JOB REQUIREMENTS: Position Description: Every day, in ways both big andsmall, the Medical College of Wisconsin (MCW) is impacting lives for thebetter. MCW ... changemaking for a healthier Wisconsin. In the role ofa Research Regulatory Specialistyou will beworking in the Cancer Center.Purpose Member of the Cancer Center CTO Regulatory team responsible forgathering regulatory documents, preparing IRB applications, amendmentsand continuing review for human subject research ensuring compliancewith Federal, State and Institutional Standard Operating Procedures.This CTO Research Regulatory Specialist will function as the regulatoryliaison with sponsors, principal investigators, study team members andthe IRB providing support to facilitate the achievement of the CancerCenter CTO\'s goals. Primary Functions1. Provide main administrativesupport for the preparation of multiple Internal Review Board (IRB)documents. Assist in drafting and submitting protocols, protocolsummaries, amendments, protocol deviations, serious adverse events,continuing progress reports, and consent-to-treat documents. FollowingIRB guidelines, draft and/or modify documents as required by researchprogram activities. 2. Prepare the required documents in theMCW/Froedtert electronic IRB system for initial approval, amendments andcontinuing progress reports. Review for accuracy and completeness,identify problems, and perform quality control based on establishedchecklists prior to IRB submission. 3. Support faculty withInvestigator-Initiated IND/IDE applications; maintain IRB and FDAregulatory files for each IND/IDE and ensure routine monitoring isconducted as required. 4. Facilitate study start up activities, asnecessary, including submissions to Scientific Review Committee (SRC),Data Safety Monitoring Board (DSMB), Institutional Biosafety/RadiationSafety Committee, and ClinicalTrials.gov postings. 5. Work closely withCTO Research Managers, Research Nurses, and Research Coordinators toidentify and complete all regulatory needs associated with each assignedprotocol. 6. Identify problems or obstacles in the system/proceduresrelated to implementation of the research protocols and communicate tosupervisor and study investigators. 7. Assure that the regulatoryactivities comply with various federal and state laws, and institutionalstandard operating procedures. 8. Collaborate with investigators and CTOResearch nurses/study coordinators on the development of programmaterials including educational materials, marketing materials,websites, forms, and reports. 9. Maintain program timeline includingtracking deadlines... For full info follow application link. EEO/AAMinorities/Females/Vets/Disability The Medical College of Wisconsin isan affirmative action/equal opportunity employer and does notdiscriminate in hiring or employment on the basis of age, sex, race,color, religion, national origin, veteran status, disability or sexualorientation. ***** APPLICATION INSTRUCTIONS: Apply Online:ipc.us/t/D44DCA45B1C74708 Qualified females, minorities, and specialdisabled veterans and other veterans are encouraged to apply.