IRB Coordinator II

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 functions as the lead contact for one or more IRB Committees and as a subject matter expert in human subject research. The Coordinator intakes and reviews new and continuing human subject research requests for advancement to the IRB Committee or for independent review, applying regulatory guidelines and ethical principles to ensure compliant, complete, and high-quality submissions. The Coordinator provides the essential roles of liaising extensively with project teams, facilitating successful IRB Committee meetings, being a knowledgeable resource for investigators and staff, and exercising judgement reflective of advanced knowledge and training.

Primary Functions

• Within one or more assigned Institutional Review Board (IRB) Committees, review new research project submissions and ongoing documentation, including amendments, reportable events, and continuing progress reports.
• Consult with faculty investigators and coordinators to provide suggestions for improvements and modifications to submissions.
• Provide professional service to the IRB Chair, IRB Committee, and investigators by applying established principles, theories, and concepts to all incoming submissions.
• Exercise discretion and independent judgment to resolve moderately complex issues involving more advanced research into ethical questions.
• Review submitted documents for accuracy and completeness to ensure compliance with institutional, federal, and other regulations.
• Develop the IRB Committee meeting agendas and supplemental materials for distribution, including articles, publications, or statistical reports for review by Committee members.
• Attend IRB meetings to compose summaries of the Committee's deliberations for dissemination to faculty investigators, which highlight Committee concerns, decisions, and the need for follow-up activity.
• Apply discretion and evaluation regarding human subject research projects.
• Provide ongoing mentoring and training to less senior and / or new IRB Coordinators.
• Draft and / or present the monthly Continuing Educational module to the IRB Committee as outlined in the Continuing Education guidance document.
• Independently process submissions for IRB Committees as assigned and according to IRB SOPs and Federal regulations.
• Potentially serve as an IRB Committee member with the ability to approve certain types of submissions.
• Assist HRPP Leadership in identifying areas for enhancement to increase efficiency and compliance, as well as recommending proposed solutions.
• Provide back-up support for other IRB Coordinators as needed.
• Independently manage special projects as assigned.
• Represent the HRPP Office at various educational sessions for the research community

Knowledge - Skills - Abilities

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

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 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 an inclusive 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.