Sample and Lab Coordinator (SLC)

SGS_JOB_3518

Business Support
 Massachusetts
Biospecimen Management
Laboratory Coordination
GLP/GCLP Compliance
Data Entry
Stakeholder Collaboration
QC
LIMS
Translational Medicine

Contract - 12 months Contract

Location (mandatory): Cambridge, MA, 02141 The Sample and Lab Coordinator (SLC) is responsible for the lifecycle management of biological samples across preclinical and clinical studies. This role combines strategic biospecimen oversight with hands-on laboratory coordination, ensuring compliance with GLP/GCLP, optimizing workflows, maintaining laboratory operations, and supporting translational medicine strategies. The SLC will collaborate with cross-functional teams and external partners to ensure timely and accurate sample handling and management.

Job Responsibilities:

  • Receive, record, store, dispose, and ship biological samples in compliance with GxP and internal procedures for Biomarker/CDx, pharmacokinetic (PK), and ADA samples.
  • Perform QC checks on shipment manifests and resolve discrepancies with stakeholders.
  • Ensure laboratory areas are maintained, and equipment is qualified, calibrated, and in good working order.
  • Manage laboratory consumables and inventory, maintaining accurate records.
  • Contribute to continuous improvement initiatives and process optimization.
  • Coordinate with clinical teams, research and development, bioanalytical/PK experts, and external partners for sample management.
  • Oversee Central Lab activities and support audits and inspections.
  • Maintain LIMS and central lab portals, assist with protocol reviews, and develop biospecimen documentation.

Skills:

  • Proficiency in biospecimen management, laboratory coordination, and GxP compliance.
  • Strong communication and interpersonal skills for cross-functional collaboration.
  • Expertise in LIMS (e.g., Watson LIMS) and bioanalytical methodologies.
  • Advanced proficiency in Excel and digital solutions for data analysis.
  • Organizational and project management skills.

Education/Experience:

  • Bachelor’s degree in life sciences (Biology, Pharmacy, Veterinary, or related discipline).
  • Minimum 2 years of experience in biospecimen management and/or laboratory coordination in a regulated environment (GLP, GCLP, ICH-GCP).
  • Proficiency in bioanalytical methodologies and regulatory requirements for drug development.
  • Excellent communication skills, proficiency in English (written and spoken).
  • Master’s degree in life sciences (Biology, Pharmacy, Veterinary, or related discipline).
  • Experience with translational medicine operations and clinical trials.
  • Knowledge of CDISC standards and controlled terminology.
  • Experience in preclinical study support and laboratory operations management.

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