University of Michigan Health-West (Formally Metro Health) is looking for Institutional Review Board (IRB) Specialist - Clinical Research * Days - 24 hours/week
Under the supervision of Director of Clinical Research, the IRB Specialist supports the Human Research Protection Program at University of Michigan Health-West (UMH-West), including management of the daily functions of the Office of the Institutional Review Board (IRB).
Knowledge, Skills and Abilities:
- BA/BS degree, preferably in a research, scientific or related field.
- Minimum of 3 years direct experience with HRPPs, IRBs, and/or research compliance.
- Experience in project management or process implementations in a healthcare setting.
- Experience with IRB Manager or other IRB data bases, preferred
- 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) preferred, if not, must be obtained within 2 years of employment
- Able 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 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 that reflects the decision of the IRB.
- Maintains accurate electronic IRB files via IRB Manager.
- Review scientific research protocol documents
- Communicates concerns with IRB Chair/Vice-Chair/Members, Institutional Official and research study staff, as applicable, with the goal of resolving issues.
- Coordinates the initial and continuing review of research protocols, all amendments, modifications and administrative actions.
- Conducts internal audits of investigator-initiated studies and assist the research team with duties for active clinical trials.
- Maintain Federal Wide Assurance (FWA) with OHRP (Office of Human Research Protection).
- Investigate participant complaints,
- Maintain a collaborative relationship with researchers with the shared goal of conducting ethical human research at UMH-West.
- Serve as a resource to researchers, responding to questions on preparing IRB submissions and compliance with policies and procedures.
- Provide training to IRB members and researchers in human subjects protections.
- Meets with investigators to advise them on federal regulations and IRB submission requirements and assists them as needed in the preparation of submission forms.
- 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 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 the IRB functions and duties.
- Liaison with applicable institutional departments to develop strategies that allow for the institution to discharge its duty to protect human subjects.
- Assure yearly Conflict of Interest disclosure forms are completed by the appropriate clinical study research team.
