IRB Coordinator II, Quality Assurance & Improvement

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 projects. Our Human Research Protection Program (HRPP) Office oversees the safe, ethical, compliant conduct of human subject research via our Institutional Review Boards (IRBs), and with a rigorous ongoing Quality Assurance Program.

The IRB Coordinator II, Quality Assurance & Improvement, plays a vital role in assessing IRB approved projects to ensure compliance with institutional, federal, and other regulations. This position requires effective and applicable knowledge of regulatory and institutional requirements as well as critical thinking as the Coordinator works closely with project teams to review processes, audit records and documentation. The Coordinator functions as a subject matter expert in human subject research compliance when providing feedback to the research team and addressing the research team's concerns, all to prioritize the health and wellness of our research subjects and promote research compliance.

Primary Functions

• Independently perform activities of the MCW HRPP QA Program in the conduct of post-approval monitoring activities including but not limited to:
  • Project start-up monitoring and guidance for research teams conducting research activities at MCW and/or other affiliated locations such as Froedtert Hospital, Versiti, or Children's Wisconsin
  • Routine Review of human subject research projects on a regular basis where MCW is serving as the IRB of Record
  • Routine Review of human subject research projects on a regular basis where IRB review has been deferred to another IRB.
  • Observation of research activities as requested by one or more MCW IRB Committees, or the MCW HRPP Director or the Principal Investigator of the project.
  • For-Cause Audits of IRB approved human subject research in response to requests and inquires
  • Evaluate the implementation of Corrective Action Plan Activities proposed by Investigators in response to events which require prompt reporting to the IRB.
  • Provide feedback and guidance to research team members post-review regarding the conduct, documentation and reporting of human subject research activity.
  • Record and report findings to designated individuals and maintain records of reviews and findings.
• Exercise discretion and independent judgement to resolve moderately complex issues involving more advanced research into ethical and compliance questions
• Provide ongoing mentoring and education to research team members regarding the implementation of quality assurance practices and promote research compliance among project teams.
• Respond to compliance-related inquiries as requested by QA Manager.
• Collaborate with the HRPP IRB staff to promote compliance in the conduct, documentation and reporting of human subject research.
• Represent HRPP Office at various educational sessions for the research community
• Assist HRPP leadership in identifying areas for enhancement to increase efficiency and compliance as well as recommending proposed solutions.
• Independently manage special projects as assigned
• Provide back-up support to other specialists as needed
• Other duties critical to support the MCW HRPP QA Program as assigned.

Knowledge - Skills - Abilities

Excellent oral and written communication skills are essential. Proficiency in the use of Microsoft Office suite, specifically Word and Excel database technology are required.

Must be able to learn and understand IRB Standard Operating Procedures and federal regulations governing human subject research, including those of the Office of Human Research Protections and the FDA. Exceptional analytical ability is necessary to apply knowledge of federal regulations and institutional policy to research submissions.

Must be able to work independently as well as part of an inter-dependent team. Ability to liaise with research teams across the institution and foster collaborative working relationships is desired. Ability to effectively plan and organize projects impacting the work of others, and to work in a deadline-driven environment is critical.

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: None

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

Certification: CITI within 90 days of hire, progress toward Certified IRB Professional (CIP) preferred

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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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