Address
Form of workThe 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 Research Regulatory Specialist Senior you will beworking in the Cancer Center.
Purpose
Coordinate the day-to-day administrative activities of the clinical research trials program, including mentoring Research Regulatory Specialists, gathering regulatory documents, preparing review committee submissions, amendments and continuing review for human subject research ensuring compliance with Federal and State regulations, institutional policies, and Standard Operating Procedures. Perform as the regulatory liaison between sponsors, principal investigators, study team members, and review committees. Facilitate the achievement of the Cancer Center CTO goals. Lead a team of Research Regulatory Specialists and/pr Coordinators.
Primary Functions
• Prepare and/or provide guidance to Regulatory Specialists to prepare multiple Internal Review Board (IRB) documents.
• Draft and submit protocols, protocol summaries, amendments, protocol deviations, serious adverse events, continuing progress reports, and consent-to-treat documents with minimal supervision. Following IRB guidelines, draft and/or modify documents as required by research program activities.
• Prepare and/or provide guidance to 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.
• Coordinate support for Investigator-Initiated IND/IDE applications; maintain IRB and FDA regulatory files for each IND/IDE and ensure routine monitoring is conducted as required.
• Manage study start up activities, as necessary, including submissions to Scientific Review Committee (SRC), Data Safety Monitoring Board (DSMB), Institutional Biosafety Committee, Radiation Safety Committee, MRI Committee, and ClinicalTrials.gov postings.
• Advise CTO Research Managers, Research Nurses, and Research Coordinators to identify, prioritize, and complete all regulatory needs associated with each assigned protocol.
• Manage program timelines including tracking deadlines for program components.
• Mentor and advise others on matters of research administration, research administration systems, processes, and regulations.
• Manage special projects as assigned by Manager and/or CTO Leadership with minimal supervision.
• 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
Knowledge of biology, chemistry, mathematics, documentation, regulatory compliance, interpretation of regulations, and records management.
Oral and written communication skills.
Critical thinking, problem solving, and attention to detail.
Data utilization and resource management.
#LI-AV1
