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 is a part-time position with 50-75% effort (20 - 30 hours/week).
This position will provide study coordination for clinical research studies. Coordinator experience and mastery of all job duties from the Clinical Research Technician position on the Michigan Medicine CRC Career Ladder is required for the CRC Associate role. 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. Key behavioral competency descriptors include demonstrate, implement, execute, and use.
Independent knowledge, skills, and abilities within 8 competency domains is expected:
- Scientific Concepts and Research Design
- Ethical Participant Safety Considerations
- Investigational Products Development and Regulation
- Clinical Study Operations (GCPs)
- Study and Site Management
- Data Management and Informatics
- Leadership and Professionalism
- 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.
- 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.
- This position reports directly to a Clinical Research Coordinator Intermediate.
- 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.
- Bachelor's degree in Health Science, Psychology, Engineering/Data Science, Public Health, or a related field, 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 and must be achieved by 01/01/24. After 01/01/24, certification is required within six months of date of hire.
- Minimum 2 years of directly related experience in clinical research and/or clinical trials.
- Associate degree in Health Science, Psychology, Engineering/Data Science, Public Health, or a related field, or an equivalent combination of related education and experience.
- ONE of the following:
- Minimum 1 year of directly related experience in clinical research and/or clinical trials.
- Advanced degree in health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social work, Psychology, Epidemiology.
- 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.
- Associate's or Bachelor's degree in Health Science, Psychology, Engineering/Data Science, Public Health, or a related field, or an equivalent combination of related education and experience.
- Background/interest in data analysis, data management and/or programming.
- An understanding of medical terminology.
- Knowledge of university policies and procedures.
- Experience conducting and coding qualitative interviews.
- Experience using qualitative analysis software.
- 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.