Research Regulatory Coordinator

Position Description:

We're looking for those individuals-the creative thinkers and innovation seekers-who are content with nothing short of changing the world. Discover the endless opportunities within the Medical College of Wisconsin (MCW) and be inspired by the work we can do together to improve health, and make a positive, daily impact in our communities. In the role of a Research Regulatory Coordinator you will be working in the Cancer Center.

As a member of the Cancer Center CTO Regulatory team responsible for gathering regulatory documents, preparing IRB applications, amendments and continuing review for human subject research ensuring compliance with Federal, State and Institutional Standard Operating Procedures. This CTO Research Regulatory Coordinator will function as a regulatory liaison with sponsors, principal investigators, study team members and the IRB providing support to facilitate the achievement of the Cancer Center CTO's goals.

Primary Functions

• Prepare the required documents in the MCW/Froedtert electronic IRB system for initial approval, amendments, and continuing progress reports. Review for accuracy and completeness, identify problems, and perform quality control based on established checklists prior to IRB submission
• Working knowledge of e-Bridge, electronic IRB and Grants and Contracts functions.
• Working knowledge of OnCore (Clinical Trials Management software) and the Florence E'Binder System
• Work collaboratively with principal investigators, sponsors, study team members as well as representatives in other departments and institutions and 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, working collaboratively with other departments and institutions, and maintaining contact with study participants.
• Collect, analyze, and disseminate program data. Report program data and progress to program stakeholders.
• Coordinate notifications to study team members regarding annual regulatory education requirements
• Coordinate program outreach activities including acting as a liaison with community organizations, providing regulatory support for the Cancer Centers at Froedtert Menomonee Falls, Froedtert West Bend, Drexel Town Square Health Center, Moorland Reserve Medical Center, and others as applicable.
• Identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicate to the study investigators.
• Assure compliance with all relevant IRB and other regulatory agency requirements.
• Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
• Collaborate on the development of program materials including educational materials, marketing materials, websites, forms, and reports.
• Work with Principal Investigator to develop, implement, and maintain comprehensive databases and files related to the program.
• Maintain program timeline including tracking deadlines for program components. Utilize MCW's Clinical Trial Management System (CTMS) to assist with meeting regulatory requirements and tracking activities. Collect, analyze, and disseminate program data. Report program data and progress to program stakeholders.
• Coordinate program outreach activities including acting as a liaison with community organizations.

Knowledge - Skills - Abilities

Excellent oral and written communication skills are essential. Strong critical thinking, problem solving and attentiveness to detail required. Additional training in regulatory compliance strongly preferred.

Preferred Schedule:



Fulltime 8:00-4:30 Monday - Friday

Position Requirements:

Specifications

Appropriate experience may be substituted for educaiton on an equivalent basis

Minimum Required Education: Associate degree

Minimum Required Experience: 1 year

Preferred Education: Bachelor's degree

Preferred Experience: Regulatory compliance in healthcare field, clinical research

Field: Sciences or compliance

Certification: CITI training within 30 days of hire.

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
• 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 full list of positions see: www.mcw.edu/careers

For a brief overview of our benefits see: https://www.mcw.edu/departments/human-resources/benefits

Eastern Wisconsin is a vibrant, diverse metropolitan area. MCW is intent on attracting, developing, and retaining a diverse workforce and faculty body that reflects the community we serve. We value diversity of backgrounds, experience, thought, and perspectives to advance excellence in science and medicine. MCW is a welcoming campus community with a strong culture of collaboration, partnership, and engagement with our surrounding community. For more information, please visit our institutional website at https://www.mcw.edu/departments/office-of-diversity-and-inclusion.

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 a diverse 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.

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