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Clinical Research Associate (Sample Management)

$27 - $29 per hour
Full-time

Astrix Inc

Pay Rate Low: 26 | Pay Rate High: 29
Research Associate I

Location: Columbus, OH - 100% Onsite
Pay Rate: $27-$29/hour
Contract: 1 year contract (possibility of extension and/or conversion to permanent)
Start Date: ASAP - ideally by the end of August

About the Role

Our client is seeking a motivated Research Associate to support clinical research operations and sample management within a GCP/GLP environment . This role will work closely with internal teams, clinical and laboratory sites, CROs, vendors, and external collaborators to support sample logistics, documentation, database management, and day-to-day clinical research activities.

The Research Associate will help support domestic and international biopsy surgical and laboratory sites, coordinate sample shipments and tracking, maintain training documentation, and assist with specialty laboratory vendor management. This position will collaborate closely with the Laboratory Operations and Sample Management teams across clinical and pre-clinical studies.

Key Responsibilities

  • Support translational biology programs involving Gene Therapy, RNA, siRNA, and Gene Editing .
  • Coordinate clinical sample logistics , including tracking, reconciliation, and paper/electronic recordkeeping.
  • Manage sample tracking and consent information within centralized databases.
  • Assist with the development and implementation of sample management processes and databases .
  • Coordinate and track clinical trial supplies.
  • Track and reconcile incoming sample shipments across clinical and pre-clinical studies.
  • Maintain compliance with GCP/GLP guidelines, FDA regulations, and ICH guidelines .
  • Develop and maintain training manuals, resources, and documentation for clinical trial biopsy sites.
  • Collaborate with Clinical Operations, Data Management, Biostatistics, CROs, vendors, and external collaborators .
  • Support data transfers and analysis needs.
  • Build and maintain effective relationships with key internal and external stakeholders.
  • Assist laboratory teams with writing and reviewing SOPs, reports, and publications related to clinical analyses.
  • Support departmental metrics and reporting as needed.
  • Help identify and resolve complex sample management and operational issues.

Qualifications

  • Bachelor's degree in Biology, Biochemistry, or a related scientific field.
  • 2+ years of hands-on clinical sample management or clinical research operations experience within a biotech or healthcare environment.
  • Experience working in a GCP/GLP-regulated environment .
  • Strong understanding of laboratory SOPs and quality requirements for sample handling.
  • Ability to handle confidential information with discretion and sound judgment.
  • Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.
  • Excellent written and verbal communication skills.
  • Ability to communicate complex technical information clearly to both internal teams and external stakeholders.
  • Strong teamwork and collaboration skills.
  • Demonstrated problem-solving abilities and attention to detail.
  • Experience developing or maintaining training materials, procedures, and documentation is preferred.
  • Ability and willingness to work 100% onsite in Columbus, OH .
  • Must be available to start ASAP, ideally by the end of August.

INDBH
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Vacancy posted 1 day ago
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