Research Associate II

About the role

Research Associate I and II positions supporting a biologics/cell & gene therapy company in Columbus, OH. This is a contract role, fully onsite.

Responsibilities

• 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.