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.  

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:

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 

• 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

Data Responsibilities

• 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

Regulatory Responsibilities

• 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

Administrative Responsibilities

• 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

Supervision Received:

This position reports directly to the MFM Research Project Manager

Supervision Exercised:

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.

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 opportunity/affirmative action 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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