Responsibilities*

Knowledge of all 8 competency domains is expected and experience within applicable domains specific to unit
needs.

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

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 - Technician and/or Assistant position is required.

Additional duties include:

• Screens and oversees the recruitment of subjects, coordinates the scheduling of research procedures and the collection of research specimens, processing and analysis of data, and monitors subjects.
• Oversees IRB preparation and submission for studies, and for patient consenting and enrollment.
• Collaborates with Sleep and Epilepsy faculty, support teams, and stakeholders to ensure the development and
• implementation of consistent system standards. Uses existing procedures to solve routine or standard problems.

Required Qualifications*

Clinical Research Coordinator Associate

• Bachelor?s degree in Health Science or an equivalent combination of related 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 SoCRA?s Definition of a Clinical Research Professional for qualifying experience prior to applying.)  

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 SoCRA?s 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
• 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.
  Bachelor?sequivalenteducationerienc

Desired Qualifications*

Clinical Research Coordinator Associate

• 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 Technician

• Bachelor's degree or equivalent in combined education and clinical research experience
• 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's degree or equivalent in combined education and clinical research experience
• 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

Work Schedule

Preferred working hours are 9:30/10 - 6/6:30 pm; exact hours will be discussed with the candidate prior to offer/acceptance

Underfill Statement

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

Background Screening

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.

Application Deadline

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.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.