Job Summary

The Center for Clinical Outcomes Development and Application (CODA) in the Department of Physical Medicine and Rehabilitation is seeking an energetic, enthusiastic individual who is excited to expand their clinical research knowledge and skills to join our growing research team. The successful candidate will work closely with the center director and other study team members to execute, coordinate and support the center's large portfolio of clinical research studies and behavioral trials across several diverse clinical populations (e.g., Alzheimer's disease, Huntington disease, spinal cord injury, traumatic brain injury, caregivers).

This position will provide study coordination for clinical research studies. Mastery of all job duties from the CRC-Assistant position on the Michigan Medicine CRC Career Ladder is required for the CRC-Technician position. Coordinator experience and mastery of all job duties from the CRC-Technician position is required for the CRC-Associate position. 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 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.

Responsibilities*

Characteristic Duties and Responsibilities:

Independent knowledge, skills, and abilities within the competency domains below is expected:

1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Clinical Study Operations (GCPs)
4. Study and Site Management
5. Data Management and Informatics
6. Leadership and Professionalism
7. Communication and Teamwork

Specific Responsibilities for this Position Include:

• Conducting study start-up activities (creating participant materials, creating study case report forms [CRFs] and other documents, preparing training materials, ordering study supplies, programming and testing data collection platforms, etc.)
• Recruiting, screening and enrolling participants
• Coordinating in-person and virtual participant visits and data collection
• Conducting study assessments, including semi-structured and cognitive interviews, neuropsychological testing, physical exams, behavioral interviews, blood draws, survey administration, etc.
• Assisting with systematic and scoping reviews of the literature
• Cleaning and qualitative coding of semi-structured interview transcripts 
• Monitoring and troubleshooting data collection platforms and processing, entering and cleaning study data
• Assisting with preparation of IRB submissions and study reports
• Assisting with the maintenance of regulatory files
• Attending and presenting at community events (e.g., conferences, walks) for the populations we study
• Completing other tasks as assigned, which may include conducting literature searches, updating websites, assisting with grant applications, and preparing study dissemination materials

Supervision Received:

This position reports directly to a Clinical Research Coordinator - Senior.

Required Qualifications*

Associate:

• Bachelor's degree in Health Science or an equivalent combination of related education and experience.
• Completion of NIH's Good Clinical Practice for Social and Behavioral Research eLearning Course OR 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.

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.

All Levels

• Exceptional attention to detail and organizational skills
• Outstanding problem-solving skills and resourcefulness
• Ability to work with diverse teams in a collaborative and effective manner
• Willingness to build and foster relationships with our study participants, community partners and patient stakeholders
• Ability to manage multiple projects and responsibilities simultaneously
• Very comfortable with using, teaching and troubleshooting the technology used in our studies (mobile apps, online survey platforms, etc.)
• Excellent written and verbal communication skills
• Eagerness to learn new skills and take on new responsibilities

Desired Qualifications*

Associate Level

• 4+ years of direct related experience.

Technician Level

• Bachelor's degree in Science, Psychology, Engineering/Data Science, Public Health, or a related field, or an equivalent combination of related education and experience.

All Levels

• An understanding of medical terminology
• Knowledge of university policies and procedures
• Experience conducting and coding qualitative interviews
• Experience using qualitative analysis software
• Experience conducting scoping reviews
• Experience conducting study start-up activities (e.g., creating CRFs and other study documents, etc.)
• Experience programming and using REDCap, Qualtrics and/or LifeData survey platforms
• Experience conducting neuropsychological tests
• Experience performing blood draws
• Experience with MiChart, Oncore and/or eResearch
• PEERRS, CITI or NIH Protection of Human Subjects Training certification
• Background/interest in data analysis, data management and/or programming

Work Schedule

Hybrid work scheduled Monday - Friday, with variability depending on the needs of study participants. Occasional evening and weekend work is required for this position.

Underfill Statement

This position may be underfilled at the Clinical Research Technician title based on the selected candidate's qualifications.

Additional Information

This is a term-limited position with funding available through June 30, 2027, with an extension possible if additional funding is secured. At the end of the stated term, your appointment will terminate, and will not be eligible for Reduction-in-Force (RIF) benefits. This term-limited appointment does not create a contract or guarantee of employment for any period of time as you will remain subject to disciplinary or other performance measures, up to and including termination, at the will of the University in accordance with existing University policy and standards for employee performance and conduct.

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.

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.