University of Michigan · 15 hours ago
Clinical Research Coord Assoc
Ann Arbor, MI
Full-time
Onsite
Entry, Mid Level
2+ years expThe University of Michigan is seeking a Clinical Research Coordinator to join their obstetrics research team. The role involves supporting clinical trials and managing multiple projects aimed at improving maternal and neonatal health, particularly for individuals with Opioid and other Substance Use Disorders.
E-LearningEducationHigher EducationUniversities
Responsibilities
Independent knowledge, skills, and abilities within all 8 competency domains is expected
Assist multiple investigators and collaborators to monitor patient recruitment and develop plans to enhance recruitment
Coordinate with the interprofessional team at the Partnering for the Future Clinic and community referral organizations
Screen, recruit, approach and consent pregnant women, giving study overview while being sensitive to environment and patients involved
Attain in-depth understanding of study protocol and objectives to assist with successful implementation of all study procedures
Explaining studies thoroughly, reviewing informed consent, answering questions and following GCP/IRB and obtaining consent
Execute study visits and study related procedures
Triage complex study concerns appropriately
Work effectively with individuals making a wide range of reproductive health decisions
Collect of human biospecimens, as well as processing, preparing and shipping specimens to outside institutions according to study protocol requirements
Submit Human Subjects Incentive Program (HSIP) requests
Coordinate with study teams at other institutions to stay up to date on study protocols and other relevant research tasks for multi-site studies
Collaborates with medical staff to facilitate and optimize the care of research patients
Develop and monitor protocols and infrastructure for clinical studies
Track, document and report on study progress
Review real time medical records to match potential research participants with inclusion/exclusion criteria for active studies
Schedule subject visits and follow up interactions by facilitating communication between clinic/unit staff and investigators/study team
Perform study-specific testing and oversee specialized research devices and equipment
Investigate, modify, and integrate new procedures as needed
Serve as primary liaison between study staff, subjects, investigators, other departments, and sponsors
Working with Research Pharmacy in ordering and obtaining study medication
Travelling to various clinical/social services sites within southeast Michigan
Assist in conducting individual interviews and focus groups Various duties as needed
Provide overnight and weekend on-call duties
Various duties as needed
Create case report forms, questionnaires and study related documents
Complete study documentation in various data systems
Responsible for data entry, management, cleaning and database creation for several studies
Triage complex data concerns appropriately
Abstract data from the medical record
Review collected data and perform data quality assurance of the collected data
Create reports on the completeness and quality of the collected data
Assist with quantitative and qualitative analysis
Support the maintenance study registries, including data entry, validation, and streamlining. Oversee student researchers entering data
Support collecting patient reported outcomes
Various duties as needed
Assist PI and study team in maintaining IRB (eResearch) applications including scheduled continuing reviews, adverse event reporting (events that either occurs in UM research subjects or subjects from other centers in multi-site studies) and other reportable information and occurrences
Assist PI with identifying and grading adverse events
Ensure compliance with study protocols, good clinical practice guidelines and FDA regulations
Assist with any regulatory and institutional and external monitoring visits
Other duties as assigned
Qualification
Required
Bachelor's degree or an equivalent combination of related education and experience
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 certification is required within six months of date of hire
Minimum 2 years of directly related experience in clinical research and clinical trials is necessary
Preferred
4+ years of direct related experience
At least 1 year of experience working with patients with OUD/SUD
Doula certified
Experience with the OnCore clinical trial management system (CTMS)
Previous experience with MiChart, RedCap, or Qualtrics
At least 1 year of experience working with maternal populations or reproductive health
Previous experience with chart abstraction and/or data entry
Flexible work schedule
Excellent verbal and written communication skills
Excellent interpersonal and organizational skills, and the ability to work effectively with diverse groups
Demonstrated ability to work well under time constraints and meet deadlines
Demonstrated ability to prioritize and exercise good judgement
Demonstrated ability to work effectively with individuals making a wide range of reproductive health decisions
High attention to detail and accuracy
Demonstrated ability to work independently with minimal supervision as well as work as part of a team
Demonstrated problem solving, conflict resolution, analytical, and critical thinking skills
Demonstrated coordination, time management and communication skills
Demonstrated ability to perform the majority of tasks independently and perform quality checks of their work
Personal transportation to support various work locations
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
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