This is the entry level position on the Michigan Medicine CRC Career Ladder. This position provides administrative and coordination support for multiple projects in the conduct of clinical research projects. This position may assist with study coordination but will not be assigned clinical trials independently. This position may provide coordination for clinical research projects such as registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies.
Characteristic Duties and Responsibilities:
Knowledge of all 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
Understands protocol structure and how to interpret study requirements to ensure study compliance.
Demonstrates ability to screen participants for study eligibility & enroll with accuracy in various databases.
Demonstrates the ability to complete simple data collection during study visits
Enters data to complete forms (CRFs) on paper, databases, or Electronic Data capture (EDC).
May administer minimal risk consents, surveys, and questionnaires.
Performs simple study procedures with accuracy.
Performs clerical duties, including, but not limited to, mailing and filing correspondence, calling patients and obtaining medical records.
May assist research coordinator in conduct of Site Initiation Visit (SIV); attends SIV
May assist in and attends monitor visits and or audits.
Ability to assist with regulatory aspect of clinical trial management.
Prepare study procedure kits, shippers, CRFs, and requisition forms.
Ability to work independently or as a member of a team
Exceptional organizational and computer skills in Microsoft software applications.
Ability to work with minimal supervision while maintaining productivity standards
Demonstrated problem solving and conflict resolution skills.
Ability to multi-task, work well under time constraints and meet deadlines.
Excellent interpersonal, collaborative, oral and written communication skills with exceptional attention to detail and exercise of good judgement.
Perform other related duties as assigned.
Understands importance of participant confidentiality and complies with HIPAA and U of M regulations
Demonstrates professional behavior and ethical integrity through the applications of all established processes and procedures related to the ethical treatment of participants
Is familiar with basic clinical lab equipment such as a centrifuge, freezers (various), pipettes, and standard
Laboratory safety requirements and guidelines.
Other duties as assigned
- High school diploma or GED is necessary.
- Associate Degree in Health Science or an equivalent combination of related education and experience is desirable.
- An understanding of medical terminology
- Experience in a large complex health care setting
- Ability to effectively communicate with staff and faculty of all levels
- Knowledge of university policies and procedures is desirable.
- Previous experience with spirometry testing and/or sputum induction desired, however on-site training is available.
- Clinical experience with respiratory patients is highly desired.
- Certification through ACRP or SOCRA.
- 3+ Years of Clinical Research Experience.
M-F from 7:30 AM - 4:30 PM with some variability in start and end times depending on the needs of the clinical trial participants. Hybrid
Supervision Received:
This position receives direct supervision and reports directly to CRC-Project Manager.
Supervision Exercised:
None
This is a term-limited appointment. 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 conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may
