A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
The Program in Research and Innovation on Maternal and Neonatal Outcomes (PRIMO), housed within the Department of Obstetrics and Gynecology seeks a Clinical Research Coordinator to join our fast-growing obstetrics research team. The ideal candidate will assist on a variety of obstetrical health research studies, playing a vital role in supporting clinical trials and overseeing the daily management of multiple projects aimed at advancing the health of women, infants and reproductive choices. This position requires a flexible schedule, with some evening and weekend coverage, and ability to work at various Michigan Medicine locations.
This position will primarily support research for the Partnering for the Future (PFF) Program, a clinical and research program that serves birthing people with Opioid and other Substance Use Disorders (OUD/SUD) as well as chronic pain. The ideal candidate will have a background in maternal health.
CRC STATEMENT:
This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the CRC-Intermediate position on the Michigan Medicine CRC Career Ladder is required. This position should begin to serve on various clinical research committees at the University level. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work. This level of CRC continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: Design, demonstrate, develop, guide, and support.
Characteristic Duties and 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
Additional duties will include:
Study Interactions and Clinical Coordinator Responsibilities
- 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
Administrative Responsibilities
- 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 dut
