Participate in FDA and other regulatory site inspections.Ensure continuing institutional compliance in discharging its responsibilities for protecting the rights and welfare of human subjects of research as required by applicable federal regulations.  Respond promptly to detected issues and lead internal monitoring relating to Office of the IRB functions and duties.  Liaison with applicable institutional departments including Clinical Research Department, Corporate Compliance, Nursing, Medical Education, Administration, and Fiscal Services to develop strategies that allow for the institution to discharge its duty to protect human subjects.Active committee member participation, as requested by the Director, which may include COI (Conflict of Interest) in Research Committee, Institutional Review Board, Metro Health Ethics Committee, Graduate Medical Education Committee. Membership in national and/or regional human subjects organization.
Medical / Health Care
Job Type
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Address5900 Byron Center Ave SW
Wyoming, MI 49519