Research Regulatory Specialist - Pediatric Hematology / Oncology / BMT

Overview

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 be working in our Pediatrics Department. This role is part of the MACC Fund Research Regulatory team, responsible for preparing regulatory documents, preparing IRB / CIRB applications, IND / IDE applications, protocol amendments and continuing review for human subject research ensuring compliance with Federal, State and Institutional Standard Operating Procedures. This Research Regulatory Specialist will function as the regulatory liaison between principal investigators, sponsors, study team members and regulatory agencies (IRB, FDA).

Primary Responsibilities

• 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 informed consent documents. Following IRB guidelines, draft and / or modify documents as required by research program activities.
• Prepare the required documents in the MCW and / or CHW electronic IRB system for initial approval, amendments and continuing progress reports. Review for accuracy and completeness and identify problems prior to IRB submission
• Facilitate regulatory start up activities, as necessary, including but not limited to, Data Safety Monitoring Board (DSMB), Institutional Biosafety / Radiation Safety Committee, and ClinicalTrials.gov postings.
• Work closely with Research Leadership and study teams to identify and complete all regulatory needs associated with each assigned protocol.
• Develop and formalize Quality Assurance process for internal audits of research charts / records. Identify problems or obstacles in the system / procedures related to implementation of the research protocols and communicate to supervisor and study investigators. Attend all internal / external audits (MCW, Sponsor, FDA, etc).
• 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.
• Assure that the regulatory activities comply with various federal and state regulations, and institutional standard operating procedures.
• Develop and maintain departmental Standard Operating Procedures for research-related activities.
• Maintain program timeline including tracking deadlines for program components. Utilize OnCore 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 notifications to all study team members regarding annual regulatory education requirements (i.e. CITI, Radiation Safety, etc.). Maintain investigator NCI-registration as necessary.
• Work with Principal Investigators to develop, implement, and maintain comprehensive databases and files related to the program.
• Collaborate with investigators and research teams on the development of program materials including educational materials, marketing materials, websites, forms, and reports.
• Perform other duties as assigned.

Knowledge – Skills – Abilities

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