Clinical Trial Associate

1 month ago

Cambridge, United States Obsidian Therapeutics Full time

Our Opportunity…

Obsidian Therapeutics is seeking a Clinical Trial Associate to work alongside the Clinical Development/Operations team to drive forward our clinical trials (currently recruiting patients with metastatic melanoma and non-small cell lung cancer). We're seeking a candidate with 1-3 years of experience in clinical trials, strong attention to detail, exceptional communication, and organizational skills, who thrives in a dynamic environment managing multiple tasks simultaneously.

As part of our Clinical Operations Department, you'll be a vital part of a highly collaborative team working to achieve Obsidian's vision by translating innovative science into medical breakthroughs for patients, starting with our lead program OBX-115.

This is a unique opportunity to be a contributor in a well-funded clinical company with blue chip investors, field-leading advisors, best-in-class partners, and an experienced team. You'll help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need.

You Will…

* Support the clinical study teams in the execution and delivery of studies.
* Organize, manage, and oversee the Trial Master File to maintain up-to-date regulatory documentation for all research sites.
* Be responsible for study laboratory sample management, including tracking and vendor management support.
* Collect trial information and disseminate it to the internal project team, the CRO, and other stakeholders.
* Schedule and coordinate internal and external study meetings, materials, and agendas; record and disseminate resulting decisions and actions.
* Be responsible for quality control of the eTMF including maintenance and oversight.
* Coordinate and manage version control of clinical documents.
* Assist in the coordination and tracking of clinical supply shipments with external parties.
* Assist in the creation and updating of standardized clinical trial tools, processes, and SOPs for the clinical operations team and cross functionally as needed.
* Organize and maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out.
* Act as a contact for the study team for designated project communications, correspondence, and associated documentation.
* Assist with invoice tracking, PO creation, and budget management.
* Ensure inspection readiness and provide support to sites to prepare for clinical audits/inspections.
* Prepare and maintain assigned program files.
* Perform administrative tasks to support team members with clinical trial execution, as needed.

You Bring…

Core Qualifications

* BS/BA/RN Degree in a life science or a health-related field is preferred.
* Minimum of at least 1-3 years working on phase I-IV clinical studies within a biopharmaceutical/biotech, CRO, or academic environment.
* Experience and understanding of clinical trial operations, preferably in the oncology and/or cell therapy space.
* Solid knowledge of ICH/GCP and regulatory requirements.
* Enthusiasm for, and successful experience in a fast-paced and evolving environment.
* Proficiency in MS Office Suite (Word, Excel, PowerPoint).
* Exceptional organizational skills and attention to quality and detail.
* Established ability to prioritize and manage multiple tasks simultaneously, identify and resolve issues, and effectively manage timelines to deliver on commitments.
* Experience collaborating in inter-departmental workgroups to create or enhance processes.
* Strong customer service orientation.

Bonus Qualifications

* Proficiency in Microsoft Project and project management programs.

Work location: Hybrid role based in Cambridge, MA

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