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.

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.

We are seeking a highly motivated and organized Clinical Research Coordinator ? Intermediate to support federally funded research projects in the Department of Obstetrics and Gynecology. The studies are a collaboration among multiple institutions; aims include eliminating disparities in the fibroid experience through academic and community partnership, an in-vitro fertilization study to understand the best timing of embryo transfer, and other reproductive endocrinology and related areas of research. This role will also support qualitative research coordination?including scheduling interviews and coordinating with researchers?across additional onWHARD-affiliated projects, including fellowship-related research and other investigator-led studies of interest.

The successful candidate will coordinate study operations, move study activities forward incrementally, ensure efficient execution of established protocols and workflows, and assist with the management of clinical research activities. Working closely with principal investigators, community members, and research staff?including the communications director, community engagement manager, and Senior CRCs?this role will coordinate multiple studies under the direction of the Director of Research Operations and study MPIs, and may assist in orienting new staff to established procedures as needed. The ideal applicant is proactive, reliable in following established processes, and excels at independent work, communication, and collaboration. Strong attention to detail and follow-through in executing established study processes, with the ability to flag issues and escalate appropriately, is essential.

We value diverse perspectives and are committed to fostering a collaborative environment where every team member can thrive and contribute to our collective success.

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.

Responsibilities

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

Clinical Research Coordination

• Collaborate closely with the PIs, Director of Operations & Director of Communications, program manager, and study team in planning and executing study activities.
• Organize and facilitate recurring nonfederal or federally funded study meetings (e.g., MPI, Steering Committee, Project PI). Ensure agendas are ready and minutes and next steps are distributed and documented.
• Closely collaborate with the onWHARD team and supervisors on logistics for the annual national study meetings and/or Open House events.
• Under close supervision from manager, serve as a key administrative contact for daily study operations, study tabling events, recruitment plans, and maintaining communication with team members, collaborators, and internal and external stakeholders.
• Participate in study start-up, active, and closeout phases; maintain inventory and coordinate related tasks as directed.
• Support study recruitment in the community and/or clinics as appropriate.
• Coordinate with researchers on additional onWHARD-affiliated projects, including fellowship-related research and other investigator-led studies, such as scheduling interviews and supporting related study logistics.

Research Data Coordination

• Support creation and upkeep of study databases. Develop survey instruments and CRFs in REDCap and/or support staff working on REDCap. 
• Complete case report forms (CRFs), track, identify and report AEs/SAEs in a timely manner, and in coordination with the rest of the study team, support with blood draw supply needs and making kits for distribution.
• Ensure accurate data entry and documentation through established processes and quality checks.
• Support scheduling of qualitative interviews and coordination with researchers, survey development, REDCap build, and assist with qualitative analysis using NVIVO, including for fellowship-related and other investigator-led research projects supported by onWHARD.
• Help train and support staff on data management; assist in resolving data discrepancies.

Regulatory Coordination

• With support from senior coordinator and/or manager, prepare and submit IRB applications, amendments, and continuing reviews.
• Draft consents; help develop and update protocols, SOPs, and study documents.
• Maintain regulatory documentation in compliance with guidelines, collaborating with study leadership.
• Monitor adherence to study protocols; identify and escalate issues in a timely manner.
• Stay current on regulatory requirements and participate in quality assurance activities.

Research Administration/Community & Stakeholder Engagement

• Under supervision/direction, coordinate communication among research teams, sponsors, and stakeholders.
• In close coordination with other CRCs and research assistants, proactively and independently manage project tasks in a timely fashion such as document filing, meeting scheduling, milestone tracking, and database management.
• Draft slides and minutes for meetings and send to team for review; track follow-up items. Support logistical needs for boards/committees, preparing presentations and reports as needed.
• Assist with financial and personnel documentation; monitor staff time and expenses under supervision.
• Support aspects app development, coordinating with the programming team.
• Perform additional administrative tasks as needed for the grants in close coordination with the program/admin coordinator.

Other Duties

• Reconcile expenses following University policies, ensuring reimbursement and payment for all applicable parties are completed in a timely manner. Coordinate with external vendors (e.g., PO, Contracts, MarketSite, QTO orders).
• Under supervision, assist with Pilot Grant processes, including application management and accurate and timely award communications.
• Collaborate with Communications and Community Engagement teams to maintain a database of project materials.
• Support documentation, manuscript preparation, and compliance with NIH requirements.
• Help orient and support new research staff and students; other study-related tasks as assigned.

• Education: Bachelor's degree in Public Health, Social Work, Psychology, Research Administration, Business, Education, Social Sciences, or a related field, or equivalent combination of education and experience.
• Experience: Minimum of 3 years of directly related experience (2 years for Assoc) in clinical or public health research coordination, including study management and regulatory compliance in an academic or health care setting.
• Research & Regulatory: Experience supporting study start-up, initiating IRB applications from scratch and related submissions, study management, and closeout phases, including familiarity with general IRB processes, eResearch, and regulatory documentation.
• Technical Skills: Proficiency in Microsoft Office Suite (Word, PowerPoint, Excel) and experience with research database and data management software such as REDCap (building a database, managing and troubleshooting); familiarity with file-sharing, reference management, and communication platforms including Dropbox, Google Drive, Zotero, EndNote, etc.
• Communication & Organization: Ability to communicate actively; demonstrated attention to detail, follow-through on issues, and strong written and verbal communication skills. Able to independently prioritize tasks, organize work efficiently, and ensure high-quality outputs.
• Collaboration & Diversity: Demonstrated ability to work collaboratively with a wide variety of stakeholders from all walks of life and various organizations, including faculty, staff, participants, and community representatives in multidisciplinary and multicultural environments.
• Initiative & Independence: Demonstrated resourcefulness, problem-solving skills, and ability to work independently and collaboratively within established research protocols and supervisory direction.
• Travel: Willingness to travel throughout Michigan and occasionally nationally as required by project activities.
• Experience using social media, reference management (e.g., EndNote, Zotero), project management (Trello), and virtual collaboration/presentation tools (Google Drive, Zoom, Teams, Slack, Canva).
• Community Engagement: Experience with community engagement or community-engaged research is desired. onWHARD staff rotate responsibility for tabling and community engagement events and are expected to travel locally, sometimes during evenings or weekends, and being a part of these activities and supporting organization and execution is an expected and essential function of this role.

• Master?s degree or progress toward a relevant graduate degree in a field such as Public Health, Social Work, Psychology, or a related discipline.
• Experience with University of Michigan systems, policies, and submission to IRBMed or IRB-HSBS.
• Demonstrated ability to manage multiple projects, set priorities, and meet deadlines accurately and efficiently; able to remain focused while multitasking.
• Experience orienting new research staff and demonstrated interpersonal skills to facilitate team cohesion and collaboration.
• Beginning involvement in clinical research committees at the University level, consistent with growth toward the CRC Senior title.

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.

University Hospital South (UHS) Building, Ann Arbor, MI

Note: this position is hybrid, with at least 2?3 days/wk onsite work regularly in Ann Arbor, MI required and/or additional community-based work days throughout Michigan. There will be some travel to national meetings.

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 any time after the minimum posting period has ended.

The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.