IRB Coordinator III - Reliance - Research Office
Summary
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 III, 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 III, 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 Responsibilities Serve as the MCW point of contact for reliance and single IRB (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 Reliance Manager 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. . Review and process commercial notifications and notifications of issues identified with other IRBs (e.g. serious or continuing noncompliance, UPRISOs), advising study teams when additional action is required. Process staff changes and site preferences for NCI CIRB. Process closure reports for projects where MCW as a site is closing or the project is closing in its entirety. Notify external sites when a project that has MCW serving as IRB for an external site has closed. Working with the Reliance Manager, prepare and submit annual NCI CIRB and NMDP IRB annual signatory worksheets. Review and process reliance requests within the parameters of existing agreements and MCW IRB oversight jurisdiction. Execute reliance agreements according to MCW SOP, FDA and OHRP Regulations. Develop and represent the HRPP Office as a presenter and subject matter expert at reliance and sIRB related educational sessions. Attend national & local consortia meetings in support of MCW participation within these organizations. Support intake of new reliance requests for projects relying on an external IRB, and for projects where MCW is as the sIRB. Review reliance requests for accuracy and completeness to ensure compliance with IRB SOPs, OHRP and Federal Regulations. Request modifications Ensure all required elements are present and generate a synopsis. Prepare reliance decision letters as needed Utilize and enhance tools to track and report metrics on reliance and sIRB requests. Resolve moderately complex issues involving more advanced research. Apply thoughtful logic and sound reasoning when evaluating reliance and sIRB requests. Other duties as assigned to support HRPP initiatives. Knowledge – Skills – Abilities A demonstrated working knowledge of the federal regulations governing human subjects research is required. Exceptional analytical ability is necessary in order to apply knowledge of federal regulations and institutional policy to research submissions. Excellent oral and written communication skills are essential, with a demonstrated ability to organize, write about and discuss regulatory and complex issues clearly. Computer proficiency is required, including MS Word, Excel, Teams, internet browsers, and email. The IRB review process is conducted via an electronic web-based system, which will require individuals to be comfortable reading on a screen and to easily switch back and forth between screens to obtain and synthesize information. Ability to work independently and as part of an inter-dependent team. Ability to effectively plan and organize projects and reviews. Ability to work within a deadline-driven environment.
Qualifications
Appropriate experience may be substituted for education on an equivalent basis. Minimum Required Education: Bachelor’s Degree Minimum Required Experience: 5 years Physical Requirements Work requires infrequent physical effort such as walking or retrieving materials.
Work Environment
May experience slightly disagreeable features such as temperature changes or noise from time to time. Work performed in an environmentally controlled environment. Sensory Acuity Ability to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects. #LI-AV1 Why MCW? Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental. Along with Flexible Spending options Apply tot his job Apply To this Job