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-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:

Independent 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

Data Responsibilities

• 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 Responsibilities

• 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

Other duties as assigned

• Bachelor's degree or an equivalent combination of related education and experience 
• 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 2 years of directly related experience in clinical research and clinical trials is necessary.

• 4+ years of direct related experience
• At least 1 year of experience working with patients with OUD/SUD 
• Doula certified
• Experience with the OnCore clinical trial management system (CTMS)
• Previous experience with MiChart, RedCap, or Qualtrics
• At least 1 year of experience working with maternal populations or reproductive health
• 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
• Demonstrated ability to work effectively with individuals making a wide range of reproductive health decisions 
• 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 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

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. 

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.

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.

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.

About University of Michigan - Ann Arbor

A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.

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