Michigan Medicine · 15 hours ago
Clinical Research Coordinator - Associate
Ann Arbor, MI
Full-time
Onsite
Entry, Mid Level
2+ years expMichigan Medicine is dedicated to improving health outcomes through education, patient care, community service, research, and technology development. They are seeking a Clinical Research Coordinator to provide clinical trial study support and manage multiple research projects focused on maternal and infant health. The role involves overseeing study interactions, coordinating research efforts, and ensuring compliance with study protocols and regulations.
EducationHealth CareMedical
Responsibilities
Oversee and assist multiple investigators and collaborators
Work effectively with individuals making a wide range of reproductive health decisions
Coordinate research efforts with multiple principal investigators, the Cardio-Obstetrics clinic, and research subjects
Screen, recruit, approach and consent pregnant and postpartum individuals with cardiovascular conditions or elevated cardiovascular risk, giving study overview while being sensitive to environment and patients involved
Attain in-depth understanding of cardio-obstetric 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
Collect of human biospecimens, as well as processing, preparing and shipping specimens to outside institutions according to study protocol requirements
Run protocolized, supervised experiments or assays in a laboratory setting
Submit Human Subjects Incentive Program (HSIP) requests
Collaborate 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
Travel to various Michigan Medicine sites
Provide overnight and weekend on-call duties
Ability to be at work location in less than 45 mins
Various duties as needed
Assist in the development of data collection instruments and study specific databases
Chart abstraction and data entry into various databases
Triage complex data concerns appropriately
Routinely monitors integrity, quality, and security of data collection for multiple research databases
Resolve data quality queries
Assist in analysis
Various duties as needed
Assist PI and study team in submitting and maintaining IRB (eResearch) applications including scheduled continuing reviews and 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
Ensure compliance with study protocols, good clinical practice guidelines and FDA regulations
Assist with any documentation preparation, organization and any regulatory need for institutional and external monitoring visits
Responsible for maintaining laboratory standards and expectations as well as associated mandatory certifications
Working with Research Pharmacy, study medication and chain of custody
Other duties as assigned
Qualification
Required
Bachelor's degree 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 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
Demonstrate ability to work successfully while meeting competing deadlines
Flexible work schedule
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
Previous experience with chart abstraction and/or data entry
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 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
Preferred
4+ years of direct related experience
Experience working with on cardiovascular or maternal health studies
Previous experience with MIChart/Epic, REDCap, and Qualtrics
Demonstrates the ability to create and manage databases
Familiarity with basic science techniques and specimen processing
Exposure to, experience in, and/ or enthusiasm for cardiovascular medicine as it pertains to obstetric populations
Dedication to the betterment of women's health through the conduct of rigorous science
Company
Michigan Medicine
Michigan Medicine is a health care system and academic medical center that provides medical education and more. It is a sub-organization of University of Maichigan.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Heather Ascani
Director, Business Operations - Applied Systems Biology Core
Jack Kufahl
Chief Information Security Officer
Recent News
2025-12-11
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