Clinical Research Coordinator Senior/Intermediate

About This Role

Coordinate and streamline operations for federally funded clinical research projects in obstetrics and gynecology, ensuring efficient execution and compliance with regulatory guidelines. This role involves managing multiple studies, assisting with clinical research activities, and potentially supervising junior team members.

Responsibilities

• Contribute to the development of process and tools within 8 competency domains
• Collaborate closely with 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
• Serve as a key administrative contact for daily study operations, recruitment plans, and maintaining communication with stakeholders
• Participate in study start-up, active, and closeout phases; maintain inventory and coordinate related tasks
• Lead study recruitment in the community and/or clinics
• Support creation and upkeep of study databases, develop survey instruments and CRFs in REDCap
• Ensure accurate data entry and documentation through established processes and quality checks
• Oversee scheduling of qualitative interviews and assist with qualitative analysis using NVIVO
• Prepare and submit IRB applications, amendments, and continuing reviews
• Maintain regulatory documentation in compliance with guidelines, collaborating with study leadership
• Coordinate communication among research teams, sponsors, and stakeholders
• Proactively and independently manage project tasks such as document filing, meeting scheduling, and milestone tracking
• Assist with financial and personnel documentation, monitor staff time and expenses
• Help develop and update protocols, SOPs, and study documents
• Manage aspects of federally funded NIH/PCORI app development

Requirements

• Minimum of 3 years directly related experience in clinical or public health research coordination
• Experience in study management and regulatory compliance in an academic or health care setting
• Certification as CCRC or CCRP (or equivalent) within six months of hire
• Experience supporting study start-up, IRB applications, study management, and closeout phases
• Familiarity with general IRB processes, eResearch, and regulatory documentation
• Proficiency in Microsoft Office Suite (Word, PowerPoint, Excel)
• Experience with research database and data management software such as REDCap
• Familiarity with file-sharing, reference management, and communication platforms

Qualifications

• 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
• Minimum of 3 years (Intermediate) to 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

Nice to Have

• Master's degree or PhD in a relevant field
• Experience with University of Michigan systems, policies, and submission to IRBMed or IRB-HSBS
• Experience using social media, project management tools (Trello), and virtual collaboration/presentation tools
• Demonstrated ability to manage multiple projects, set priorities, and meet deadlines
• Experience mentoring or orienting new research staff
• 6+ years of related research or clinical coordination for Intermediate level (degree plus)
• 9+ years of experience for Senior level

Skills

* Required skills

Benefits

Certifications