IRB Coordinator II - Research Office

About the role

Responsible for monitoring and ensuring compliance with moderately complex OHRP and FDA regulations and Institutional Standard Operating Procedures. Primary Responsibilities 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 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 - Skills - Abilities Knowledge of biology, chemistry, mathematics, documentation, and records management. Data utilization , complex problem solving, critical thinking, resource management, and writing skills.

Requirements

• Appropriate experience may be substituted for education on an equivalent basis.
• Minimum Required Education: Bachelor's degree
• Minimum Required Experience: 3 years
• Required Certification /Licensure( s) : CITI within 90 days of hire
• Physical Requirements
• Work requires occasionally lifting moderate weight materials, standing, or walking continuously.
• Work Environment
• Occasional exposure to dust, noise, temperature changes, or contact with water or other liquids. Work is performed in an environmentally controlled environment.
• Sensory Acuity
• Ability to detect and translate speech or other communication required . May occasionally require the ability to distinguish colors and perceive relative distances between objects.
• #LI-AV1
• Why MCW?
• Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental. Along with Flexible Spending options
• 403B Retirement Package
• Competitive Vacation and Paid Holidays offered
• Tuition Reimbursement
• Paid Parental Leave
• Employee & Family Assistance Program (EFAP)
• Pet Insurance
• On campus Fitness Facility, offering onsite classes
• Additional discounted rates on items such as: Select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment etc.
• For a brief overview of our benefits see: Benefits Overview
• For a full list of positions see: MCW Careers
• MCW as an Equal Opportunity Employer and Commitment to Non-Discrimination:

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