Illinois
Chicago, IL-Hybrid Workplace
Posted: 18-Nov-23
Location: Ann Arbor, Michigan
Salary: Open
Internal Number: 241802
A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
This position is located within a sports medicine research and clinical musculoskeletal research lab that currently focuses on clinical trials, epidemiology, outcomes, and genetics research on patients with rehabilitation and orthopedic conditions such as rotator cuff tears that cause shoulder pain. There are several ongoing multi-center studies ongoing including: cuffGEN which is a multi-center cohort study on genetic epidemiology of rotator cuff tears and treatment; ARC which is a multi-center randomized clinical trial on operative versus non-operative treatment for rotator cuff tears. Additional information on our studies can be found at the website shoulderstudy.org.
The ideal candidate will have experience in management of multi-center studies/clinical trials and strong interpersonal, communication, and project management skills, as well as be comfortable interacting with individuals at all levels of clinical research - from research and hospital administration to patients enrolled in the study. This group works extensively with REDCap databases, so knowledge and experience working with REDCap is strongly preferred. The candidate will also liaison with grants management on drafting budgets and budget justification, and work with department and institutional administration on expense/cost center management and keeping track of ledgers and expense allocation. They will also help with grant submissions and with administrative components of multi-center grants. The individual should be able to manage a team of coordinators and provide them with guidance. They will manage the research team.
Our group mainly performs clinical research (clinical trials, cohort studies, and big data studies). We have limited wet lab research projects. The ideal candidate will have experience in clinical research settings.
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:
1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. Communication and Teamwork
This individual will provide administrative supervision of three staff, two in titles within the CRC Career Ladder. This position manages a portfolio of multi-site clinical research in which the University of Michigan is the lead center.
Lab Management (40%)
- Coordinates duties, schedules, project activities, equipment usage, operating time, research studies, billing, and space for large group of people ensuring efficient operation of lab. 20%
- Coordinates availability of technical assistance and special equipment to ensure timely preparation or completion of clinical work or research projects. 15%
- Orders and allocates all laboratory supplies, materials, and equipment; maintains adequate inventory to ensure efficient operation of projects. 3%
- Maintains information on warranties, service contracts, operating manuals, licenses and permits; oversees maintenance of laboratory equipment in order to ensure compliance with all regulations and safety standards. 2%
Study Management - Local Projects (10%)
- Compiles, analyzes, and presents research data using computers and subledgers for submission to investigators to be used in preparation of journal articles for publication. Prepares journal articles and writes protocols for research as required by organizing and editing data. Responsible for maintaining regulatory compliance and documentation for potential audits (10%)
Study Management - Multi-Site Projects (25%)
- Compiles, analyzes, and presents research data using computers and subledgers for submission to investigators to be used in preparation of journal articles for publication. Prepares journal articles and writes protocols for research as required by organizing and editing data. Responsible for maintaining regulatory compliance and documentation for potential audits 10%
- Provides direction and oversight to study teams at external, participating sites 15%
Staff Management (25%)
- Supervises laboratory and office personnel, maintains personnel records, completes performance evaluations, and recruits and trains both clerical and technical support using managerial skills according to departmental and university guidelines. 20%
- Troubleshoots problems and designs training according to government regulations. 5%
Supervision Received
This position reports directly to the faculty principal investigator.
CRC Project Manager
- Master's Degree in Health Science or an equivalent combination of related education and experience.
- 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 and must be achieved by 01/01/24. After 01/01/24, certification is required within six months of date of hire.
- Minimum 6 years of directly related experience in clinical research and clinical trials.
CRC Lead
- Bachelor's Degree in Health Science or an equivalent combination of related education and experience.
- 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 and must be achieved by 01/01/24. After 01/01/24, certification is required within six months of date of hire.
- Minimum 5 years of directly related experience in clinical research and clinical trials.
- Project Management certification.
- 9+ years of direct related experience.
Monday - Friday, with variability depending on the needs of study participants and site coordination.
This position may be underfilled at the CRC-Lead title based on selected candidates' qualifications and the review and approval of the Michigan Medicine CRC Governance Board.
This is a term-limited position with funding available through August 31, 2026, with an extension possible.
The Physical Medicine and Rehabilitation Department within Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.
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.
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 anytime after the minimum posting period has ended.
The University of Michigan is an equal opportunity/affirmative action employer.