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Salary: USD 81,000 - 99,000 / annual
Obsidian Therapeutics is pioneering engineered cell and gene therapies, with a lead program in clinical development for metastatic melanoma and non-small cell lung cancer using their proprietary cytoDRiVE® platform.
As a Clinical Trial Coordinator, you will provide operational support for Obsidian's clinical studies, serving as a key contributor within Clinical Operations. You'll coordinate clinical trial activities, patient scheduling workflows, vendor interactions, and translational sample management to support the development of their first clinical-stage autologous cell therapy program targeting solid tumors.
Key responsibilities include:
- Support day-to-day operational execution of assigned clinical trials and 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, 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.
- Coordinate patient scheduling activities associated with study procedures, leukapheresis collections, manufacturing timelines, treatment administration, and follow-up visits.
- Maintain study scheduling trackers and communicate 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 (tumor tissue, blood, plasma, serum, PBMCs, and other translational samples).
- Maintain sample tracking systems to monitor 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, including chain of identity (COI) and chain of custody (COC) documentation.
- 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.
You will work closely with Clinical Operations, Clinical Science, Supply Chain & Logistics, Data Management, and external service providers. This is a hybrid role based in Bedford, MA, where Obsidian's Technical Operations team is located.
Requirements:
- Strong background in supporting clinical research studies or clinical trial operations.
- 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.
