Job Summary

This position may provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex. Coordinator experience and mastery of all job duties from previous job description is required. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all of their skills and abilities resulting in high quality work. It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency. This position can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.

Responsibilities*

Characteristic Duties and Responsibilities:
Independent knowledge, skills, and abilities within 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:

This position will handle clinical patient enrollment, administering of patient reported outcome surveys, transfer of biospecimens from clinic/OR to the lab, and maintenance of human subjects database

Required Qualifications*

    CRC Associate:

• Bachelor's degree in Health Science or an equivalent combination of related education and experience.
• 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)
• 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 qualifying experience prior to applying.
• Training requirements:
  • PEERRS, HIPAA, CITI GCP. 
  • eRPM Regulatory training. 
  • Attends and participates in all training assigned to this level. 

     CRC Technician:

• Associate degree in Health Science or an equivalent combination of related education and experience.
• ONE of the following:
  • Minimum 1 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.
  • 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.
  • 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.
• Training Requirements:
  • 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. 

Desired Qualifications*

• Bachelor's degree in Health Science. 
• Experience with REDCap.
• Experience enrolling patients and providing informed consent. 
• Experience administering patient surveys. 
• Experience with clinical studies (not necessarily clinical trials). 
• An understanding of medical terminology, experience in large complex health care setting.
• Ability to effectively communicate with staff, patients.
• Knowledge of university policies and procedures is desirable.
•  An understanding of medical terminology.

Work Schedule

This position will primarily support work Monday-Friday 8:00am-4:30pm.

Modes of Work

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.

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 any time after the minimum posting period has ended.

U-M EEO/AA Statement

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