PBMC Lab Coordinator

2 months ago

Houston, United States DM Clinical Research Full time
Job DescriptionJob DescriptionPBMC Lab Coordinator

A PBMC Lab Coordinator will be primarily responsible to travel to new sites to set up Research and PBMC labs, train the new staff in addition to maintaining existing PBMC and research labs and training existing staff. Set up, provide oversight and training for special laboratory procedures for clinical trials, performing high complexity laboratory techniques including but not limited to routine isolation of peripheral blood mononuclear cells (PBMC), flow cytometry, and DNA/RNA isolation, etc., ensuring safety measures are followed by facilitating laboratory operations.

DUTIES & RESPONSIBILITIES
  • Travel to new sites to set up clinical research and PBMC labs and train new staff on PBMC and research lab procedures, lab safety, and quality control measures.
  • Work with site development team to assess laboratory needs and follow specific Sponsor protocols to meet processing requirements.
  • Maintain and assist in supervising existing research and PBMC labs, including inventory management, equipment maintenance, and scheduling of lab activities.
  • Train staff on laboratory procedures, safety protocols, and quality control measures.
  • Ensure compliance with all regulatory requirements, including FDA, GCP, and CLIA. 6. Troubleshoot technical issues and provide solutions to maintain lab productivity and efficiency. Maintain accurate and detailed documentation of lab activities and results.
  • Perform PBMC sample processing and cryopreservation as well as Prepare, process, and ship laboratory samples to outside laboratories following IATA regulations.
  • Maintain specimen integrity by using an aseptic technique, following protocol procedures; observing isolation procedures.
  • Track collected specimens by initialing, dating, and noting times of collection; maintaining daily tallies of collections performed as applicable.
  • Protect the safety and welfare of the study subjects by ensuring that the study is conducted properly and in compliance with ICH/GCP and Optimal Research Standing Operating Procedures.
  • Completing Sponsor-required training prior to study-start.
  • Being prepared for and available at all required company meetings and monitor visits for their assigned protocols at their respective site(s).
  • Assisting in the compilation and organization of all regulatory and administrative binders for their assigned protocols at their respective site(s) upon initial receipt of and wherever applicable.
  • Submitting required administrative paperwork per company timelines.
  • Assisting in addressing and resolving issues from internal/external audits and monitoring letters for all assigned protocols at their respective site(s) in a timely manner.
  • Assists with all other aspects of the study conduct as needed.
  • Any other matters as assigned by management.
  • Willingness to travel up to 50% of the time.

KNOWLEDGE & EXPERIENCE

Education:
  • Bachelor ’s degree preferred
  • High School Diploma or equivalent required
Experience:
  • Biological sample processing, basic laboratory management and training experience
  • 1-2 years of PBMC Technique performance
Credentials:
  • Phlebotomy certification preferred
Knowledge and Skills:
  • Meticulous attention to details and deadlines
  • Knowledge of basic use of scientific methods, procedures, and techniques
  • Good communication skills are required, both written and verbal

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