Contract, Research Associate I, Translational Biology

Location: Columbus, OH • Work Arrangement: 100% Onsite

About the role

We are seeking a motivated Research Associate I to support Translational Biology initiatives across Gene Therapy, RNA, siRNA, and Gene Editing programs. This role plays a critical part in clinical sample management, laboratory operations, and clinical research support activities. The successful candidate will collaborate with internal teams, external laboratories, clinical sites, CROs, and vendors to ensure efficient sample logistics, data integrity, and regulatory compliance.

This position is ideal for a detail-oriented professional with experience in clinical research operations or clinical sample management within a GCP/GLP-regulated environment.

Responsibilities

• Coordinate and facilitate clinical sample logistics and reconciliation activities.
• Maintain accurate paper and electronic records related to sample management.
• Track, reconcile, and monitor incoming sample shipments across clinical and preclinical studies.
• Manage sample tracking, database maintenance, and consent tracking processes.
• Support the development and implementation of centralized systems for sample management.
• Assist with coordination, distribution, and tracking of clinical trial supplies.
• Support domestic and international biopsy surgical and laboratory sites.
• Maintain training documentation, manuals, and educational resources for clinical trial biopsy sites.
• Distribute and track training materials related to sample management activities.
• Partner with Clinical Operations, Data Management, Biostatistics, and external vendors to support data transfer and analysis activities.
• Collaborate with CROs, specialty laboratory vendors, and external stakeholders to ensure smooth operational execution.
• Build and maintain productive working relationships with key internal and external partners.
• Ensure adherence to GCP, GLP, FDA regulations, and ICH guidelines.
• Assist laboratory teams with drafting, reviewing, and maintaining SOPs, reports, and scientific documentation.
• Support document harmonization efforts and regulatory readiness.
• Monitor and track departmental metrics as needed.

Qualifications

Education
Bachelor's degree in Biology, Biochemistry, or a related scientific discipline.

Experience
Minimum of 2 years of hands-on experience in clinical sample management, laboratory operations, or clinical research support within a biotech, pharmaceutical, healthcare, or related regulated environment.
Experience working in GCP and/or GLP environments.

Skills

• Strong knowledge of GCP, GLP, FDA regulations, and ICH guidelines.
• Demonstrated experience handling confidential information with professionalism and discretion.
• Excellent organizational and time-management skills, with the ability to manage multiple priorities in a fast-paced environment.
• Proven attention to detail and commitment to data accuracy and sample integrity.
• Experience maintaining databases, records, and tracking systems.
• Strong problem-solving and critical-thinking abilities.
• Effective verbal and written communication skills, including technical writing experience.
• Ability to develop training materials, procedures, and process documentation.
• Collaborative team player with a track record of building strong cross-functional relationships.

Benefits

• Health coverage
• Life insurance
• Disability insurance
• 401k benefits