IRB Manager, 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) 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 Manager, Quality Assurance & Improvement (QA/QI), plays a vital role in assessing IRB approved research projects to ensure compliance with institutional, federal, and other regulations. Leveraging knowledge of human subject research protection, regulations, and post-approval oversight, the Manager works closely with the QA/QI specialists and project teams to review processes, audit records and documentation, and address concerns, all to prioritize the health and wellness of our research subjects and promote research compliance. In addition, the Manager partners with the HRPP Director to lead the For-Cause Audit process in the event the Director or an MCW IRB Committee makes such a request.

Primary Functions

• Train, supervise, manage and evaluate all QI Specialists to carry out duties of the MCW HRPP Quality Assurance/Quality Improvement program.
• Maintain quality and consistency of QI Specialists work across the QA/QI Program and activities.
• Oversee the MCW HRPP QA/QI 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 and or the MCW HRPP Director.
  • 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.
  • Develop policies, procedures and guidance in support of the MCW HRPP QA/QI program and human subject research compliance.
• Serve in the role of Research Subject Advocate for the MCW HRPP program to respond to research participant questions, or complaints.
• Report on the activities of the MCW HRPP QA/QI program including research subject advocate contacts.
• Serve as the MCW HRPP liaison and primary contact for external audits of MCW IRB approved research projects.
• Serve as part of MCW HRPP Research Education team by participating in activities such as:
  • Participate in monthly meetings.
  • Support various research education presentations such as CITI modules, Grand Rounds, and other similar forums.
• Deliver specific human subject research training and education as requested by the MCW IRB Committee or HRPP Director.
• Provide consultation to Principal Investigators and research team members regarding the implementation of quality assurance practices and promote compliance among project teams.
• Respond to compliance-related inquires.
• Coordinate with the HRPP IRB staff to promote compliance in the conduct, documentation and reporting of human subject research.
• Other duties critical to support the MCW HRPP 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:



8:00 a.m. - 5:00 p.m.

Position Requirements:

Specifications

Appropriate experience may be substituted for euducation on equivalent basis

Minimum Required Education: Bachelor's degree

Minimum Required Experience: 5 years

Preferred Education: RN, BSN, allied health professional, or other similar credential

Preferred Experience: Experience in scientific, medical or educational research environment strongly preferred. Experience with clinical research, patient care, or quality assurance in a healthcare setting preferred. Experience managing people preferred.

Field:

Certification: Certified IRB Professional (CIP) preferred but not required

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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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