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JOB REQUIREMENTS: Position Description: 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. Purpose Coordinate the day-to-day administrative activities of the clinical research trials program, including mentoring Research Regulatory Specialists with a focus on study activation. Duties include gathering regulatory documents, and preparing review committee submissions. Assists with amendments and continuing review for human subjects research as needed. Ensure 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. All remote work must be performed within one of the MCW registered payroll states, which currently includes: WI, AZ, FL, IL, IN, MD, MI, MN, MO, NC, TN,TX, and UT. Primary Functions * Prepare and/or provide guidance to Regulatory Specialists to prepare multiple Internal Review Board (IRB) documents. * Draft and submit protocols, protocol summaries, and consent-to-treat documents with minimal supervision. Following IRB guidelines, draft and/or modify documents as required by research program activities. * Assist as needed with submission of amendments, protocol deviations, serious adverse events, and continuing progress reports. 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 and amendments, and continuing progress reports as needed. 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... For full info follow application link. EEO/AA Minorities/Females/Vets/Disability The Medical College of Wisconsin is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, veteran status, disability or sexual orientation. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/7EBC06C071DB401D Qualified females, minorities, and special disabled veterans and other veterans are encouraged to apply.