IRB Coordinator II, Reliance

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 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 impacting the work of others. Ability to work within a deadline-driven environment.

Preferred Schedule:



M-F 8-5 pm (some flexibility)

Position Requirements:

Specifications

Appropriate experience may be substituted on equivalent basis

Minimum Required Education: Bachelor's degree

Minimum Required Experience: 2 years

Preferred Education:

Preferred Experience: Experience in research in a medical research or educational environment preferred. Prior work with clinical research or patient care preferred.

Field:

Certification: CITI within 90 days of hire

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MCW as an Equal Opportunity Employer and Commitment to Non-Discrimination


The Medical College of Wisconsin (MCW) is an Equal Opportunity Employer. We are committed to fostering a diverse community of outstanding faculty, staff, and students, as well as ensuring equal educational opportunity, employment, and access to services, programs, and activities, without regard to an individual's race, color, national origin, religion, age, disability, sex, gender identity/expression, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status. Employees, students, applicants or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic.

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