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Obsidian Therapeutics
Obsidian Therapeutics
51 – 200 Angajați
Sponsor pentru viza H1BAsistență medicalăConsultanțăIndustria prelucrătoare
Obsidian Therapeutics este o companie de biotehnologie care dezvoltă terapii celulare și genice de precizie pentru boli grave, cu nevoi medicale semnificative încă nesoluționate. Platforma sa cytoDRiVE® este concepută pentru a regla activitatea proteinelor terapeutice, sprijinind dezvoltarea unor medicamente țintite. Portofoliul de cercetare al companiei include OBX-115 pentru melanom avansat, care a primit din partea FDA desemnările Regenerative Medicine Advanced Therapy și Fast Track.
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Locurile de muncă ale companiei

Clinical Trial Coordinator - Hybrid | Obsidian Therapeutics

Support Obsidian Therapeutics’ engineered cell and gene therapy trials by coordinating clinical sites, patient scheduling, vendors, and biospecimen logistics.

USStatele Unite ale AmericiiMAMassachusetts
81.000 $ – 99.000 $ / an
HibridNormă întreagăJuniorNivel mediuNu este necesară o diplomăLimbă Obligatorie: englezăCoordonator de studii cliniceGeneral

Descriere

  • Manage daily operational activities for assigned clinical trials
  • Coordinate study work across clinical sites, vendors, laboratories, and internal teams
  • Support study start-up, site activation, protocol amendments, and closeout activities
  • Maintain study trackers, dashboards, action logs, and Trial Master File records
  • Support site communications and distribution of study documents
  • Coordinate investigator, study team, and vendor meetings, including agendas, minutes, and follow-up actions
  • Support the implementation and monitoring of protocol changes and operational plans
  • Coordinate patient scheduling for procedures, leukapheresis, manufacturing, treatment, and follow-up visits
  • Maintain scheduling trackers and share updates with stakeholders
  • Coordinate time-sensitive work among sites, manufacturing partners, central laboratories, and logistics vendors
  • Escalate scheduling conflicts, delays, and operational risks
  • Coordinate the collection, shipment, receipt, tracking, and reconciliation of biological and translational samples
  • Maintain sample tracking systems and monitor sample status, receipt confirmations, and data availability
  • Coordinate shipments to central laboratories and specialty testing vendors
  • Maintain sample records and support chain-of-identity and chain-of-custody documentation
  • Resolve sample-related operational issues with sites and vendors
  • Track sample inventory, laboratory deliverables, analyses, and data transfers
  • Monitor vendor timelines and pending deliverables
  • Coordinate laboratory manual updates and sample collection kit management
  • Support vendor onboarding, purchase order tracking, invoice processing, and contract administration
  • Assist with vendor oversight records and issue tracking
  • Maintain trackers for 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
  • Maintain study records and support inspection readiness

Cerințe

  • At least two years of experience supporting clinical research studies or trial operations
  • Experience coordinating study activities across multiple stakeholders
  • Strong organizational and project coordination abilities
  • Ability to manage competing priorities in a fast-moving environment
  • Excellent written and verbal communication skills
  • Thorough approach to documentation and detail management
  • Proficiency with Microsoft Office and clinical trial tracking systems
  • Experience coordinating time-sensitive clinical and sample management activities
  • Ability to collaborate effectively with cross-functional teams and external partners
  • Bachelor’s degree in life sciences, health sciences, or a related field preferred
  • Experience with sample management, laboratory operations, or biospecimen logistics preferred
  • Oncology clinical trial experience preferred
  • Experience working with CROs, central laboratories, or specialty vendors preferred
  • Scientifically rigorous approach to experiment execution and record keeping
  • Strong planning, coordination, and time management skills
  • Ability to develop and sustain productive organizational relationships
  • Self-directed record of meeting objectives, timelines, and high standards while managing parallel responsibilities
  • Adaptable and flexible in a rapidly evolving environment
  • Experience in oncology, cell therapy, gene therapy, or immunotherapy trials is a bonus
  • Familiarity with biospecimen handling and shipment processes is a bonus
  • Understanding of chain-of-identity and chain-of-custody principles is a bonus
  • Experience supporting global clinical studies and complex vendor networks is a bonus

Beneficii

  • Annual incentive bonus based on actual base salary
  • Long-term incentives through employee stock options
  • Medical, dental, and vision coverage
  • Company contributions to health savings and retirement accounts
  • Paid time off
  • Wellness program access
  • Career development opportunities
  • Salary and benefits package
  • Potential equity ownership through stock options

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