Research Regulatory Specialist

Position Description:

Purpose

The Research Regulatory Specialist is responsible for gathering regulatory documents and preparing IRB applications, amendments, and continuing review submissions for human subject research, ensuring compliance with Federal, State, and Institutional Standard Operating Procedures. This role serves as the regulatory liaison with sponsors, principal investigators, study team members, and the IRB to support the successful conduct of research projects.

Primary Functions

• Provide primary administrative support for the preparation of IRB documents. Assist in drafting and submitting protocols, protocol summaries, amendments, protocol deviations, serious adverse events, continuing progress reports, and consent documents. Modify documents as needed to meet IRB guidelines and research program requirements.

• Prepare and submit required documents in the institution's electronic IRB system for initial approval, amendments, and continuing progress reports. Review submissions for accuracy, completeness, and compliance using established checklists prior to submission.

• Support faculty with Investigator-Initiated IND/IDE applications. Maintain IRB and FDA regulatory files for each IND/IDE and ensure required routine monitoring is conducted.

• Facilitate study start-up activities, including submissions to committees such as the Scientific Review Committee, Data Safety Monitoring Board, Institutional Biosafety Committee, or Radiation Safety Committee. Manage ClinicalTrials.gov postings as required.

• Collaborate with Research Managers, Research Nurses, and Research Coordinators to identify and complete all regulatory needs for assigned protocols.

• Identify and resolve problems or obstacles related to research protocol implementation. Communicate issues to supervisors and study investigators.

• Ensure all regulatory activities comply with applicable federal and state laws, as well as institutional standard operating procedures.

• Assist investigators and research staff with the development of program materials, including educational materials, marketing content, websites, forms, and reports.

• Maintain program timelines by tracking deadlines for program components. Utilize the institution's Clinical Trial Management System (CTMS) to meet regulatory requirements and track activities. Collect, analyze, and disseminate program data, and report progress to stakeholders.

• Coordinate notifications to study team members regarding annual regulatory education requirements.

• Work with principal investigators to develop, implement, and maintain comprehensive databases and files related to the research program.

Preferred Schedule:



M-F, dayshift

Position Requirements:

Specifications

Appropriate experience may be substituted for education on an equivalent basis

Minimum Required Education: Bachelor's degree.

Minimum Required Experience: 2 years in compliance or healthcare field

Preferred Education:

Preferred Experience:

Field: Sciences or compliance, clinical research

Certification: CITI certification required within 30 days of hire. SoCRA and ACRP certification preferred.

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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