Clinical Trial Coordinator

This role is responsible for supporting the collection, shipment, tracking, and reconciliation of clinical and translational research samples while ensuring accurate study documentation and communication across internal teams, clinical sites, laboratories, and vendors. The CTC will work closely with Clinical Operations, Clinical Science, Supply Chain & Logistics, Data Management, and external service providers to support study execution and maintain operational coordination of clinical and translational activities.

Core Responsibilities

• Support day-to-day operational execution of assigned clinical trials.
• Coordinate study-related activities among clinical sites, vendors, laboratories, and internal stakeholders.
• Assist with study start-up, site activation, protocol amendment implementation, and study closeout activities.
• Maintain study tracking tools, study dashboards, action item logs, and Trial Master File (TMF) documentation.
• Support investigational site communications and distribution of study documents.
• Coordinate investigator meetings, study team meetings, and vendor meetings, including preparation of agendas, minutes, and follow-up action items.
• Support implementation and tracking of protocol changes and operational plans.
• Coordinate patient scheduling activities associated with study procedures, leukapheresis collections, manufacturing timelines, treatment administration, and follow-up visits, as applicable.
• Maintain study scheduling trackers and communicate scheduling updates to relevant stakeholders.
• Support coordination of time-sensitive activities among sites, manufacturing partners, central laboratories, and logistics vendors.
• Escalate scheduling conflicts, delays, or operational risks to the Clinical Operations team.
• Coordinate collection, shipment, receipt, tracking, and reconciliation of study-related biological samples, including tumor tissue, blood, plasma, serum, PBMCs, and other translational samples.
• Maintain sample tracking systems to monitor sample collection status, shipment status, receipt confirmation, and data availability.
• Coordinate sample shipments to central laboratories and specialty testing vendors in accordance with study requirements.
• Ensure required sample documentation is complete and maintained.
• Support management of chain of identity (COI) and chain of custody (COC) documentation, where applicable.
• Assist sites and vendors with resolving sample-related operational issues.
• Track sample inventory and status across studies and communicate updates to study teams.
• Serve as an operational point of contact for central laboratories and study vendors.
• Track laboratory deliverables, sample analyses, and data transfers.
• Monitor vendor timelines and follow up on outstanding deliverables.
• Coordinate laboratory manual updates and support sample collection kit management activities.
• Support vendor onboarding, purchase order tracking, invoice processing, and contract-related administrative activities.
• Assist Clinical Operations with vendor oversight documentation and issue tracking.
• Maintain study trackers related to enrollment, sample management, vendor deliverables, and study milestones.
• Support reconciliation of laboratory and sample-related data.
• Assist with query resolution and documentation of sample-related deviations.
• Maintain study documentation in applicable systems and the Trial Master File.
• Support inspection readiness by ensuring complete and accurate study documentation.

Core Qualifications

• Bachelor's degree in life sciences, health sciences, or a related discipline preferred.
• 2+ years of experience supporting clinical research studies or clinical trial operations.
• Experience coordinating study activities across multiple stakeholders.
• Experience supporting sample management, laboratory operations, or biospecimen logistics preferred.
• Oncology clinical trial experience preferred.
• Experience working with CROs, central laboratories, or specialty vendors preferred.
• Strong organizational and project coordination skills.
• Ability to manage multiple competing priorities in a fast-paced environment.
• Excellent written and verbal communication skills.
• Strong attention to detail and documentation practices.
• Proficiency with Microsoft Office applications and clinical trial tracking tools.
• Experience coordinating time-sensitive clinical and sample management activities.
• Ability to work effectively across cross-functional teams and external partners.
• Scientifically rigorous in designing and executing experiments and record keeping.
• Excellent planning, coordination, and time management skills.
• Excellent oral, written, and visual communication skills.
• Ability to build and maintain productive relationships with department management, peers, and other colleagues across the organization.
• Collaborative and accountable.
• Self-motivated, with a proven ability to meet objectives, timelines, and high standards managing multiple responsibilities in parallel.
• Flexible - adapts to change in a fast paced, rapidly developing environment.
• Curious and humble - seeks and welcomes input/expertise of others, continuous learner.
• Tenacious and resilient - is not easily overwhelmed by challenges, delivers on commitments, operates with urgency.

Bonus Qualifications

• Experience in oncology, cell therapy, gene therapy, or immunotherapy clinical trials.
• Familiarity with biospecimen handling and shipment processes.
• Understanding of chain of identity (COI) and chain of custody (COC) principles.
• Experience supporting global clinical studies and complex vendor networks.