Clinical Sample Management Specialist II – Onsite

WaveCrest Staffing Group

Columbus (OH)

On-site

USD 45,000 - 50,000

Full time

6 days ago
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Job summary

WaveCrest Staffing Group seeks a Research Associate II to support clinical sample management, logistics, documentation, and database upkeep in a fast-paced biotech setting. The role focuses on coordinating sample shipments, site/vendor interactions, and ensuring records comply with GCP/GLP standards.

The ideal candidate has a biology/biochemistry background with 3+ years in clinical sample management, strong organizational skills, and excellent documentation and communication abilities for

Qualifications

  • Bachelor's degree in Biology, Biochemistry, or related field.
  • 3+ years of experience in clinical sample management or related biotech operations.
  • Experience in GCP/GLP-regulated environments.
  • Experience with clinical sample tracking, logistics, and database management.
  • Strong organizational, documentation, and communication skills.

Responsibilities

  • Coordinate clinical and preclinical sample logistics, including tracking and reconciliation of incoming sample shipments.
  • Maintain accurate paper and electronic records related to clinical samples, consent tracking, and sample inventory.
  • Organize, review, and harmonize clinical sample documentation.
  • Maintain centralized databases used to track samples across multiple studies and sample types.
  • Assist with sample preparation and day-to-day laboratory/sample management activities.
  • Coordinate and track clinical trial supplies for domestic and international biopsy and laboratory sites.
  • Maintain and distribute training materials and documentation for clinical trial biopsy sites.
  • Review, edit, and upload study documentation into centralized databases.
  • Ensure activities are performed in accordance with GCP, GLP, FDA, ICH, and internal SOP requirements.
  • Collaborate with Clinical Operations, Laboratory Operations, Sample Management, Data Management, Biostatistics, CROs, and external vendors.
  • Support specialty laboratory vendor management, including budget projections and forecasting.
  • Assist laboratory teams with writing and reviewing SOPs, reports, and other clinical analysis documentation.
  • Track departmental metrics and support continuous process improvements.

Skills

Organizational skills
Technical writing
Communication skills
Detail-oriented

Education

Bachelor's degree in Biology/Biochemistry or related field

Tools

LIMS (Laboratory Information Management System)

Job description

WaveCrest Staffing Group seeks a Research Associate II to support clinical sample management, logistics, documentation, and database upkeep in a fast-paced biotech setting. The role focuses on coordinating sample shipments, site/vendor interactions, and ensuring records comply with GCP/GLP standards.

The ideal candidate has a biology/biochemistry background with 3+ years in clinical sample management, strong organizational skills, and excellent documentation and communication abilities for

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