Research Regulatory Coordinator

The Medical College Of Wisconsin • Milwaukee, WI

398d

About The Position

The Research Regulatory Coordinator at the Medical College of Wisconsin plays a crucial role in the Cancer Center by ensuring compliance with regulatory requirements for human subject research. This position involves preparing and submitting IRB applications, amendments, and progress reports, while acting as a liaison between various stakeholders including sponsors, principal investigators, and study team members. The coordinator will also be responsible for maintaining communication, conducting training, and coordinating research protocols to facilitate the achievement of the Cancer Center's goals.

Requirements

• Associate degree in a relevant field.
• 1 year of experience in regulatory compliance or clinical research.
• Excellent oral and written communication skills.
• Strong critical thinking and problem-solving abilities.
• Attention to detail.

Nice To Haves

• Bachelor's degree in a relevant field.
• Experience in regulatory compliance in the healthcare field or clinical research.
• Additional training in regulatory compliance.

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, identifying problems and performing quality control prior to IRB submission.
• Collaborate with principal investigators, sponsors, and study team members, maintaining open communication.
• Recruit, screen, enroll, and obtain consent from program participants.
• Conduct or coordinate training for program participants.
• Coordinate research protocols, arranging necessary appointments and procedures, and maintaining contact with study participants.
• Collect, analyze, and disseminate program data, reporting progress to stakeholders.
• Coordinate notifications regarding annual regulatory education requirements for study team members.
• Act as a liaison with community organizations for program outreach activities.
• Identify and communicate problems or obstacles related to research protocol implementation.
• Assist in the preparation of IRB documents and reports, and in the evaluation and writing of research protocols.
• Collaborate on the development of program materials including educational and marketing materials, websites, forms, and reports.
• Maintain program timelines and track deadlines for program components.

Benefits

• Paid parental leave
• Paid holidays
• Dental insurance
• Tuition reimbursement
• Vision insurance
• 403(b) retirement plan
• Pet insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Educational Services
• Education Level: Associate degree