Clinical Research Coord Senior

Clinical Research Coordinator Senior

We are seeking a highly motivated and organized Clinical Research Coordinator Senior to support the federally funded projects grant in the department of obstetrics and gynecology. The studies are a collaboration among multiple institutions: Some of the aims of these studies include: eliminating disparities in the fibroid experience through academic and community partnership, invitro fertilization study to understand the best timing of embryo transfer, and other reproductive endocrinology and related areas of research.

The successful candidate will coordinate and streamline study operations, move the study operations forward incrementally, ensure efficient project execution, 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 Sr. CRCs. This role will coordinate multiple studies and may provide functional supervision for 1-2 junior team members. The ideal applicant is proactive, an effective problem-solver, and excels at independent work, communication, and collaboration. Experience and foresight in anticipating project needs and recommending solutions 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.

Responsibilities*

Contribute to the development of process and tools 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 federally funded NIH & /OR PCORI study meetings (e.g., MPI, Steering Committee, Project PI). Ensure agendas are ready and minutes and next steps are distributed and documented.
• Collaborate with the onWHARD team and supervisors on logistics for the annual national study meetings and/or Open House events.
• Serve as a key administrative contact for daily study operations, tabling events, recruitment plans, maintaining communication with team members and collaborators, internal and external stakeholders, etc.
• Participate in study start-up, active, and closeout phases; maintain inventory and coordinate related tasks as directed.
• Lead study recruitment in the community and/or clinics as appropriate.

Research Data Coordination

• Support creation and upkeep of study databases. Develop survey instruments and CRFs in REDCap and/or support staff working on REDCap.
• Ensure accurate data entry and documentation through established processes and quality checks.
• Oversee scheduling of qualitative interviews, support survey development, REDCap build, and assist with qualitative analysis using NVIVO.
• Train and support staff on data management; help resolve data discrepancies.

Regulatory Coordination

• Prepare and submit IRB applications, amendments, and continuing reviews.
• Maintain regulatory documentation in compliance with guidelines, collaborating with study leadership.
• Monitor adherence to study protocols; escalate issues as needed.
• Stay current on regulatory requirements and participate in quality assurance activities.

Research Administration

• Coordinate communication among research teams, sponsors, and stakeholders.
• 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.
• Help develop and update protocols, SOPs, and study documents.
• Manage aspects of federally funded NIH/PCORI app development, coordinating with the programming team.
• Perform additional administrative tasks as needed for the NIH/PCORI grants.

Other Duties

• Reconciling 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 mentor new research staff and students; and other study related tasks as assigned.

Required Qualifications*

• 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 : 5 years (Senior) directly related experience in clinical or public health research coordination, including study management and regulatory compliance in an academic or health care setting.
• Certification: 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. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire. (Please review eligibility criteria from SoCRA or ACRP prior to applying.
• Research & Regulatory : Must have experience supporting study start-up, starting 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, communication platforms including Dropbox, google drive, Zotero, end note, etc.
• Communication & Organization : Demonstrated work showing attention to detail, follow through on issues, 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.

• Misc : CRC Governance Committee review and approval (Senior)

Desired Qualifications*

• Master's degree or PhD in a relevant field such as Public Health, Social Work, Psychology, or related discipline.
• Experience with University of Michigan systems, policies, and submission to IRBMed or IRB-HSBS.
• Experience using social media, reference management (e.g., EndNote, Zotero), project management (Trello), and virtual collaboration/presentation tools (Google Drive, Zoom, Teams, Slack, Canva).
• Demonstrated ability to manage multiple projects, set priorities, and meet deadlines accurately and efficiently; able to remain focused while multitasking.
• Experience mentoring or orienting new research staff, and demonstrated interpersonal skills to facilitate team cohesion and collaboration.
• 9+ years of experience is required.

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 worlds 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