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 clinical research coordinator (CRC) position with the Department of Anesthesiology, Chronic Pain and Fatigue Research Center may provide study coordination for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the CRC-Intermediate position on the Michigan Medicine CRC Career Ladder is required, including experience with various committees at the University. This position gives back to the institution through mentoring others on study management and participating in training and development of junior clinical research professionals.  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 level of CRC develops 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. Key behavioral competency descriptors include: Design, develop, evaluate, guide, mentor, and support.

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

• 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
• Trains and supports study team members
• Document study progress
• 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
• Facilitate communication between study teams.
• Perform Quantitative Sensory Testing (QST) and willingness to be trained, inside and outside of MRI
• 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

Supervision Received:

This position reports directly to the Administrative Manager of center

Supervision Exercised:

Possibly provide Functional supervision, in a limited capacity, such as training of staff in titles within the CRC Career Ladder.

CRC Senior:

• 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. 
• Excellent attendance and strong work ethic in past settings
• Demonstrate ability to work successfully while meeting competing deadlines
• Excellent interpersonal skills
• Demonstrated ability to prioritize and exercise good judgement
• Proficient with eResearch
• Attention to detail and accuracy

CRC Intermediate:

• 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. 
• Excellent attendance and strong work ethic in past settings 
• Demonstrate ability to work successfully while meeting competing deadlines
• Excellent interpersonal skills
• Demonstrated ability to prioritize and exercise good judgement
• Attention to detail and accuracy
• Familiar with eResearch

CRC Senior:

• 9+ years of direct related experience
• Phlebotomy experience
• Lab processing experience
• Survey and database creation in RedCAP, Qualtrics or MyDatahelps app.
• Experience with Actigraph

CRC Intermediate:

• 6+ years of direct related experience
• Phlebotomy experience
• Lab processing experience
• Survey creation in RedCAP, Qualtrics or MyDatahelps app.
• Experience with Actigraph

Monday-Friday with occasional evenings/weekends as needed.

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.

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.

U-M COVID-19 Vaccination Policy

COVID-19 vaccinations, including boosters when eligible, are required for all University of Michigan students, faculty and staff across all campuses, including Michigan Medicine.  This includes those working remotely.   More information on this new policy is available on the Campus Blueprint website or the UM-Dearborn and UM-Flint websites.