Research Associate II

We are currently hiring multiple Research Associate I and II roles in Columbus. These are 1st shift positions and will be supporting a biologics/cell & gene therapy company.

The Research Associate II provides critical clinical research support within a GCP/GLP environment, focusing on clinical sample management, logistics, and documentation for translational biology programs. This role collaborates closely with internal teams and external partners to manage biopsy and laboratory site needs, oversee sample tracking across multiple studies, and maintain centralized databases and training records. The position plays a key role in supporting RNA, siRNA, gene therapy, and genome editing programs by ensuring high-quality sample handling, accurate documentation, and compliant operations in a dynamic, fast-paced setting.

• Support translational biology efforts for RNA, siRNA, gene therapy, and genome editing programs by ensuring accurate and compliant clinical sample management.
• Facilitate sample logistics and assist with clinical sample reconciliation, including both paper-based and electronic record keeping.
• Organize, harmonize, and maintain clinical sample documentation to ensure consistency and completeness across studies.
• Manage and oversee the sample management process, including development and implementation of a centralized database for clinical samples and consent tracking.
• Perform data entry, tracking, and database management related to clinical samples and associated documentation.
• Assist with coordination and tracking of clinical trial supplies to ensure timely availability for biopsy and laboratory sites.
• Ensure adherence to GCP and GLP guidelines in all aspects of clinical sample handling, documentation, and operations.
• Maintain training manuals, resources, and documentation records for clinical trial biopsy and laboratory sites.
• Review, edit, and upload clinical and operational documents into a central database, ensuring accuracy and version control.
• Collaborate 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 contract research organizations, vendors, and external collaborators.
• Assist laboratory teams with writing and reviewing standard operating procedures (SOPs), reports, and publications related to clinical analyses.
• Contribute to the tracking and reporting of departmental metrics, helping to monitor performance and operational efficiency.
• Assist with vendor management for specialty laboratory vendors, including support for budget projections and forecasting related to sample management activities.
• Work closely with Laboratory Operations and Sample Management teams to track and reconcile incoming sample shipments across clinical and pre-clinical studies.

• B.S. degree in Biology, Biochemistry, or a related field.
• At least 1-3 years of hands‑on clinical sample management or clinical research operations experience in a biotech or healthcare setting.
• Experience working in a GCP/GLP environment with strict adherence to regulatory and quality standards.
• Ability to exercise discretion and judgment in handling confidential information while following FDA regulations, ICH guidelines, and GCP in all tasks.
• Strong organizational skills with the ability to balance changing priorities and manage multiple concurrent activities.
• Demonstrated technical proficiency and high‑quality sample handling with strict adherence to laboratory SOPs.
• Proven track record of effective teamwork and collaboration across multidisciplinary groups.
• Ability and desire to work in a dynamic, fast‑paced team…