Obsidian Therapeutics Cambridge , MA 02138
Posted 2 weeks ago
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
Work location: Hybrid role based in Cambridge, MA
Obsidian Therapeutics