Research Associate II (Clinical Research Sample Management)

WaveCrest Staffing Group; Columbus (OH); On-site; USD 45,000 - 50,000; Full time

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

Research Associate II – Clinical Sample Management

Location: Columbus, OH

Pay Rate: $33.00-$36.60/hour

Schedule: 1st Shift | Onsite

Duration: 1-Year Contract with Likelihood of Extension and/or Conversion

Start Date: ASAP

Position Overview

We are seeking a Research Associate II to support clinical research and translational biology programs within a fast-paced biotechnology environment. This position will focus on clinical sample management, sample logistics, documentation, database management, and coordination with internal teams, clinical sites, and external laboratory vendors.

The Research Associate II will support programs involving Gene Therapy, RNA, siRNA, and Gene Editing while ensuring clinical samples and associated documentation are properly tracked, reconciled, and maintained in accordance with GCP/GLP requirements.

Key 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.

Qualifications

• Bachelor's degree in Biology, Biochemistry, or a related scientific discipline.
• 3+ years of experience in clinical sample management, clinical research operations, or a related biotech/healthcare environment.
• Previous experience working within a GCP and/or GLP-regulated environment.
• Experience with clinical sample tracking, reconciliation, logistics, and database management strongly preferred.
• Understanding of FDA regulations, ICH guidelines, and clinical research documentation requirements.
• Strong organizational skills with the ability to manage multiple priorities and timelines.
• Excellent attention to detail and strong documentation skills.
• Strong technical writing and communication skills.
• Ability to effectively collaborate with internal teams, clinical sites, CROs, laboratory vendors, and other external partners.
• Comfortable working in a dynamic, fast-paced research environment.

This is a 1-year contract opportunity with a strong likelihood of extension and/or conversion based on business needs and performance. #INDBH