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.

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
    

Responsibilities: 

• Assist study team with aspects of clinical research coordination including:  identifying potential subjects, screening subjects, consenting and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects. 
• Collect specimens and monitor study subjects.  Assist in monitoring of test results.  Ensure integrity of specimens (collection, processing, shipping/packing, storing, labeling, tracking, etc.).  
• Perform data management and results reporting, such as entering information into Case Report Forms (CRFs).  Assist with collection of external medical records for study reporting purposes. Ability to identify and report Adverse Events (AEs) and Serious Adverse Events (SAEs).
• Prepare IRB submissions including the initial applications, as well as amendments and scheduled continuing reviews, progress reports, safety reports, and adverse event reports.  
• In coordination with other M-CTSU staff, communicate with sponsors concerning progress of clinical trials, 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. Serve as key resource to research participants and collaborators.  Provide support for audits and monitor visits.
• Work collaboratively with the M-CTSU team by maintaining a good rapport and communication with research teams and faculty, as well as patients and families.
• Prepare and organize space for study related materials and equipment.
• The person in this position will frequently traverse around the medical campus and will occasionally spend long hours (full days) on their feet. There is a need to move, transport, and position clinical research supplies weighing up to 50 pounds across the hospital campus.
• Staff members are expected to work independently and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while always maintaining the strictest of confidentiality.
• This person may help mentor and train other CRC staff through formal and informal presentations.
• Other administrative responsibilities as assigned.

Supervision Received:
This position receives direct supervision and reports directly to the unit Administrator, CRC-Lead, or CRC-Project Manager.

Supervision Exercised:
None.
 

• Associate?s Degree or equivalent in combined education and clinical research experience

• Minimum of 1+ years direct related experience OR advanced degree in health-related areas OR 3 years of related human subjects experience.

   

   

  Underfill requirement
   

• High School Diploma or GED
   

• Bachelor?s Degree in Health Science or an equivalent combination of related education and experience is desirable
• An understanding of medical terminology preferred
• Knowledge of Michigan Medicine policies and practice
• Familiarity with OnCore, Epic, MiCHART, and eResearch applications
• PEERS, CITI, or NIH Protection of Human Subjects Training Certification
• Experience with local and central IRB application processes
   

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.

This position will primarily work M-F during normal business hours.

This position may be underfilled at the CRC-Assistant (103921) title based on selected candidates? qualifications.

The University of Michigan is an equal employment opportunity employer.