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 CRC-Assistant position on the Michigan Medicine CRC Career Ladder is required.

Characteristic Duties and Responsibilities:

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

We are seeking a motivated clinical research professional who enjoys patient-oriented, collaborative translational science and desires to contribute to research in a team-based environment. The Clinical Research Coordinator will join the translational research team led by Dr. Jessica Turnier within the growing Pediatric Rheumatology Research Program at the University of Michigan. Dr. Turnier is a Pediatric Rheumatologist, and her research focuses on understanding the biochemical and cellular pathways underlying skin and systemic inflammation in juvenile myositis and lupus. Dr. Turnier?s lab applies molecular and bioinformatic approaches to analysis of biosamples from a longitudinal cohort of juvenile myositis and lupus patients to better understand treatment response and develop novel therapeutic targets and biomarkers. 
 

The Pediatric Rheumatology Clinical Research Coordinator will play a central role in the delivery of high-quality results in the following key responsibilities: 
Prepare, manage, and organize space for study related materials and equipment to accomplish the following:

• Identify, screen and enroll potential subjects; consent minimal risk subjects
• Perform data management, such as entering information into Case Report Forms (CRFs)
• Work collaboratively with the CTSU team by maintaining a good rapport and communication with research teams and faculty, as well as patients and families
• Coordination of multicenter study and patient engagement efforts

Collect and manage patient and laboratory data for clinical research subjects

Collection of patient bio specimens and disease activity measures; maintain oversight to ensure integrity of specimens (collection, shipping/packing, storing, labeling, tracking, etc).

Processing of patient bio specimens including:

• Centrifugation, cell isolation, and freezing of patient specimens
• Labeling and tracking of samples in Freezer works

Assist with developing and writing Abstracts/Manuscripts and/or Clinical Trials Protocols.

Support the preparation for IRB audit and monitor:

• Assist in the preparation of IRB applications, amendments and scheduled continuing reviews, progress reports, safety reports and adverse event reports
• In coordination with other CTSU staff, communicate with sponsors concerning progress of clinical research, billing calendar/budget issues, subject related problems, recruitment strategies, and specific policies and procedures
• Act as liaison between study team and sponsors, IRB, federal, state, and University officials and other regulatory agencies to maintain accurate communication of costs, policy changes, fiscal requirements, and other regulatory issues
• Assist in the training of other research staff in the research program 

Supervision Received:

This position receives direct supervision and reports directly to (a CRC-Lead, CRC-Project Manager, a unit Administrator, Director, or Faculty Principal Investigator).

Supervision Exercised:

None.

• Excellent interpersonal, oral, and written communication skills
• Proficient computer skills including Microsoft software applications
• Ability to organize/prioritize tasks effectively and efficiently
• Demonstrated ability to manage work across a set of diverse stakeholders (e.g., study subjects, research assistants, research investigators, regulatory staff/agencies)
• Ability to set goals, exercise sound professional judgment, and problem-solve within delegated authority
• Ability to work independently to meet milestones and deadlines
• Solid attendance record and work ethics

Technician Level: 

• 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;
  
  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

Assistant Level: 

• High school diploma or GED is necessary.

• Bachelor’s 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
• Experience and understanding of pediatric clinical research and Rheumatology patient care
• Experience with the University of Michigan eResearch system
• Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) certification
• Experience of participating in the writing manuscripts and progress reports
• Demonstrated good judgment and strong problem solving skills related to clinical research experience
• Good understanding of medical terminology
• Familiarity with REDCap, OnCore, Epic, MiChart, and eResearch applications
• Some knowledge of UMHS policies and practice
• Proven experience in administering IRB/regulatory requirements and protocols

The position is full-time. The work schedule will typically be Monday-Friday, 8-hour shifts. However, flexibility on weekends and evenings may be required depending on study needs.

This position may be underfilled at the CRC-Assistant title based on selected candidates’ qualifications.

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 employment opportunity 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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