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 Department of Obstetrics and Gynecology, is looking for an experienced Clinical Research Coordinator to join our fast-growing obstetrics research team. This person will be key in providing clinical trial study support and day to day management of multiple research projects focused on improving women and infant health. The ideal candidate would have background and experience in the area of obstetric or women?s health research.
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.
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
Oversee and assist with screening, recruitment, and consenting participants
Assist multiple investigators and collaborators to monitor patient recruitment and develop plans to enhance recruitment
Explaining studies thoroughly, reviewing informed consent, answering questions and following GCP/IRB and obtaining consent
Execute study visits and study related procedures
Perform study-specific testing on study subjects
Triage complex study concerns appropriately
Specimen handling, process lab samples, manage laboratory samples and shipping
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
Investigate, modify, and integrate new procedures as needed
Serve as primary liaison between study staff, subjects, investigators, other departments, and sponsors.
Trains and supports study team members
Various duties as needed
Assist in the development of data collection instruments and study specific databases
Chart abstraction and data entry into databases
Triage complex data concerns appropriately
Routinely monitors integrity, quality, and security of data collection for multiple research databases.
Resolve data quality queries.
Various duties as needed
Assist MFM Project Manager 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.
Working with Research Pharmacy, study medication and chain of custody
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 MFM Research Project Manager on various duties related to MFM research as needed
This position reports directly to the MFM Research Project Manager
Possibly provide Functional supervision, in a limited capacity, such as training of staff in titles within the CRC Career Ladder.
Bachelor's degree in Health Science 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 equivalent and must be achieved by 01/01/24. After 01/01/24, 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
Demonstrated ability to prioritize and exercise good judgement
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 and resourcefulness
Demonstrated problem solving, conflict resolution, analytical, and critical thinking skills
Demonstrates the ability to create and manage databases.
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.
6+ years of direct related experience
Previous experience in the field of obstetrics
Experience working on multi-site studies
Previous experience with MiChart, RedCap, and Qualtrics
M-F; hours vary depending on the study needs; general hours are within the 7am-5pm range with occasional evening hours
Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
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