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.