University of Michigan · 3 hours ago
Clinical Research Coordinator - Assistant
Ann Arbor, MI
Full-time
Hybrid
Mid Level
3+ years expThe University of Michigan is a leading health care complex known for its groundbreaking advancements in medicine and technology. They are seeking a Clinical Research Coordinator - Assistant who will coordinate multiple clinical research studies, ensuring compliance with protocols and managing study activities with minimal supervision. The role involves performing study procedures, managing data, and assisting with regulatory documentation.
E-LearningEducationHigher EducationUniversities
Responsibilities
Performs non-GCP related study management activities; Performs study procedures with minimal supervision; Schedules, assists with preparation for, and attends study initiation meetings, monitor visits, and audits; Ensures integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.)
Demonstrates understanding of protocol elements/requirements and demonstrate the ability to execute study procedures
Demonstrates the ability to anticipate and mitigate the potential for protocol non-compliance
Describes protocol structure and explains how to interpret study requirements to ensure study compliance
Demonstrates accurate implementation of protocol procedures
Explains and performs study non-GCP related study management activities
Performs study procedures with minimal supervision
Triages simple subject concerns and issues appropriately
Ensures integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.)
Comfortable with basic clinical lab equipment such as a centrifuge, various freezers, pipettes, and standard laboratory safety requirements and guidelines
Explains the role of the Clinical Trial Support Unit (CTSU) for initiating new studies, and for subject visit billing
Demonstrates the ability to document data in accordance with ALCOA-C principles; Completes complex data collection during study visits; Demonstrates ability to resolve data queries
Demonstrates the ability to document data in accordance with ALCOA-C principles
Explains how to utilize information from the EMR and study databases
Completes complex data collection during study visits
Demonstrates ability to resolve data queries
Explains and performs study operational activities in compliance with Good Clinical Practice (GCP)
Explains proper documentation techniques as outlined in the ICH-GCP guidelines
Explains the difference between Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information and Occurrences (ORIOs), can appropriately identify them and report them
Works with the Office of Research Compliance Review to create and post studies in ClinicalTrials.gov and obtain the NCT
Demonstrates understanding of University and Federal guidelines in order to assist with Investigator Initiated studies
Collaborates with MIAP for INDs and IDEs
Demonstrates an understanding of the elements of subject safety, related documentation, and reporting. Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks
Demonstrates proficiency in all eResearch applications and submissions, such as continuing renewals and amendments
Demonstrates ability to maintain essential regulatory documents as outlined in the ICH-GCP guidelines
Maintenance of updated regulatory documentation
Explain the investigational products development process and identify key regulations to control these processes
Provide other administrative support for study activity including management of subject reimbursement and payments
May assist with creating posters, abstracts, and articles
Participates in regular study meetings. Properly completes payment forms and pays participants accordingly
Participates in trainings specifically for certification as a Clinical Research Professional
All training requirements of previous level
PEERRS, HIPAA, CITI GCP
ERPM` Regulatory training
Attends and participates in all training assigned to this level
Qualification
Required
High school diploma or GED is necessary
Experience in a medical setting
Previous experience with subject recruitment and retention, and coordination and management of clinical trials required
Experience in the regulatory aspect of clinical trial management
Ability to work independently or as a member of a team
Demonstration of understanding of Medical Terminology
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
Preferred
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
Benefits
Excellent medical, dental and vision coverage effective on your very first day
2:1 Match on retirement savings
Company
University of Michigan
The mission of the University of Michigan is to serve the people of Michigan and the world through preeminence in creating, communicating, preserving, and applying knowledge, art, and academic values, and in developing leaders and citizens who will challenge the present and enrich the future.
10001+ employees
H1B Sponsorship
University of Michigan has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (662)
2024 (594)
2023 (787)
2022 (473)
2021 (411)
2020 (324)
Funding
Current Stage
Late StageTotal Funding
$359.75MKey Investors
Michigan Economic Development CorporationNational Institutes of HealthBreakthrough T1D
2025-07-17Grant· $1M
2025-06-07Grant· $1.17M
2025-04-23Grant
Leadership Team
Greg McGuire
Managing Director, Mcity
Robert Goodspeed
Chair, Urban and Regional Planning Program
Recent News
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