| Job Description: |
Clinical Trial Sample Processing and Sample Management
Under general supervision:
- Perform human clinical trial biospecimen processing, including peripheral blood mononuclear cell (PBMC) isolation, processing, and cryopreservation, serum processing, CTC processing and tissue banking for all clinical biopsies from patients.
- Process, label, store, and bank clinical research samples according to study protocols and laboratory procedures.
- Maintain accurate electronic and paper records related to sample collection, processing, storage, and shipment.
- Assits with Organizing and tracking clinical specimens to ensure proper chain of custody and sample integrity.
- Assist with maintaining clinical trial documentation and study records.
- Monitor inventory levels and help order supplies required for clinical sample processing activities.
- Follow established SOPs and assist with SOP updates as directed
Clinical Immune Monitoring and Research Support
- Assist with clinical immune-monitoring studies using patient-derived samples.
- Help Prepare and stain samples for flow cytometry analysis.
- Operate laboratory instrumentation, including flow cytometers and related equipment, following established protocols.
- Help with the Processing of patient PBMCs for downstream applications, including singlecell RNA sequencing and bulk RNA analysis.
- Perform RNA extraction and other molecular biology procedures according to established methods.
- Assist with confocal microscopy experiments and routine laboratory assays.
- Record experimental results and maintain laboratory notebooks and electronic data files.
- Update Electronic Teams notebooks and onedrive files with the raw and processed/graphed data results
- For the Research and Development Manager.
- Assist in data compilation, quality control reviews, and preparation of research reports and
presentations.
Laboratory Operations and Compliance
- Prepare laboratory reagents, buffers, and materials for research clincal immune monitoring activities.
- Maintain inventory of all supplies for assays related to immune monitoring as well as records and stock laboratory supplies.
- Ensure laboratory workspaces remain organized and compliant with laboratory safety standards.
- Participate in biosafety, chemical safety, and regulatory compliance activities.
- Assist with maintaining laboratory clinical batch records and documentation required for
- inspections and and FDA/NIH audits.
- Maintain the clincal trial notebooks and the electronic teams folders for all clinical processing of
- Samples and keep all records, images and locations of clinical samples up to date weekly.
- Maintain the electronic spreasheets of Clincial patient samples, organized by sample type, (PBMC, Serum,
- Cell free DNA/RNA, CTC and tissue Biopsies) make sure all sampels are recorded and logged at intake during processing and when removed for immune monitoring assays.
Training and Professional Development
- Attend laboratory meetings, seminars, and training sessions.
- Participate in continuing education opportunities to maintain technical competency.
- Assist with training new laboratory personnel on routine laboratory procedures as directed.
Administrative and Departmental Support
- Provide support for laboratory inspections, audits, and accreditation activities.
- Assist with preparation of routine laboratory reports, meeting materials, and other administrative
- documents.
- Participate in departmental activities and collaborative projects as assigned.
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