What are the responsibilities and job description for the Pediatric Clinical Trials Office (CTO) Research Regulatory Specialist position at Medical College of Wisconsin?
The Medical College of Wisconsin (MCW) 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 a Research Regulatory Specialist you will beworking in ourPediatrics Deaprtment.
Purpose
Member of the 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 Specialist will function as the regulatory liaison with sponsors, principal investigators, study team members and the IRB providing support to facilitate the achievement of the CTO’s goals.
Primary Functions
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 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.
Facilitate study start up activities, as necessary, including : submissions to Scientific Review Committee (SRC), Data Safety Monitoring Board (DSMB), Institutional Biosafety / Radiation Safety Committee, and postings.
Work closely with CTO Research Managers, Research Nurses, 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 CTO 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 Principal Investigator to develop, implement, and maintain comprehensive databases and files related to the program.
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.
