(Archived) Research Regulatory Specialist - Pediatric Hematology/Oncology/Bone Marrow Transplant

The Medical College of Wisconsin brings a synergy between the best medical education, research and patient care. Tomorrow’s discoveries happen right here alongside the very people who bring those lessons to our students. Every bit of knowledge, and every advancement, provides our students with an unprecedented, collaborative learning environment, and helps improve the vitality and care of our communities.

In the role of Research Regulatory Specialist working in Milwaukee, Wisconsin. The Research Regulatory Specialist is a member of the MACC Fund Center Clinical Trials Office (CTO) Research Regulatory team are 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 Specialist will function as a regulatory liaison with sponsors, principal investigators, study team members and the IRB providing support to facilitate the achievement of the CTO’s goals.

Responsibilities:

• Prepare the required documents in the 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
• Works collaboratively with principal investigators, sponsors, study team members as well as representatives in other departments and institutions and maintaining open communication.
• Conduct or coordinate training for program participants.
• Coordinate notifications to study team members regarding annual regulatory education requirements
• 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 Principle 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.
• Perform other duties as assigned.
• Certification: CITI training within 30 days of hire.

Preferred Schedule:
Monday-Friday; Full-time role with expectation for coverage during core business hours and flexibility required to meet changing business needs

Position Requirements:

Minimum Qualifications:

Appropriate experience may be substituted for education on an equivalent basis

*Minimum Required Education: Associate's Degree

*Minimum Required Experience: 1 year

Preferred Education: Bachelor’s degree

Preferred Experience: Regulatory compliance in healthcare field, clinical research

Why MCW?

Outstanding Healthcare Coverage, including but not limited to Health, Vison, and Dental. Along with Flexible Spending options

• 403B Retirement Package
• Competitive Vacation and Paid Holidays offered
• Tuition Reimbursement
• On campus Fitness Facility, offering onsite classes.
• Additional discounted rates on things as: Select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment etc.

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

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

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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