Research Associate I

Job Title: Research Associate I – Translational Biology Job Description This Research Associate I role in Translational Biology focuses on clinical research support in a GCP/GLP environment, with a strong emphasis on clinical sample management, sample logistics, and coordination across internal teams and external partners. The position supports translational biology efforts for advanced therapeutic programs, including cell and gene therapy, and involves managing clinical and pre-clinical samples, maintaining documentation and databases, and contributing to high-quality laboratory operations and data integrity. Responsibilities Provide research and operational support for translational biology efforts across cell and gene therapy, RNA, siRNA, and gene editing programs. Facilitate clinical sample logistics and support clinical sample reconciliation, ensuring accurate paper and electronic record keeping. Manage and oversee the clinical sample management process, including the development and implementation of a centralized database for clinical samples and consent tracking. Perform day-to-day sample and database management, ensuring data accuracy, completeness, and traceability. Assist with coordination, distribution, and tracking of clinical trial supplies to domestic and international biopsy, surgical, and laboratory sites. Ensure compliance with GCP and GLP guidelines, as well as FDA regulations and ICH guidelines, in all aspects of sample handling and documentation. Maintain training manuals, materials, and resources for clinical trial biopsy sites, and support distribution of training materials related to sample management. Collaborate closely with Clinical Operations, Data Management, Biostatistics, and external vendors to support data transfer and analysis needs. Support communications and build productive relationships with key stakeholders, including CROs, specialty laboratory vendors, and external collaborators. Work with Laboratory Operations and Sample Management teams to track and reconcile incoming sample shipments across various clinical and pre-clinical studies. Assist laboratory teams in writing, reviewing, and updating SOPs, reports, and publications related to clinical analyses. Assist with tracking and reporting departmental metrics as applicable, contributing to continuous improvement of processes. Exercise discretion and sound judgment in handling confidential information and ensure strict adherence to all relevant regulatory and quality standards. Contribute to a collaborative, fast-paced team environment and actively participate in problem solving and process optimization. Essential Skills Bachelor’s degree in Biology, Biochemistry, or a related field. At least 2 years of hands-on clinical sample management or clinical research operations experience in a biotech or healthcare setting. Demonstrated experience working in a GCP/GLP environment. Strong technical proficiency and high-quality sample handling with strict adherence to laboratory SOPs. Ability to exercise discretion and judgment in handling confidential information. Working knowledge of and adherence to FDA regulations, ICH guidelines, and GCP in daily tasks. Strong organizational skills with the ability to balance and prioritize changing demands. Proven track record of effective teamwork and collaboration in cross-functional settings. Ability to communicate clearly across multiple parties and functional groups, including external stakeholders. Excellent technical writing skills, with the ability to articulate complex technical concepts to diverse audiences. Demonstrated problem-solving skills and the ability to address complex issues in a structured and timely manner. Additional Skills & Qualifications Background in biology, virology, molecular biology, or related scientific disciplines. Hands-on experience with PCR, ELISA, and other molecular biology techniques. Experience with animal research and working with AAV (adeno-associated virus) is highly beneficial. Experience supporting cell and gene therapy, RNA, siRNA, or gene editing programs. Experience in clinical sample logistics, including international site support and vendor coordination. Ability to develop new training materials and procedures for sample management and site operations. Comfort working in a dynamic, fast-paced environment with a strong desire to contribute to innovative medicines that improve patients’ lives. Work Environment The role is primarily based in a laboratory environment within a modern, state-of-the-art