Research Regulatory Coordinator

Froedtert & The Medical College of Wisconsin - Milwaukee, WI

Full-time - Mid Level

Milwaukee, WI

Ambulatory Health Care Services

About the position

The Research Regulatory Coordinator at the Medical College of Wisconsin (MCW) plays a crucial role in the Cancer Center by ensuring compliance with regulatory requirements for human subject research. This position involves preparing and submitting regulatory documents, acting as a liaison among various stakeholders, and facilitating the achievement of the Cancer Center's goals through effective communication and collaboration.

Responsibilities

• Prepare required documents in the MCW/Froedtert electronic IRB system for initial approval, amendments, and continuing progress reports.
• Review documents for accuracy and completeness, identify problems, and perform quality control prior to IRB submission.
• Maintain working knowledge of e-Bridge, electronic IRB, and Grants and Contracts functions.
• Collaborate with principal investigators, sponsors, and study team members while maintaining open communication.
• Recruit, screen, enroll, and obtain consent from program participants.
• Conduct or coordinate training for program participants.
• Coordinate research protocols, including arranging necessary appointments and procedures.
• Collect, analyze, and disseminate program data.
• Report program data and progress to stakeholders.
• Coordinate notifications regarding annual regulatory education requirements.
• Act as a liaison with community organizations for program outreach activities.

Requirements

• Experience in preparing IRB applications and regulatory documents for human subject research.
• Knowledge of e-Bridge, electronic IRB, and Grants and Contracts functions.
• Familiarity with OnCore (Clinical Trials Management software) and the Florence E'Binder System.
• Strong communication and collaboration skills to work with diverse stakeholders.
• Ability to recruit and enroll program participants.

Nice-to-haves

• Experience in a clinical research setting.
• Familiarity with compliance regulations and standard operating procedures.

Benefits

• Health insurance coverage
• Paid holidays
• Professional development opportunities