University of Michigan · 14 hours ago
Clinical Research Coordinator Intermediate
Ann Arbor, MI
Full-time
Hybrid
Entry, Mid Level
$53K/yr - $65K/yr
2+ years expThe University of Michigan is a world-class institution dedicated to discovery and care, and they are seeking a Clinical Research Coordinator Intermediate to contribute to their mission. This role involves clinical monitoring, regulatory compliance, and supporting study operations within the Statistical Analysis of Biomedical and Educational Research (SABER) unit.
E-LearningEducationHigher EducationUniversities
Responsibilities
Clinical monitoring and site oversight
Conduct on-site and remote monitoring visits to assess compliance with GCP, ICH, protocol requirements, and regulatory standards
Perform source data verification and review CRFs for accuracy, completeness, and timeliness
Prepare detailed monitoring visit reports documenting site, pharmacy, laboratory, and unit performance
Reconcile investigational product/device accountability with clinical sites
Regulatory compliance and safety oversight
Ensure essential regulatory documentation is collected, maintained, and filed in the Trial Master File
Facilitate IRB, Sponsor-Investigator, and site interactions to support regulatory compliance
Screen adverse events for seriousness and coordinate AE/SAE reporting to sponsors and IRBs
Support adherence to local, federal, and institutional research regulations
Study operations and participant management
Monitor participant recruitment, enrollment, and retention; collaborate with teams to enhance recruitment strategies
Assist in maintaining accurate study databases (enrollment, refusals, deviations, withdrawals)
Support timely and complete study documentation to ensure efficient trial operations
Cross-functional collaboration and continuous improvement
Partner with project management, data management, statistics, regulatory, and quality teams to identify issues and implement solutions
Consult across SABER functional areas to support successful study conduct
Participate in internal and external meetings and contribute to departmental policy review
Maintain and develop best practices and standards for efficient monitoring and quality oversight
Qualification
Required
Bachelor's degree with at least 2 years of experience, or an equivalent combination of education and work experience in a research setting
Implementation of GCP, ICH guidelines, and applicable regulatory guidelines in the conduct of clinical research
Experience in reading medical records
Proficient in electronic data capture systems, e.g., OpenClinica, REDCap Cloud
Ability to communicate effectively and follow written and verbal instructions
Demonstrate strong analytical and organizational skills, including high-level accuracy and attention to detail, while exercising good judgment
Proven ability to set priorities, exercise initiative, work simultaneously on numerous projects, and meet/negotiate deadlines
Ability to effectively work independently, as well as with diverse teams
Demonstrate efficient organizational skills and the ability to effectively problem-solve and implement solutions to improve processes
Excellent interpersonal and conflict resolution skills
Preferred
SOCRA or ACRP certification
Work experience in monitoring clinical trials in an academic or industry setting, including monitoring compliance with research regulations
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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