This position will lead study coordination for multiple clinical research studies within the Division of Acute Care Surgery. Coordinator experience and mastery of all job duties from the Clinical Research Coordinator Intermediate position is mandatory.  

Characteristic Duties and Responsibilities:
Contribute to the development of process and tools 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
 

• Conduct of externally funded, multi-center Critical Care clinical trials, including cutting edge ICU ventilation trials within NHLBI PREVENT-VILI trial, ARDS interventional trials within the BARDA BREATHE ARDS platform and early detection and characterization of necrotizing fasciitis in the NIAID NEFARIOUS trial. Automotive institute trauma CT morphomics studies that would be funded through industry, rather than a federal mechanism.  Regulatory is likely covered under individual site IRBs rather than an SIRB.  Coordination between sites would include: intersite communication and regulatory assurance, data verification audit, management of limited data sets/image data handling, pooled analysis and reporting, possible sponsor interaction.  
• Development of new institutional multidisciplinary collaborative trials in sepsis
• Engagement and ownership through the clinical trials process, including the initial regulatory phase through execution and closeout
• Contribute as a key member of a multidisciplinary Critical Care collaboration
• Support regulatory efforts and facilitate research projects for faculty and fellows in the Division of Acute Care Surgery.  
• A commitment to excellence in clinical research is essential

The successful Candidate must be dynamic and self-motivated, looking to work in conjunction with PIs within Acute Care Surgery.  They will have direct oversight of clinical research projects, ensuring they are completed within specifications to a high level.  The position will be salaried and require flexible scheduling.

Duties include participation in all aspects of high-level federal and industry sponsored clinical investigation, including protocol evaluation, managing IRB submission and renewals, budget/billing calendar, screening/enrollment, trial execution, compliance, and adverse event reporting.   Additional participation in Network activities will include regular conference calls, interaction with other Michigan investigators and periodic trials meetings.  

The strong candidate will demonstrate commitment to excellence in clinical research, adhering to appropriate standards and guidelines and exceptional organizational skills.  As a member of a high-functioning team, the individual must have the ability to make independent decisions, free from immediate direction, within the scope of their responsibilities.  Team building skills and leadership will be highly valued.  Proficient use of computers and applications including Microsoft Word, Excel, PowerPoint, EndNote, University systems (MiChart, MBect) are required.  Finally, the candidate must be able to work in Acute Care environment and with potentially life-saving interventions in a critical care environment.
 

Related Duties
Responsible for recommendations on workload assessments and distribution
 

Supervision Received
This position should report directly to a Faculty Principal Investigators and Division Administrator

Senior Requirements

• CRC Governance Committee review and approval
• Bachelor'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 of directly related experience in clinical research and clinical trials is necessary. 
• (Please review SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.)  

Intermediate Requirements

• Bachelor'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 3 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.

• 9+ years of direct related experience
• Masters Degree in Health Science or an equivalent combination of related education and related experience is desirable

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.

40 hours with flexibility.  Onsite requirements based on need of clinical studies with possible weekend coverage

This position may be underfilled at the CRC-Intermediate title based on selected candidates qualifications and the review and approval of the Michigan Medicine CRC Governance Board.

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.

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 any time after the minimum posting period has ended.

The University of Michigan is an equal employment opportunity employer.