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.

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally.  Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Characteristic Duties and Responsibilities:

Expert level knowledge, skills, and abilities within all 8 competency domains is expected:

1.  Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. 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 duties related to research as needed (such as specimen collection protocols, on-call systems, standard operation procedures, etc.)

Data Related

• 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

Regulatory & Study reporting

• 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

• 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

• 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.

Hours vary depending on the study needs; general hours are usually Monday-Friday within the 7am-5pm range. On call duties require evening and weekend hours with on-call assignments approximately monthly. 

• Coordinator work is currently being conducted on-site
• Primary location is at the main medical campus in University Hospital South (UH South); with regular work activities at UH South and VonVoigtlander Women?s Hospital/Clinic. 
• This position may include some travel to Michigan Medicine sites as well as other clinical and social services sites across southeast Michigan.

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.

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.

Job openings are posted for a minimum of seven calendar days.  The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

The University of Michigan is an equal employment opportunity employer.