IRB Coordinator II Reliance

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 studies. Our Human Research Protection Program Office oversees safe, ethical, compliant conduct of human subjects research via our Institutional Review Boards (IRBs). The IRB Coordinator II, Reliance, is responsible for monitoring and ensuring compliance in certain situations where MCW, multiple sites, or external organizations rely on another IRB for study review, approval, and continuing oversight. The IRB Coordinator II, Reliance, routinely applies working knowledge of the Office for Human Research Protections (OHRP) regulations and guidance, Federal regulations, and Institutional Standard Operating Procedures to evaluate and manage reliance requests. Primary Functions Intake new reliance requests for projects relying on an external IRB, and for projects where MCW is serving as single IRB (sIRB). Review reliance requests for accuracy and completeness to ensure compliance with IRB SOPs, OHRP and Federal Regulations. Request modifications in consultation with the IRB Manager for Multi-site Research and study teams. Ensure all required elements are present and generate a synopsis. Prepare reliance decision letters after leadership review and determination. Serve as the MCW point of contact for reliance and sIRB requests. Field phone calls and other inquiries and respond to inquiries for IRB Managers. Triage inquiries for reliance and sIRB requests; manage MCW IRB Reliance email inbox, escalate to IRB Manager for Multi-site Research as needed Independently consult with Investigators and study teams to ensure reliance requests are complete and accurate, provide suggestions for improvements and modifications, and request changes as needed. Review and process external notifications and requests from other IRBs as directed by the IRB Manager for Multi-site Research. Review and process commercial notifications and notifications of issues identified with other IRBs (e.g. serious or continuing noncompliance, UPRISOs) Process staff changes and site preferences for NCI CIRB, assist the IRB Manager for Multi-site Research with annual NCI CIRB updates. Develop and represent the HRPP Office as a presenter and subject matter expert at reliance and sIRB related educational sessions. Utilize and enhance tools to track and report metrics on reliance and sIRB requests. Resolve moderately... 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/7CE536B951FC43E6 Qualified females, minorities, and special disabled veterans and other veterans are encouraged to apply.