Position Description:

Clinical Research Coordinator III/Regulatory Specialist-IRB

Purpose

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. In the regulatory specialist capacity, will function as the regulatory liaison with sponsors, principal investigators, study team members and the IRB providing support to facilitate the achievement of the research team goals. Coordinate the day-to-day administrative activities of the clinical research trials program. Provide support to the team to facilitate the achievement of the program's goals. Recruit, train, and supervise staff and manage study budgets.

Primary Functions
Clinical Research Coordinator III

• Oversee the recruitment, screening, enrolling and obtaining of 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.
• Oversee the collection, analysis, and dissemination of research data. Report program data and progress to study investigators. Develop, implement and maintain comprehensive databases and files related to the program.
• 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.
• Prepare IRB documents and reports. Evaluate and write of research protocols in collaboration with the study investigator.
• Coordinate and manage program outreach activities including acting as a liason with community organizations.
• Collaborate on the development of program materials including educational materials, marketing materials, websites, forms, and reports.
• Manage program timeline including tracking deadlines for program components.
• Coordinate and manage program outreach activities including acting as a liaison with community organizations. Organize internal and external meetings, site visits, and special events.
• Manage study related budgets and provide reports as required to department administration and funding agencies. Participate in the development of program resources through literature searches, contact with outside programs, and review of funding opportunities
  • Provide main administrative support for the preparation of multiple Internal Review Board (IRB) documents. Assist in drafting and submitting protocols, protocol summaries, amendments, protocol deviations, serious adverse events, continuing progress reports, and consent-to-treat documents. Following IRB guidelines, draft and/or modify documents as required by research program activities.
  • 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.
  • Support faculty with Investigator-Initiated IND/IDE applications; maintain IRB and FDA regulatory files for each IND/IDE and ensure routine monitoring is conducted as required.

Research Regulatory Specialist

• Facilitate study start up activities, as necessary, including: submissions to Scientific Review Committee (SRC), Data Safety Monitoring Board (DSMS), Institutional Biosafety/Radiation Safety Committee, and ClinicalTrials.gov postings.
• Work closely with Research Managers and Research Coordinators to identify and complete all regulatory needs associated with each assigned protocol.
• Identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicate to supervisor and study investigators.
• Assure that the regulatory activities comply with various federal and state laws, and institutional standard operating procedures.
• Collaborate with investigators and Research nurses/study coordinators on the development of program materials including educational materials, marketing materials, websites, forms, and reports.
• Maintain program timeline including tracking deadlines for program components. Utilize MCW's Clinical Trial Management System (CTMS) OnCore to assist with meeting regulatory requirements and tracking activities. Collect, analyze, and disseminate program data. Report program data and progress to program stakeholders.
• Coordinate notifications to all study team members regarding annual regulatory education requirements
• Work with Principle Investigator to develop, implement, and maintain comprehensive databases and files related to the program.

Knowledge - Skills - Abilities

Knowledge of biology, chemistry, mathematics, documentation, and records management. 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.

Data utilization, complex problem solving, critical thinking, resource management, and writing skills.

Preferred Schedule:

Position Requirements:

Specifications

Appropriate experience may be substituted for education on equivalent basis

Minimum Required Education: Bachelor's Degree

Minimum Required Experience: 5 years

Preferred Education:

Preferred Experience:

Field:

Certification: CITI training within 90 days of hire. SoCRA and ACRP certification preferred.

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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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