Characteristic Duties and Responsibilities:

Set up unit wide systems or policies and manage a team of clinical research professionals (or portfolios) in all 8 competency domains is expected: Scientific Concepts and Research Design Ethical Participant Safety Considerations Investigational Products Development and Regulation Clinical Study Operations (GCPs) Study and Site Management Data Management and Informatics Leadership and Professionalism Communication and Teamwork Lead all aspects of an NIH sponsored multi-site investigator initiated trial encompassing 10-15 sites Develop all necessary essential study documents, tools, manuals, processes etc. Facilitate DSMB review for the project and participating sites Serve as primary point of contact for study-related issues and needs Onboard participating sites by facilitating contract execution and registry access Train participating sites in study related procedures and data collection Manage data quality for participating sites Liaise with biostats support regarding aims of project and analysis Conduct project meetings that include participating sites Support other sponsored trials by: Consenting and enrolling participants Performing study visits Collecting necessary data Working with sponsors, CROs, and lab to ensure complete and accurate data collection, safeguard patient safety, and facilitate high quality study operations.

Administrative duties:

Working with and mentoring other CRCs supporting the program portfolio; functional or administrative supervision of staff in the future is a possibility. Assisting with planning/scheduling program meetings as needed Sit in on financial meetings and work to conceptually understand impact of financial decisions Complete all necessary training required by institution, networks, sponsors etc. Other duties as assigned and/or agreed upon with Program Director Required Qualifications• CRC Governance Committee review and approval Master's degree in health science or an equivalent combination of related education and experience is necessary. Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire, and the certification must be completed or passed etc. within six months of date of hire. (Please review eligibility criteria from SoCRA or ACRP prior to applying.) Minimum 5 years (Senior/Lead) to 6 years (CRC-PM) of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA's Definition of a Clinical Research Professional for qualifying experience prior to applying.) Desired Qualifications• Project Management certification Experience with NIH funded trials Experience with multi-center investigator initiated trials 9+ years of direct related experience Why Join Michigan Medicine? Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world's most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good. What Benefits can you Look Forward to? Excellent medical, dental and vision coverage effective on your very first day 2:1 Match on retirement savings Modes of Work Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes. Work Schedule This position is hybrid, with at least 2-3 days/wk onsite work regularly in Ann Arbor, MI •required•. Work hours are Monday to Friday from 8:00 am to 5:00 p.m. There will be some travel to national meetings. Underfill Statement This position may be underfilled at the CRC-Lead or CRC-Senior titles based on selected candidates' qualifications and the review and approval of the Michigan Medicine CRC Governance Board.

Additional Information Supervision Received:

This position reports directly to a Faculty Principal Investigator.

Supervision Exercised:

None at this time The use of this title requires approval by the University of Michigan Clinical Research Coordinator Governance Board to ensure equity in title placement across Michigan Medicine. Background Screening Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses. Application Deadline Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled any time after the minimum posting period has ended. U-M EEO Statement The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities. Job Opening

ID 280573

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Clinical Research Project Manager (underfill CRC Lead, CRC Senior)