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Medical College of Wisconsin · 10 hours ago

Senior Research Regulatory Specialist - Cancer Center - 100% remote

United States

Full-time

Remote

Mid, Senior Level

$64K/yr - $81K/yr

4+ years exp

Medical College of Wisconsin is seeking a Senior Research Regulatory Specialist to coordinate the administrative activities of the clinical research trials program. The role involves mentoring staff, ensuring compliance with regulations, and acting as a liaison among various stakeholders in the research process.

EducationHigher EducationMedical

Responsibilities

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, occasionally prepare and/or provide guidance to Regulatory Specialists for drafting/modifying IRB 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, Research Coordinators, and all other study team members to identify, prioritize, and complete all regulatory needs associated with each assigned protocol – including annual regulatory education requirements. 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, databases, 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

Identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicate proposed solutions or process improvements to supervisor and study investigators

Manage special projects as assigned by Manager and/or CTO Leadership with minimal supervision

Other duties as assigned

Qualification

Regulatory complianceClinical trial managementCITI certificationData utilizationCritical thinkingResource managementOral communicationWritten communicationProblem solvingAttention to detail