Clinical Trial Coordinator at Obsidian Therapeutics

Bedford, MA (HYBRID)Full-timeClinical OperationsPosted 7 days ago

About the Role

<div class="content-intro">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.</div>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.      <div data-ccp-timestamp="1790967538683">This is a Hybrid role based out of our Bedford, MA location. </div> You Will... Core responsibilities <ul> <li>Support day-to-day operational execution of assigned clinical trials. </li> <li>Coordinate study-related activities among clinical sites, vendors, laboratories, and internal stakeholders. </li> <li>Assist with study start-up, site activation, protocol amendment implementation, and study closeout activities. </li> <li>Maintain study tracking tools, study dashboards, action item logs, and Trial Master File (TMF) documentation. </li> <li>Support investigational site communications and distribution of study documents. </li> <li>Coordinate investigator meetings, study team meetings, and vendor meetings, including preparation of agendas, minutes, and follow-up action items. </li> <li>Support implementation and tracking of protocol changes and operational plans. </li> <li>Coordinate patient scheduling activities associated with study procedures, leukapheresis collections, manufacturing timelines, treatment administration, and follow-up visits, as applicable. </li> <li>Maintain study scheduling trackers and communicate scheduling updates to relevant stakeholders. </li> <li>Support coordination of time-sensitive activities among sites, manufacturing partners, central laboratories, and logistics vendors. </li> <li>Escalate scheduling conflicts, delays, or operational risks to the Clinical Operations team. </li> <li>Coordinate collection, shipment, receipt, tracking, and reconciliation of study-related biological samples, including tumor tissue, blood, plasma, serum, PBMCs, and other translational samples. </li> <li>Maintain sample tracking systems to monitor sample collection status, shipment status, receipt confirmation, and data availability. </li> <li>Coordinate sample shipments to central laboratories and specialty testing vendors in accordance with study requirements. </li> <li>Ensure required sample documentation is complete and maintained. </li> <li>Support management of chain of identity (COI) and chain of custody (COC) documentation, where applicable. </li> <li>Assist sites and vendors with resolving sample-related operational issues. </li> <li>Track sample inventory and status across studies and communicate updates to study teams. </li> <li>Serve as an operational point of contact for central laboratories and study vendors. </li> <li>Track laboratory deliverables, sample analyses, and data transfers. </li> <li>Monitor vendor timelines and follow up on outstanding deliverables. </li> <li>Coordinate laboratory manual updates and support sample collection kit management activities. </li> <li>Support vendor onboarding, purchase order tracking, invoice processing, and contract-related administrative activities. </li> <li>Assist Clinical Operations with vendor oversight documentation and issue tracking. </li> <li>Maintain study trackers related to enrollment, sample management, vendor deliverables, and study milestones. </li> <li>Support reconciliation of laboratory and sample-related data. </li> <li>Assist with query resolution and documentation of sample-related deviations. </li> <li>Maintain study documentation in applicable systems and the Trial Master File. </li> <li>Support inspection readiness by ensuring complete and accurate study documentation. </li> </ul> You Bring... Core Qualifications <ul> <li>Bachelor’s degree in life sciences, health sciences, or a related discipline preferred. </li> <li>2+ years of experience supporting clinical research studies or clinical trial operations. </li> <li>Experience coordinating study activities across multiple stakeholders. </li> <li>Experience supporting sample management, laboratory operations, or biospecimen logistics preferred. </li> <li>Oncology clinical trial experience preferred. </li> <li>Experience working with CROs, central laboratories, or specialty vendors preferred. </li> <li>Strong organizational and project coordination skills. </li> <li>Ability to manage multiple competing priorities in a fast-paced environment. </li> <li>Excellent written and verbal communication skills. </li> <li>Strong attention to detail and documentation practices. </li> <li>Proficiency with Microsoft Office applications and clinical trial tracking tools. </li> <li>Experience coordinating time-sensitive clinical and sample management activities. </li> <li>Ability to work effectively across cross-functional teams and external partners. </li> <li><span data-ccp-charstyle="normaltextrun" data-ccp-charstyle-defn="{"ObjectId":"ac0262f4-8a9e-5820-b908-2d943c5f7113|1","ClassId":1073872969,"Properties":[201342446,"1",201342447,"5",201342448,"1",201342449,"1",469777841,"Calibri",469777842,"Arial",469777843,"Calibri",469777844,"Calibri",201341986,"1",469769226,"Calibri,Arial",268442635,"22",469775450,"normaltextrun",201340122,"1",134233614,"true",469778129,"normaltextrun",335572020,"1",469778324,"Default Paragraph Font"]}">Scientifically rigorous in designing and executing experiments and record keeping.  </li> <li>Excellent planning, coordination, and time management skills   </li> <li>Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership.   </li> <li>Ability to build and maintain productive relationships with department management, peers, and other colleagues across the organization   </li> <li><span data-ccp-charstyle="normaltextrun" data-ccp-charstyle-defn="{"ObjectId":"ac0262f4-8a9e-5820-b908-2d943c5f7113|1","ClassId":1073872969,"Properties":[201342446,"1",201342447,"5",201342448,"1",201342449,"1",469777841,"Calibri",469777842,"Arial",469777843,"Calibri",469777844,"Calibri",201341986,"1",469769226,"Calibri,Arial",268442635,"22",469775450,"normaltextrun",201340122,"1",134233614,"true",469778129,"normaltextrun",335572020,"1",469778324,"Default Paragraph Font"]}">Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; shares feedback and ideas to facilitate better outcomes  </li> <li>Self-motivated, with a proven ability to meet objectives, timelines, and high standards managing multiple responsibilities in parallel.    </li> <li>Flexible - adapts to change in a fast paced, rapidly developing environment  </li> <li>Curious and humble – seeks and welcomes input/expertise of others, continuous learner  </li> <li>Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments, operates with urgency </li> </ul> Bonus Qualifications <ul> <li>Experience in oncology, cell therapy, gene therapy, or immunotherapy clinical trials. </li> <li>Familiarity with biospecimen handling and shipment processes. </li> <li>Understanding of chain of identity (COI) and chain of custody (COC) principles. </li> <li>Experience supporting global clinical studies and complex vendor networks. </li> </ul><div class="content-pay-transparency"><div class="pay-input"><div class="description">Obsidian is committed to equitable and transparent pay practices. The anticipated base salary range for this role is below. The actual base salary offered will be determined based on a combination of factors, including applicable qualifications, level of education, the depth of experience, unique skills, geographic location, internal equity, and/or business needs. The actual base salary offered will be in accordance with federal, state, and/or local wage requirements for the role’s location. Our competitive compensation package includes an annual incentive bonus as a percentage of actual base salary and long-term incentives in the form of employee stock options, both of which are commensurate with the role’s level. We also offer a generous benefits package which includes comprehensive medical, dental, and vision coverage; company contributions to health savings and retirement accounts; ample paid time off; access to wellness programs; and rich career growth opportunities.</div><div class="title">Anticipated Base Salary Range</div><div class="pay-range">$81,000—$99,000 USD</div></div></div><div class="content-conclusion">Obsidian is proud to be an equal opportunity employer, cultivating a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.</div>

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