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 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 Assistant 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 Research Technician (Assistant) responsibilities: 

• Submits protocols, amendments, and continuing reviews to Institutional Review Board; files confidentiality agreements and works with sponsor to prepare study budgets.
• Completes paperwork and activities necessary in order to recruit, consent, and enroll human subjects in studies and trials. This will include, but not be limited to, searching and imaging medical records, photocopying, printing, and maintaining all documentation organized, secure, and current.
• Assures complete and correct scheduling of human subject visits, tests, and events with correct timing per protocol.
• Collects, organizes, and securely enters data into local or centralized databases, including data from source documents, labs, radiology, history and physicals, and other events.
• Collects and manages patient and laboratory data for clinical research projects. Screens and has oversight for the recruitment of subjects, supervises the scheduling of experiments and the collection, processing and analysis of data. Collects specimens and monitors subjects. Assists in the reporting of test results.
• Coordinates study visits with Clinical Trials Units. Performs phlebotomy and/or assures blood and urine collection by other staff occurs per protocol. Processes samples and prepares for storage or shipment. Prepares lab kits and shipping documents.
• Training new personnel in study procedures and job duties; assists with distributing workload from various clinical trials to team members.

SUPERVISION RECEIVED: This position received direct supervision and should report directly to a Clinical Research Coordinator Lead, Clinical Research Project Manager, Administrator, or Faculty Principal Investigator

SUPERVISION EXCERCISED: None

Clinical Research 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.  

Clinical Research Assistant

• High school diploma or GED is necessary.

Clinical Research 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. 

Clinical Research Assistant:

• Associate 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. 

Both: 

• Prior experience with clinical specimen collection and processing as well as institutional review board submissions.
• Health sciences training or training in clinical research; prior experience as clinical research coordinator preferred.
• Experience in training junior personnel and distribution of labor within clinical research team.

This is a full-time position, M-F, 40 hours. Onsite work is required. 

This position may be underfilled at the CRC-Assistant title 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. 

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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