Research Associate

Role Overview

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.

Core Responsibilities

• 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.

Background & Experience

• 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.