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This position supports clinical and translational research activities for advanced therapeutic programs, with a focus on biological sample operations, data integrity, and cross-functional coordination. The role plays a key part in ensuring clinical materials and associated data are managed accurately, compliantly, and efficiently across studies.
Job Responsibility
Support clinical and translational research initiatives related to novel modality programs, including gene-based and RNA-focused therapies
Coordinate the movement, tracking, and reconciliation of biological samples associated with clinical studies
Maintain accurate documentation and records within both electronic systems and controlled paper files
Contribute to the design, rollout, and ongoing maintenance of centralized systems used for sample inventory, consent status, and tracking
Oversee day-to-day sample lifecycle activities, ensuring traceability and data accuracy
Assist with logistics and accountability for clinical study materials and supplies
Perform work in alignment with applicable regulatory standards, including GCP and GLP requirements
Develop, update, and organize materials and training resources used by clinical collection sites
Work closely with internal teams and external partners to support data exchange, downstream analysis, and operational reporting
Serve as a point of contact for coordination with vendors, service providers, and research collaborators
Support laboratory and clinical teams by contributing to technical documentation, procedural updates, and study-related reports
Collect, organize, and report operational metrics to support continuous process improvement
Requirements
Bachelor's degree in a life science discipline (e.g., biology, biochemistry, or similar)
At least 2 years of experience supporting clinical research activities, sample operations, or research operations within a regulated environment
Familiarity working under FDA, ICH, and GCP/GLP guidelines
Demonstrated ability to manage confidential and sensitive information responsibly
Strong organizational and prioritization skills with comfort working in a changing, deadline-driven setting
Proven attention to detail in handling clinical or research samples in accordance with controlled procedures
Collaborative working style with the ability to engage effectively across multiple functional teams
Clear verbal and written communicator, capable of translating technical concepts for varied audiences
Experience contributing to process documentation, training materials, or procedural improvements
Motivation to work within a fast-moving research environment focused on advancing patient-impacting therapies