Job Description

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 depending on complexity that range from moderate to complex. Coordinator experience and mastery of all job duties from the CRC-Associate position on the Michigan Medicine CRC Career Ladder is required. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work. It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency. This position can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.

Independent knowledge, skills, and abilities within 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 Research Coordinator Associate

• Participant Screening and Recruitment
• Explaining study thoroughly, reviewing informed consent, answering any questions, following GCP/IRB and obtaining consent.
• Demonstrates understanding of protocol elements/requirements and demonstrates the ability to execute study procedures.
• Demonstrates the ability to anticipate and mitigate the potential for protocol non-compliance.
• Demonstrates the ability to document data in accordance with ALCOA-C principles.
• Describes protocol structure and explains how to interpret study requirements to ensure study compliance.
• Demonstrates accurate implementation of protocol procedures.
• Explains and performs study related management activities.
• Performs study procedures with minimal supervision.
• Triages subject issues appropriately.
• Schedules and runs study visits with complex data collection.
• Perform Quantitative Sensory Testing (QST) inside and outside of MRI, and willingness to be trained
• Preparation datasheets, questionnaires, study related documents
• Tracking and communication with study subjects
• Complete subject documentation and follow up 
• Assist with data entry and capture
• Ensures integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.).
• Comfortable with basic clinical lab equipment such as a centrifuge, various freezers, pipettes, and standard laboratory safety requirements and guidelines.
• Submit Human Subjects Incentive Program (HSIP) requests
• Assist with eResearch submissions

Clinical Research Coordinator - Technician

This position provides study coordination for simple and moderately complex clinical research studies. As a member of the research team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the Clinical Research Assistant position is required.

• Performs moderately complex study procedures with accuracy.
• Tracking and communication with study subjects
• Triages subject concerns appropriately.
• Assesses studies for execution and troubleshoots potential implementation issues.
• Completes simple to moderately complex data collection during study visits.
• Assists with local quality control efforts.
• Submit Human Subjects Incentive Program (HSIP) requests
• Assist with data entry and capture

Clinical Research Coordinator - Assistant

This is an entry level position that provides administrative and coordination support for multiple projects in the conduct of clinical research projects. This position may assist with study coordination but will not be assigned clinical trials independently. Demonstrates the ability to screen participants for study eligibility.

• Performs study procedures with accuracy.
• Tracking and communication with study subjects
• Understands protocol structure and how to interpret study requirements to ensure study compliance.
• Understands proper documentation techniques, as outlined in the ICH-GCP guidelines.
• May assist research coordinator in conduct of SIV; attends SIV.
• May assist in and attend monitor visits and/or audits.
• Submit Human Subjects Incentive Program (HSIP) requests
• Assist with data entry and capture

Supervision Received: This position reports directly to the Admin Manager.

CRC Associate:

• Bachelors degree in Health Science or an equivalent combination of 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 2 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.)
• Attention to detail and accuracy
• Excellent attendance and strong work ethic in past settings
• Excellent interpersonal skills
• Demonstrated ability to prioritize and exercise good judgement

CRC Technician:

• Associate degree in Health Science or an equivalent combination of related education and experience is necessary. 
• Minimum 1 year 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.)  or An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD. or Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research. 
• Attention to detail and accuracy
• Excellent attendance and strong work ethic in past settings
• Excellent interpersonal skills
• Demonstrated ability to prioritize and exercise good judgement

CRC Assistant:

• High School Diploma
• Attention to detail and accuracy
• Excellent attendance and strong work ethic in past settings
• Excellent interpersonal skills

CRC Associate:

• 4+ years of direct related experience
• Phlebotomy Experience
• Lab processing experience
• Experience with eResearch

CRC Technician:

• Bachelors Degree in Health Science or an equivalent combination of related education and experience is desirable.  An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.

CRC Assistant:

• Associate Degree in Health Science or equivalent combination of education and experience is desirable. An understanding of medical terminology, experience in a large medical complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.

Monday-Friday with occasional evenings/weekends as needed.

This position may be underfilled at the CRC-Technician or CRC-Assistant titles based on selected candidates qualifications.

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.

This position is term-limited for about 3 years (ending May 2027) with the possibility of renewal based on need and available funding. At the end of the stated term, your appointment will terminate, and will not be eligible for Reduction-in-Force (RIF) benefits. This term-limited appointment does not create a contract or guarantee of employment for any period of time as you will remain subject to disciplinary or other performance measures, up to and including termination, at the will of the University in accordance with existing University policy and standards for employee performance and conduct.

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.

About University of Michigan - Ann Arbor

A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.

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Job Tags

Contract work, Local area, Afternoon shift, Monday to Friday,

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