How to Apply

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.

Summary

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-Intermediate position on the Michigan Medicine CRC Career Ladder is required, including experience with various committees at the University. This position gives back to the institution through mentoring others on study management and participating in training and development of junior clinical research professionals.  This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and mentor study team members in the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This level of CRC develops new processes, procedures, tools, and training to enhance clinical research activities across the competency domains. This position 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, develop, evaluate, guide, mentor, and support.

Mission Statement

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.

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world’s most distinguished academic health systems.  In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

Responsibilities*

Characteristic Duties and Responsibilities:

Contribute to the development of process and tools in 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

• 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 Regulatory specialist in preparing and maintaining, IRB (eResearch) applications including new applications, scheduled continuing reviews, amendments, 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.
• Facilitates monitoring or DSMB meetings
• Schedules, prepares for, and attends study initiation meetings, monitor visits, and audits
• Working with Research Pharmacy, study medication and chain of custody
• Contributes to the development of processes and tools to ensure regulatory compliance for all studies related to the Labor and Delivery Tissue Committee
• Assist Research Compliance Specialist to ensure all studies in MFM compliant with federal and institutional guidelines

• 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
• Supports and runs weekly and monthly research meetings
• Reviews study forms, databases, regulatory files, and all study related work for completion and accuracy
• Develops standard operating procedures, work-aids and other guidance
• Continually review and evaluate progress of projects and studies in order to identify problems, improve quality and implement solutions or improvements
• Collaborate with PIs, and liaison to Clinical Trial Service Units, on strategic project resource planning including assisting with staff and study need
• Work within CTSU framework for initiating and oversight of multiple studies with billing calendars  
• Assist with writing timely reports for funding agencies
• Assist Research Operations Manager on various duties related to MFM research as neededaA

Required Qualifications*

• 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) and must be achieved by 01/01/24.
• 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.

Level Specific Requirements:

• CRC Governance Committee review and approval   

• Minimum 5 years of directly related experience in clinical research and clinical trials is necessary.

INTERMEDIATE:

• Minimum 3 years of directly related experience in clinical research and clinical trials is necessary.  

Desired Qualifications*

• SENIOR: 9+ years of direct related experience
• INTERMEDIATE: 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

Work Schedule

M-F; hours vary depending on the study needs; general hours are within the 7am-5pm range with occasional evening hours.

Work Locations

• Coordinator work is currently being conducted in a hybrid model with a mixture of remote and on-site work as needed to perform the requirements of the role while maintaining high quality and service level to principal investigators and patients
• Primary location is at the main medical campus in University Hospital South (UH South); with regular work activities at VonVoightlander Women’s Hospital, West Ann Arbor and other Michigan Medicine locations within Ann Arbor.

Underfill Statement

This position may be underfilled at the CRC-Intermediate title based on selected candidates’ qualifications and the review and approval of the Michigan Medicine CRC Governance Board.

Additional Information

The use of this title requires approval by the University of Michigan Clinical Research Coordinator Governance Board to ensure equity in title placement across Michigan Medicine.

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. 

Background Screening

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.

Application Deadline

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.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.

U-M COVID-19 Vaccination Policy

COVID-19 vaccinations, including one booster when eligible, are required for all University of Michigan students, faculty and staff across all campuses, including Michigan Medicine.  This includes those working remotely and temporary workers.   More information on this new policy is available on the U-M Health Response website or the UM-Dearborn and UM-Flint websites.