University of Michigan · 15 hours ago
Clinical Research Coord Inter TERM-LIMITED
The University of Michigan is seeking a motivated individual to serve as a Clinical Research Coordinator (CRC) for clinical research studies. The role involves managing and coordinating all aspects of assigned clinical research projects, ensuring compliance with regulations, and contributing to the development of new processes and tools for research activities.
E-LearningEducationHigher EducationUniversities
Responsibilities
Manages and coordinates all aspects of assigned clinical research portfolio including but not limited to:
Regulatory submissions, creation/maintenance of regulatory binders
Subject screening, consenting, enrollment, management of study records
Data collection, entry, sharing, storage, management, query resolution
Create and complete case report forms, source documentation, study documents and tools
Database/survey development in various electronic platforms (REDCap, Qualtrics)
Effectively communicate with sponsors; coordinate, prepare, and attend visits for site initiation, monitoring, auditing, and/or closeout
Assess studies for execution and troubleshoot potential implementation issues
Provide cross-coverage on projects
Performs study procedures with accuracy
Demonstrates ability to triage complex study concerns appropriately
Demonstrates ability to manage increasing levels of protocol complexity and/or volume efficiently
Contributes to the development of processes and tools to capture data in accordance with ALCOA-C principles
Resolves complicated queries
Demonstrates an understanding of Investigational products development process and applies key regulatory requirements to control these processes
Monitors site compliance with subject safety reporting, escalates issues, and contributes to the development of tools and processes to enhance subject safety during the conduct of a clinical study
Provides logistic and regulation guidance on Investigator Initiated Studies for adherence to University and Federal guidelines
Provide other administrative support for study activity including management of subject reimbursement and payments
Participates in trainings specifically for maintaining certification as a Clinical Research Professional
Qualification
Required
Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary
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. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire. (Please review eligibility criteria from SoCRA or ACRP prior to applying.)
Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA's Definition of a Clinical Research Professional for qualifying experience prior to applying.)
Excellent organizational skills and attention to detail
Superb interpersonal skills - comfortable speaking with healthcare providers, research sponsors, and patients
Ability to communicate effectively and professionally in both verbal and written form
Ability to work independently but also within a team
Ability to prioritize multiple tasks and meet deadlines are a must
Preferred
6+ years of direct related experience
Excellent communication skills
Ability to foresee needs of investigators/study teams and respond accordingly
Possess critical thinking skills
Ability to triage complex study concerns appropriately
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.
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
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