Clinical Trial Coordinator

Obsidian Therapeutics, Inc.

Bedford (MA)

Hybrid

USD 65,000 - 92,000

Full time

13 days ago

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Job summary

Obsidian Therapeutics, Inc. is seeking a Clinical Trial Coordinator to support the operational execution of assigned clinical trials within the Clinical Operations Team.

You will coordinate activities across clinical sites, vendors, laboratories, and internal stakeholders to ensure smooth study progression. The role involves assisting with study start-up, site activation, protocol changes, and TMF documentation, while maintaining sample handling and communications across teams in a fast-paced

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.

Job description

About Us…

Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our cytoDRiVE® technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian’s lead program is currently in clinical development for the treatment of patients with metastatic melanoma and non‑small cell lung cancer.

We’re proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our Research team is based in the heart of Cambridge, MA, and Technical Operations team is based in our purpose built facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.

Our Opportunity...

We are looking for a highly motivated Clinical Trial Coordinator with a strong background in supporting clinical research studies or clinical trial operations. As a key contributor within Clinical Operations, you’ll provide operational support for Obsidian Therapeutics' clinical studies by coordinating clinical trial activities, patient scheduling workflows, vendor interactions, and translational sample management, helping to drive the development of our first clinical stage autologous cell therapy program targeting solid tumors.

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.

As a member of our Clinical Operations Team, you will be a vital part of a highly collaborative group working to unlock the promise of precision cell therapy for patients, starting with our lead program amsoki‑cel (OBX‑115), a novel engineered tumor‑infiltrating lymphocyte (TIL) cell therapy that uses our proprietary cytoDRiVE® platform. This is a unique opportunity to be a valuable contributor in a well‑funded clinical company with field‑leading advisors, best‑in‑class partners, and an experienced team.

This is a Hybrid role based out of our Bedford, MA location.
You Will...
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
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