Michigan Medicine · 1 day ago
Clinical Research Coord Intermediate
Ann Arbor, MI
Full-time
Onsite
Mid, Senior Level
3+ years expMichigan Medicine is seeking a Clinical Research Coordinator to join their obstetrics research team within the Department of Obstetrics and Gynecology. The role involves supporting clinical trials and managing multiple projects aimed at improving maternal and neonatal health outcomes.
EducationHealth CareMedical
Responsibilities
Expert level knowledge, skills, and abilities within all 8 competency domains is expected:
Scientific Concepts and Research Design
Ethical Participant Safety Considerations
Investigational Products Development and Regulation
Clinical Study Operations (GCPs)
Study and Site Management
Data Management and Informatics
Leadership and Professionalism
Communication and Teamwork
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
Coordinate with study teams at other institutions to stay up to date on study protocols and other relevant research tasks for multi-site studies
Acts as a liaison or point of contact between investigators, research teams, sponsors, other universities, cooperative groups, other internal and external departments to get questions answered and issues resolved
Reviews study forms, databases, regulatory files, and all study related work for completion and accuracy
Continually review and evaluate progress of projects and studies in order to identify problems, improve quality and implement solutions or improvements
Assist leadership team on various duties related to research as needed (such as specimen collection protocols, on-call systems, standard operation procedures, etc.)
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
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 3 years of directly related experience in clinical research and clinical trials is necessary
Demonstrate ability to work successfully while meeting competing deadlines
Excellent interpersonal skills
Flexible work schedule
Demonstrated ability to prioritize and exercise good judgement
High attention to detail and accuracy
Primary activities are performed independently, and decisions are made free from immediate direction
Excellent communication skills, with the ability to receive and convey information clearly and concisely for various mediums
Excellent interpersonal and organizational skills, and the ability to work effectively with diverse groups
A high degree of initiative, resourcefulness and organization skills
Demonstrated problem solving, conflict resolution, analytical, and critical thinking skills
Demonstrated ability to work well under time constraints and meet deadlines
Demonstrated coordination, time management and communication skills
Capable of conducting all start-up, active implementation, and closeout activities
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
6+ years of direct related experience
Previous experience in women's health and/or the field of obstetrics
Experience working on multi-site studies
Previous experience with MiChart, RedCap, and Qualtrics
Demonstrates the ability to create and manage databases
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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