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Your role with the company:
Clinical Documentation & Site Support
· Manage clinical site documentation, including IRB approvals, informed consent materials, agreements, and regulatory files.
· Track and maintain current CVs and credentials for study site personnel.
· Serve as a point of contact for clinical sites on documentation and follow-up visit schedules.
· Maintain accurate, audit-ready study files in electronic systems.
Image & Data Management
· Coordinate receipt, processing, and tracking of clinical images and related data from study sites and core labs.
· Resolve issues with sites and vendors to ensure timely and complete data submissions.
· Maintain image data records in EDC and ensure quality and compliance.
Payments & Financial Tracking
· Process site payments, vendor invoices, and compensation for data management groups, core labs, and study committees.
· Develop and maintain payment tracking databases to ensure accuracy and provide accrual information to Finance.
· Communicate with sites and vendors to ensure timely and accurate payment processing.
Device & Logistics Coordination
· Support operations with study device shipments, returns, and documentation.
· Maintain accurate records of device disposition and returns.
· Coordinate with Operations on purchase orders and shipping logistics.
Meeting & Training Support
· Assist in coordinating investigator, study coordinator, and committee meetings (on-site and remote).
· Assist with travel and logistics when supporting meetings.
· Prepare training materials, track attendance, and monitor meeting costs.
General Team Support
· Order, assemble, and maintain supplies of study binders, materials, and equipment.
· Provide cross-coverage to support other coordinators as workloads shift.
· Contribute to process improvements and team initiatives as needed.
Desired Profile:
· Associate or Bachelor’s degree required; degree in life sciences or healthcare field preferred.
· 3–5 years of experience in clinical research, clinical trials, or FDA-regulated healthcare environment.
· Strong knowledge of clinical documentation requirements and trial operations.
· Skilled in Microsoft Office (Excel, Word, PowerPoint, Outlook); proficiency with EDC or clinical databases strongly preferred.
· Excellent organizational skills with the ability to manage multiple priorities in a fast-paced environment.
· Strong attention to detail, accuracy, and follow-through.
· Clear communicator who builds positive working relationships with internal teams, sites, and vendors.
· Demonstrated commitment to a coordinator-level role as a valued and stable contributor.
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