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Michigan Medicine · 1 day ago

Clinical Research Coord Senior

Ann Arbor, MI

Full-time

Hybrid

Senior Level

5+ years exp

Michigan Medicine is one of the largest health care complexes in the world, and they are seeking a highly organized and proactive Clinical Research Coordinator Senior to support multiple federally-funded research projects. The role involves leading study coordination, ensuring regulatory compliance, and mentoring junior staff while focusing on women's reproductive health research.

EducationHealth CareMedical

Responsibilities

Lead drafting of the protocol, consent, and other required documents based on the instructions and directions provided by the PIs; lead recruitment, enrollment, consent process, and retention strategies for study participants

Ensure scheduling and coordination of study visits/activities, both in clinics and community settings, communicating with clinical teams and external partners

Serve as main liaison among study participants, investigators, sponsors, and operations teams

Develop randomization procedure logistics and ensure adherence; draft study materials: flyers, consent forms, SOPs, and site protocols

Organize and facilitate study meetings (Steering Committees, PI groups); prepare agendas, document minutes, and track next steps

Support outreach and periodic Community Advisory Board/Co-I meetings

Oversee study inventory, ordering supplies, and reconcile purchases

Design, build, and distribute behavioral and clinical surveys; oversee qualitative data collection and coding, including support for NVIVO and REDCap

Ensure robust data management and compliance with study protocols, performing regular quality checks

Oversee scheduling of qualitative interviews and support data analysis

Track enrollment and study progress, reporting on milestones

Independently prepare and manage IRB applications, amendments, continuing reviews, and other regulatory documentation. Support reliance agreements and communications between enrolling sites

Maintain regulatory files, monitor compliance with Good Clinical Practice, ICH guidelines, and university/NIH/PCORI requirements

Address and escalate compliance issues promptly; coordinate responses to sponsor queries or monitor audits

Guide staff in proper use of survey and study instruments

Coordinate and streamline communication among research teams, sponsors, and stakeholders, ensuring tasks and milestones are tracked efficiently, including with outside labs (e.g. LabCorp as needed) to ensure appropriate requisition forms are available and accurate collection and dispatch of samples for resulting

Manage logistical support for boards/committees, prepare presentations and reports

Oversee research billing, financial documentation, and protocol updates

Provide functional supervision and mentorship to clinical subject coordinators, research assistants, and other team members

Train new research staff on study protocols, regulatory processes, recruitment, and data management

Collaborate with programming teams for NIH/PCORI app development, ensuring research integrity

Assist Director of Operations with regular performance evaluations of junior research staff

Lead recruitment and retention strategies at community events, clinics, and through digital platforms

Build and maintain rapport with study participants via phone, in-person, and digital (Zoom, EHR, social media) methods

Adapt outreach approaches utilizing MyChart, DataDirect, social media, and collaborate with external survey research firms for distribution

Coordinate outreach to clinics/organizations and facilitate educational and engagement events to inform community about research findings

Travel regularly across Michigan to support study sites and national meetings as necessary

Support manuscript preparation, compliance reporting, documentation for NIH requirements

Reconcile expenses and coordinate with vendors following university policies

Support pilot grant application management and award processes

Mentor new research staff and students, orienting them to study protocols

Qualification

Clinical Research CoordinationRegulatory ComplianceData ManagementMentorshipGrant ManagementSupervisory ExperienceBilingual SpanishBilingual EnglishCommunicationTeamworkLeadership

Required

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. 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.)

Minimum 5 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA?s Definition of a Clinical Research Professional for qualifying experience prior to applying.)

Preferred

Master's, PhD, or advanced degree in a relevant discipline

Previous experience training and mentoring staff

Prior grant management or Financial documentation experience

Supervisory experience in a research setting

Bilingual fluency in Spanish and English

Benefits

Excellent medical, dental and vision coverage effective on your very first day

2:1 Match on retirement savings

Company

Michigan Medicine

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Michigan Medicine is a health care system and academic medical center that provides medical education and more. It is a sub-organization of University of Maichigan.

Founded in 1869

Ann Arbor, Michigan, USA

10001+ employees