"Clinical Research Technician/Assistant"

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-Assistant position on the Michigan Medicine CRC Career Ladder is required.

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

We are seeking a motivated clinical research professional who enjoys patient-oriented, collaborative translational science and desires to contribute to research in a team-based environment. The Clinical Research Coordinator will join the clinical research team within the growing Pediatric Diabetes Research Program at the University of Michigan. The clinical Research Coordinator will assist with recruiting, screening, consenting and enrolling research participants in our Pediatric Endocrinology clinics. The position will also involve in the development of a prospective Type-1 juvenile diabetic patient cohort, coordinating follow-up visits for patients in our longitudinal cohorts, clinical data entry, database management, and training in collection of patient bio specimens and disease activity measures. The principal ongoing project that the Clinical Research Coordinator will work on involves building patient disease registries as part of the industrial research projects led by the PI.

The Clinical Research Coordinator will play a central role in the delivery of high-quality results in the following key responsibilities:
Prepare, manage, and organize space for study related materials and equipment to accomplish the following:

• Identify, screen and enroll potential subjects; consent minimal risk subjects
• Perform data management, such as entering information into Case Report Forms (CRFs)
• Assist with collection of external medical records for study reporting purposes
• Work collaboratively with the CTSU team by maintaining a good rapport and communication with research teams and faculty, as well as patients and families
• Coordination of multicenter study and patient engagement efforts

Collect and manage patient and laboratory data for clinical research subjects.

Collection of patient bio specimens and disease activity measures; maintain oversight to ensure integrity of specimens (collection, shipping/packing, storing, labeling, tracking, etc).

Assist with developing and writing Abstracts/Manuscripts and/or Clinical Trials Protocols.

Support the preparation for IRB audit and monitor:

• Assist in the preparation of IRB applications, amendments and scheduled continuing reviews, progress reports, safety reports and adverse event reports
• In coordination with other CTSU staff, communicate with sponsors concerning progress of clinical research, 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
• Assist in the training of other research staff in the research program

Supervision Received:

This position receives direct supervision and reports directly to (a CRC-Lead, CRC-Project Manager, a unit Administrator, Director, or Faculty Principal Investigator). Functional supervision may be received from the Clinical Research Coordinator Senior in the team.

Supervision Exercised:

None.

Required Qualifications:

• Excellent interpersonal, oral, and written communication skills
• Proficient computer skills including Microsoft software applications
• Ability to organize/prioritize tasks effectively and efficiently
• Demonstrated ability to manage work across a set of diverse stakeholders (e.g., study subjects, research assistants, research investigators, regulatory staff/agencies)
• Ability to set goals, exercise sound professional judgment, and problem-solve within delegated authority
• Ability to work independently to meet milestones and deadlines
• Solid attendance record and work ethics

Technician Level:

• 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;
  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

Assistant Level:

• High school diploma or GED is necessary.
• Bachelor's degree in Health Science or an equivalent combination of related education and experience is desirable, as are the following qualifications:

• 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
• Experience and understanding of clinical research or clinical trials
• Experience with the University of Michigan eResearch system
• Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) certification
• Experience of participating in the writing manuscripts and progress reports
• Demonstrated good judgment and strong problem-solving skills related to clinical research experience
• Good understanding of medical terminology
• Familiarity with REDCap, OnCore, Epic, MiChart, and eResearch applications
• Some knowledge of UMHS policies and practice
• Proven experience in administering IRB/regulatory requirements and protocols

The position is full-time. The work schedule will typically be Monday-Friday, 8-hour shifts. However, flexibility on weekends and evenings may be required depending on study needs.

This position may be underfilled at the CRC-Assistant title based on selected candidates’ qualifications.