Gillette Children's · 20 hours ago
Clinical Research Coordinator I - Spine
St Paul, MN
Full-time
Hybrid
New Grad, Entry Level
$28.90/hr - $43.36/hrGillette Children's is a global beacon of care for patients with brain, bone and movement conditions that start in childhood. They are seeking a Clinical Research Coordinator I to support the Spine Research Program, facilitating research coordination and acting as a liaison among various stakeholders.
Non ProfitHealthcareHospitalHealth CareMedicalRehabilitation
Responsibilities
Organizes and facilitates study team meetings
Contributes to protocol development, helps determine protocol feasibility, and coordinates protocol approval processes. Recommends and implements protocol amendments as needed
Coordinates and establishes study schedule, clinical study activity assignments and allocation of staff and equipment
Develops and/or evaluates congruence of data collection tools (e.g. data dictionary, case report forms (CRF), electronic data capture (EDC) with the study protocol
Completes IRB application and amendments, continuing reviews, and other study related documents (consent, assent and HIPAA forms, patient recruitment materials, etc.)
Leads screening and recruitment processes for study subjects
Leads consent and enrollment process when appropriate
Coordinates and manages study per protocol activities and carries out appropriate data collection systems and procedures
Conducts clinical study activity such as phlebotomy and specimen processing, vital signs, ECGs, height and weight, and other tasks as appropriately delegated by PI and record data and results
Serves as liaison to sponsors and outside agencies and collaborators as needed
Provides status updates/reports and manages monitor visits and required activities. Responsible for compiling and reporting protocol activity to study team and providing input and problem solving when needed
Facilitates and conducts close-outs and archiving activities
Works with Investigators on grant application(s) to ensure a smooth and timely submission
Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards
Oversees safety risks (e.g. clinical holds, product recalls) to minimize potential risks to subject safety
Informs the sponsor and IRB of any changes to the protocol or safety concerns and submit progress reports to the IRB per requirements
Ensures adverse event reporting is documented appropriately and maintains follow-up to determine AE resolution
Reviews common laboratory values and alerts
Maintains familiarity with and follows internal/external research guidelines/processes: Federal Drug Administration (FDA) Code of Federal Regulations, FDA guidelines, International Conference of Harmonization Good Clinical Practice (ICH GCP), IRB, National Institution of Health (NIH) and Gillette policies
Maintains strict patient confidentiality according to HIPAA regulations and applicable law
If applicable, works with Investigators on grant application(s) to ensure a smooth and timely submission
Maintains working knowledge of study contract and scope of work
Monitors, reconciles and requests corrections of study related subject visits to ensure that invoicing can accurately take place
Provides consultation to Research Financial Analyst regarding study related expenditures (i.e. study visits, participant reimbursement and time) for invoicing when applicable
Responsible for compiling and reporting protocol activity to study team
Communicates to Research Finance Analyst when study close-out needs to be conducted and consults in this process as needed
Contributes to grant and sponsor budget formation
Participates in completion and execution of contracts as assigned
Qualification
Required
High school diploma/GED
Computer knowledge (use of all Microsoft products such as Access, Excel, PowerPoint, and Word)
Ability to attend out-of-state meetings, as needed
CPR certification (or within 3 months of hire)
Preferred
Knowledge of statistics to interpret and analyze clinical data
Bachelors/Master's degree in science or related medical field
Able to perform height and weight measurements, vital signs
Benefits
Retirement savings match
Tuition and certification reimbursement
Paid time off
Health and wellness benefits for .5 FTE and above
Company
Gillette Children's
Gillette Children's specializes in offering diagnostic, therapeutic, rehabilitation and supports services for children and young adults.
Founded in 1897
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Patrick Nolan
Chief Financial Officer
Thomas Harris, Jr., FACHE
Executive Vice President and Chief Operating Officer
Recent News
Morningstar.com
2025-11-03
Minneapolis / St. Paul Business Journal
2025-02-20
GlobeNewswire News Room
2025-02-04
Company data provided by crunchbase