IRB Coordinator II - Research Office

Summary

Responsible for monitoring and ensuring compliance with moderately complex OHRP and FDA regulations and Institutional Standard Operating Procedures.

• Assigned to one or more IRBs, review protocols, amendments, protocol deviations, serious adverse events, and continuing progress reports.
• Consult with research coordinators and investigators to provide suggestions for improvements and modifications to submissions.
• Provide professional service to the Chair, IRB Committee, and clinical investigators which involve the application of established principles, theories and concepts.
• Resolve moderately complex issues involving more advanced research into ethical questions.
• Consult with the IRB chair to determine the most appropriate course of action for review.
• Conduct meeting preparation, and meeting follow-up for human subject protocols.
• Draft Standard Operating Procedures for newly creating or existing processes.
• Prepare approval letters for signature and other appropriate documents.
• Prepare study related documents for review by Chair and/or committee.
• Review submitted documents for accuracy and completeness as per IRB regulations.
• Other duties as assigned.

• Knowledge of biology, chemistry, mathematics, documentation, and records management.
• Data utilization, complex problem solving, critical thinking, resource management, and writing skills.

Minimum Required

Education:

Bachelor's degree

Minimum

Required Experience:

3 years

Required Certification/Licensure(s): CITI within 90 days of hire

Work requires occasionally lifting moderate weight materials, standing, or walking continuously.

Occasional exposure to dust, noise, temperature changes, or contact with water or other liquids. Work is performed in an environmentally controlled environment.

Ability to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects.

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.