SIGN IN
Clinical Research Coord Senior/Intermediate jobs in United States
info-icon
This job has closed.
company-logo

Michigan Medicine · 1 day ago

Clinical Research Coord Senior/Intermediate

Michigan Medicine is one of the largest health care complexes in the world, and they are seeking a highly motivated and organized Clinical Research Coordinator Senior/Intermediate to support federally funded projects in the department of obstetrics and gynecology. The successful candidate will coordinate study operations, ensure efficient project execution, and assist with the management of clinical research activities while collaborating closely with principal investigators and research staff.
EducationHealth CareMedical

Responsibilities

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
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
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
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
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

Qualification

Clinical Research CoordinationRegulatory CoordinationResearch Data CoordinationMicrosoft Office SuiteREDCapCertified Clinical Research CoordinatorStudy ManagementData ManagementCommunication SkillsProblem-Solving SkillsCollaboration SkillsAttention to DetailOrganizational Skills

Required

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 (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
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)

Preferred

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
For Intermediate, a degree plus 6+ years of related research or clinical coordination is typical; for Senior, 9+ years of experience is required

Benefits

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

Company

Michigan Medicine

company-logo
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.

Funding

Current Stage
Late Stage

Leadership Team

leader-logo
Heather Ascani
Director, Business Operations - Applied Systems Biology Core
linkedin
leader-logo
Jack Kufahl
Chief Information Security Officer
linkedin
Company data provided by crunchbase