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 Division of Urogynecology and Pelvic Floor Research Group (PFRG) housed within the Department of Obstetrics and Gynecology seeks a Clinical Research Coordinator to assist on several different pelvic floor research projects. The ideal candidate will assist with several pelvic floor and urogynecology research studies and have previous experience or background in women?s health. This person will be key in providing clinical trial study support and day to day management of multiple research projects including approaching women for recruitment, enrollment, specimen and data collection, communication with patients regarding study purpose, study activities, and research appointments; creating documents for accurate tracking and support faculty and fellows in Urogynecology.
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-Associate 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.
Responsibilities
Characteristic Duties and Responsibilities:
Independent 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
- 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
- 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 Michigan medicine site
- Assist in conducting individual and group interviews
Various duties as needed
Data Related
Regulatory & Study reporting
Other duties as assigned
- Assist with events and planning of research related events such as pelvic floor research group day conference.
- Various duties as needed
An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.
- 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
- 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 manageme
