Sample and Lab Coordinator (SLC)

Immediate need for a talented Sample and Lab Coordinator (SLC) . This is a  11+ months contract opportunity with long-term potential and is located in Cambridge, MA (Onsite). Please review the job description below and contact me ASAP if you are interested.

Job Diva ID:  26-04454

Pay Range: $30  - $ 32/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
 
Key Responsibilities: -

• Laboratory Coordination & Quality Assurance
• Receive, record, store, dispose, and ship biological samples on site in compliance with GxP and internal procedures (OPEs, GOPs, SOPs) for Biomarker/Companion Diagnostics (CDx), pharmacokinetic (PK), anti-drug antibodies (ADA) samples.
• Perform QC checks on shipment manifests prior to LIMS import; investigate and resolve discrepancies with stakeholders.
• Ensure laboratory/work areas are maintained on company’s site and equipment is qualified, calibrated, and in good working order.
• Manage laboratory consumables and inventory; maintain accurate records of receipts and shipments in notebooks and digital systems.
• Contribute to continuous improvement initiatives; propose technical and organizational enhancements and participate in process optimization working groups.
• Stakeholder Collaboration
• Coordinate among clinical teams, research and development teams, bioanalytical/PK experts, outsourcing/clinical operations, and external partners (e.g., Central Labs, clinical research organizations, assay laboratories).
• Oversee Central Lab activities including shipment of biospecimens to analytical laboratories to ensure timely delivery and analyzable quality.
• Support audits and inspections; act as spokesperson for sample-related processes and documentation.

Key Requirements and Technology Experience: 

• Key skills: - 2 years. lab based, receive samples and store them, also require data entry, communicating with stakeholders for QC.
• Masters degree and recently out of school would be fine but Bach degree would prefer 2 years work exp.
• Must Haves/Required Skills: Basic understanding clinical trials Clinical research
• Bachelor’s degree in life sciences (Biology, Pharmacy, Veterinary, or related discipline) with minimum 2 years of experience in biospecimen management and/or laboratory coordination within a regulated environment (GLP, GCLP, ICH-GCP).
• Working knowledge of bioanalytical methodologies and regulatory requirements for drug development.
• Proficiency with GxP-compliant digital solutions for data analysis and laboratory documentation.
• organizational and project management skills are plus; ability to manage multiple priorities with high accuracy.
• Excellent communication and interpersonal skills for cross-functional collaboration.
• Proficient English (written and spoken); advanced proficiency in Excel.
• Master’s degree in life sciences (Biology, Pharmacy, Veterinary, or related discipline).
• Expertise in LIMS (e.g., Watson LIMS) for study setup, sample registration, tracking, and storage.
• Experience with translational medicine operations (Biomarker/CDx, PK, ADA, ADC) in clinical trials.
• Experience with sample reconciliation between bioanalytical LIMS and clinical databases.
• Knowledge of CDISC standards and controlled terminology (SDTM/SEND).
• Experience in preclinical study support and laboratory operations management.
• Prior hands-on laboratory experience.

Our client is a leading Pharmaceuticals Industry , and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration

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