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

Experience as part of a team with 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

• Performs moderately complex study procedures with accuracy.
• Triages simple subject concerns and issues appropriately.
• Assesses studies for execution and troubleshoots potential implementation issues.
• Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.
• Completes simple to moderately complex data collection during study visits.
• May work with CTSUs to reconcile financial accounts for study participants.
• Assists with local quality control efforts.
• May create a recruitment plan that addresses the needs of the study population and develop materials for IRB submission that will aid in recruitment

Data Coordinator Responsibilities 

• May work with Office of Research Compliance to create and post studies in ClinicalTrials.gov.  
• May obtain the CTN number for eResearch applications.
• Completes simple to moderately complex CRFs.
• Can resolve simple to moderately complex queries (e.g., data error changed numerous values in EDC)
• May assist in CRF development for Investigator Initiated trials.

Regulatory Coordinator Responsibilities 

• May complete new eResearch applications.
• May maintain essential regulatory documents as outlined in the ICH-GCP guidelines.
• May gather participant approval via informed consent. 
• Prepares and participates in internal and external audits.
• Demonstrates ability to manage increasing levels of protocol complexity or volume efficiently.
• Demonstrates ability to identify Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Events (ORIOs), and understands how to report appropriately.

Administrative Responsibilities 

• Demonstrates understanding of the clinical research objectives associated with the program.
• May communicate with study participants such as sending study correspondence via mail or email.
• May schedule subjects for research visits and FU appointments.
• May check study calendar for completion of study procedures.
• May manage study supply inventory.
• May utilize documents and systems to track recruitment and retention of participants.
• May complete and activate postings (advertisements, flyers, etc.) independently.
• May work with regulatory support to maintain regulatory binder (CVs, MD licenses, lab certifications, IRB rosters, UM lab norms, etc.)

Training

• All training requirements of previous level.
• PEERRS, HIPAA, CITI GCP
• Gains appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assigned.
• Willing to learn and use available technology and systems to accomplish job requirements.
• Understands the disease process per program.
• Attends and participates in all training classes assigned to this level. Assists with training activities of staff and others.

Supervision Received: CRC-Project Manager

Supervision Exercised: None

• 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. 

• 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.

This position requires employee to be on -site. Hours will typically reflect a standard day shift from 8:00 to 4:30 M-F, but some flexibility will be expected as the team will need to cover tasks that may fall on weekends or outside of standard day shift hours. 

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.

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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