Sample and Lab Coordinator (SLC)
Spectraforce
Cambridge, Massachusetts
3 hours ago
Job Description
Position Title: Sample and Lab Coordinator (SLC)
Work Location: Cambridge, MA 02141
Assignment Duration: 11 months
HM Notes:
Fully onsite. 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
Position Summary
The SLC is responsible for the end-to-end lifecycle of biological samples across preclinical and clinical studies on company’s site, combining strategic oversight (biospecimen management) with hands-on operational execution (laboratory coordination, including on site instrument maintenance and receiving, accession, storage, and disposal of samples). The role ensures compliance with GLP/GCLP and internal SOPs, optimizes biospecimen workflows, maintains laboratory operations and inventory, and supports translational medicine strategies (e.g., Biomarker/CDx, PK, ADA, ADC) and working closely with sample managers to align with study timelines and global standards.
Key Responsibilities
1) 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.
2) 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.
Additional responsibilities:
Contribute to biospecimen governance and study readiness by maintaining LIMS and central lab portals, supporting protocol and ICF reviews, and assisting in the development and maintenance of biospecimen documentation (e.g., Sample Management Plans, central lab documents, kit contents).
Required Qualifications
• 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.
Preferred Qualifications
• 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.
Core Competencies
• Accountability and sound judgment; understands impact of decisions in regulated settings.
• Continuous improvement mindset; proactive problem-solving and risk mitigation.
• Team player: able to work in cross-functional global teams and share knowledge/expertise.
• Self-motivated and adaptable; comfortable working in complex environments.
Work Conditions
• Hybrid responsibilities combining strategic Biospecimen management and hands-on laboratory coordination.
• Onsite presence required for laboratory activities, equipment oversight, and sample handling.
Occasional travel may be required for audits, vendor visits, or cross-site collaboration.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 30.00/hr.
Work Location: Cambridge, MA 02141
Assignment Duration: 11 months
| 1st | ||
|---|---|---|---|
| 8 am -4 PM Mon-Fri |
HM Notes:
Fully onsite. 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
Position Summary
The SLC is responsible for the end-to-end lifecycle of biological samples across preclinical and clinical studies on company’s site, combining strategic oversight (biospecimen management) with hands-on operational execution (laboratory coordination, including on site instrument maintenance and receiving, accession, storage, and disposal of samples). The role ensures compliance with GLP/GCLP and internal SOPs, optimizes biospecimen workflows, maintains laboratory operations and inventory, and supports translational medicine strategies (e.g., Biomarker/CDx, PK, ADA, ADC) and working closely with sample managers to align with study timelines and global standards.
Key Responsibilities
1) 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.
2) 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.
Additional responsibilities:
Contribute to biospecimen governance and study readiness by maintaining LIMS and central lab portals, supporting protocol and ICF reviews, and assisting in the development and maintenance of biospecimen documentation (e.g., Sample Management Plans, central lab documents, kit contents).
Required Qualifications
• 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.
Preferred Qualifications
• 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.
Core Competencies
• Accountability and sound judgment; understands impact of decisions in regulated settings.
• Continuous improvement mindset; proactive problem-solving and risk mitigation.
• Team player: able to work in cross-functional global teams and share knowledge/expertise.
• Self-motivated and adaptable; comfortable working in complex environments.
Work Conditions
• Hybrid responsibilities combining strategic Biospecimen management and hands-on laboratory coordination.
• Onsite presence required for laboratory activities, equipment oversight, and sample handling.
Occasional travel may be required for audits, vendor visits, or cross-site collaboration.
Applicant Notices & Disclaimers
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 30.00/hr.