The clinical research coordinator (CRC) position will provide study coordination for multiple clinical research studies of varying complexity for the Scleroderma Program in the Division of Rheumatology. We anticipate this will be 50% of the position. For other 50%, the CRC will provide oversight of the scleroderma portfolio and provide mentorship and guidance to the junior clinical research professionals on study management as well as training and development.  This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and mentor study team members in the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This CRC will develop new processes, procedures, tools, and training to enhance clinical research activities across the competency domains. This position continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. 

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

Clinical Coordinator Responsibilities
The position is looking to hire a coordinator with expertise in conducting pharmaceutical-funded clinical trials.

• Participant Screening and Recruitment
• Explaining study thoroughly, reviewing informed consent, answering any questions, following GCP/IRB and obtaining consent 
• Demonstrates ability to triage complex study concerns appropriately 
• Schedules, prepares for, and attends study initiation meetings, IMC meetings, monitor visits, and audits 
• Demonstrates ability to manage increasing levels of protocol complexity and/or volume efficiently 
• Collection of patient bio specimens and disease activity measures; ensure integrity of specimens (collection, processing, shipping/packing, storing, labeling, tracking, etc).
• Various duties as needed 

Study Interactions and Collection

• Attain in-depth understanding of study protocol and objectives to assist with successful implementation of all study procedures 
• Demonstrates the ability to create CRFs, study documents, and tools 
• Demonstrates ability to resolve complicated queries 
• Scheduling and completing subject visits or follow up interactions 
• Preparation datasheets, questionnaires, study related documents 
• Tracking and communication with study subjects 
• Complete subject documentation and follow up 
• Specimen handling, process lab samples, manage laboratory samples and shipping 
• Submit Human Subjects Incentive Program (HSIP) requests 

Data Entry and Cleaning

• Assist with data entry and capture 
• Responsible for data entry and management for study 
• Chart abstractions of data to enter in database(s) and source documentation 
• Demonstrates ability to resolve complicated queries. 
• Takes an active role in ensuring data quality. 
• Review collected data and perform data quality assurance of the collected data with the study monitor 
• Demonstrates expertise in data collection, data management, and results reporting. 
• Various duties as needed 

Regulatory

• Prepare Institutional Review Board research applications and reporting; update and maintain IRB records 
• Facilitate monitoring visits on regulatory compliance 
• Facilitate Independent Monitoring Committee meetings 
• Add new clinical trials and update existing clinical trials at Clinicaltrials.gov. 
• Working with Research Pharmacy, study medication and chain of custody 

Supervisory Role

• Supervise study coordinators for upcoming and ongoing clinical trials. 
• Hire and trains and supports study team members 
• Facilitate communication between study teams.
• Provide guidance and study coordinators and research assistants: team leader, mentor, delegate projects and handle conflicts. 
• Serve as liaison for Program Director and scleroderma clinicians.
• Develop and maintain program training and procedures
• Other duties as assigned 
   

Supervision Received: This position reports directly the Faculty Principal Investigator.

Supervision Exercised: Could provide Functional supervision (likely in limited capacity such as training) of staff in titles within the CRC Career Ladder.

Senior Level:

• 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) 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 is necessary. 

Intermediate Level:

• 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) and must be achieved by 01/01/24.  After 01/01/24, certification is required within six months of date of hire. 
• Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. 

Senior Level:

• 9+ years of direct related experience

Intermediate:

• 6+ years of direct related experience

This position will be mostly in-person with an expectation of 4-5 days per week onsite. 

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 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.

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally.  Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

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.

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