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 (HRPP) Office oversees safe, ethical, compliant conduct of human subject research via our Institutional Review Boards (IRBs).
The HRPP Operations Supervisor functions as a critical leader for IRB Operations and provides necessary support to the HRPP Operations Manager Senior and HRPP Associate Provost for Research. The Supervisor supports leadership in oversight of day-to-day operations, financial management, personnel, and resources. The Supervisor helps centralize administrative and business functions in the HRPP office and manages the IRB Administrative Support Specialist. The Supervisor also leads and assists with special projects and serves as a key point of contact for the HRPP.
- Support the workload of the HRPP Operations Manager Senior including participation in meetings, representation on workgroups, leading tasks and special projects, and other delegated duties.
- Configure and maintain data for IRB metrics including overall submissions, turnaround times, data trends and staffing levels.
- Analyze data trends for strengths, weaknesses, opportunities, and gaps
- Assess process flows against data to identify opportunities for efficiency
- Report on IRB metrics for leadership
- Lead special projects and one-time operational initiatives as either self-directed or at the discretion of the HRRP Operations Manager Senior.
- Support the coordination, planning, and implementation of the operational activities of the unit ensuring efficiency and compliance with Department, College, Federal and State policies and procedures.
- Support select tasks for the annual budget process.
- Train, supervise, and manage the IRB Administrative Support Specialist. Delegate work to the Specialist as needed and partner with the Specialist on office-wide tasks. Execute supervisory functions including performance reviews and corrective actions, and work with departmental human resources support to resolve issues and concerns.
- Work with the Research Education group to deploy special trainings or learning opportunities as needed.
- Serve as a source of regulatory knowledge and operational expertise for institutional research leaders.
- Ensure compliance and provide guidance and direction on FDA and OHRP regulations and MCW Standard Operating Procedures (SOPs) in relationship to MCW, Froedtert, Versiti and Children’s Wisconsin (CW) human subject research protocol submissions.
- Serve as a rostered Committee member on one or more IRB Committees.
- Work with the HRPP Operations Manager Senior and the eBridge IT team to discuss eBridge problems and test eBridge fixes.
- Attend monthly IRB Chairs meeting, IRB Coordinator III meetings and HRPP staff meetings as required.
- Other duties as assigned.
8:00 a.m. - 5:00 p.m.
Knowledge – Skills – Abilities
Must be able to work independently as a self-starter and also be able to effectively lead an inter-dependent team. Ability to liaise with partner institution offices and foster collaborative working relationships is necessary.
Must have strong customer service skills that includes courteous and helpful behavior; accomplishing tasks through teamwork and initiative; ensuring timely and thorough responses to complaints and critiques; and anticipating the needs of all those with whom you work.
Proven ability to maintain balance between positive relationships with external organizations and internal personnel while adhering to the requirements of multiple institutions. Ability to maintain confidences, perform effectively in a stressful, deadline-driven environment, and effectively plan and organize projects impacting the work of others
Must be able to learn and understand IRB Standard Operating Procedures and federal regulations governing human subjects 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 in practical applications.
Excellent oral and written communication skills are essential. Proficiency in the use of Microsoft Office suite, specifically Word and Excel database technology, are required.
Building: MACC Fund Research Center (MFRC); some flexibility for virtual and/or hybrid work is included in this role.
Department: Office of Research
Division: Institutional Review Board (IRB)
Reports to (Title): HRPP Operations Manager Senior
Direct Reports (Titles): IRB Coordinator I
Collaborates with (Titles): Faculty members serving as Principal Investigators, IRB Committee members and research staff. External IRB offices, Affiliate Organizations, Office of Research Compliance, Department Administrators
Appropriate experience may be substituted on equivalent basis
Minimum Required Education: Bachelor’s degree
Minimum Required Experience: 5 years
Preferred Education: Health Sciences, business, or healthcare administration
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.
Commitment to Diversity
MCW is one of the largest healthcare employers in Wisconsin. We are committed to creating an inclusive and welcoming workplace that includes individuals with diverse backgrounds and experiences. We believe that embracing human differences is critical to realize our vision of a healthier world, and we recognize that a healthy and thriving community starts from within. We strive to integrate our human and social differences into MCW’s functioning, strategies and culture to create a diverse and equitable workplace. If you believe embracing individuality and working together makes us stronger, then MCW is the place for you. People of color, women, LGBTQIA+, veterans and persons with disabilities are encouraged to apply.
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.