Clinical Study Sample Processor I

at  Prometheus Laboratories Inc

SUMMARY

Responsible for Saturday receipt and handling of commercial laboratory specimen for commercial testing. Responsible for Tuesday-Friday receipt, handling and processing of clinical study samples received by our Corporate Biobank. This can be for single or batch shipments as part of; company sponsored clinical studies, research collaborations, or pharma partners’ clinical studies. In addition, supports sample request activities for clinical study samples (e.g. pull aliquots from our controlled inventory, prepping aliquots for CLIA testing).

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following: Other duties as assigned.

• Management of daily receipt, handling and storage of prospective (single) clinical study samples (either company sponsored, collaborations, or pharma studies), including the archiving of the associated documents, and data entry into the LIMS system for e-tracking.
• Receipt, handling and storage of periodic retrospective (batch) sample shipments from clinical studies (either company sponsored, collaborations, or pharma studies), including verification of vial information against E-manifest, labeling of vials, and filing of paperwork.
• Prepare aliquots for testing in commercial (LIMS readiness), or research laboratories, this might include, but is not limited to create/transfer aliquots containing whole blood, serum, plasma, PBMC, tissue and feces.
• Insure that “chain-of-custody” for all corporate biobank procured samples is maintained upon receipt (GCP).
• De-identify samples received with protective health information (PHI) or those that can be linked to personal identifiable information (PII).
• Generate aliquot inventory of legacy cohorts identified while; using a specific software template, working on dry ice, and limit frequency of freezer access while keeping the specimen frozen at all times.
• Quarantine unknown shipments and those shipments not associated with an executed legal agreement
• Use handheld and plate barcode scanners and associated software.
• Receipt of shipments with visible biohazardous material on outside of the shipper, including the proper handling and disposal of such shipment.
• Responds to freezer alarms and coordinate transfer of contents as required
• Coordinates PM and refrigerator/freezer cleaning with Metrology
• Accession commercial test orders (on Saturday)
• Responsible for initiating Corporate Biobank deviations for sample & shipment conditions deviating for the standard operating procedures.
• Work closely with Corporate Biobank Manager to manage existing inventory, including but not limited to creating inventory of legacy collections, review available capacity for efficient use of storage space, and prepare freezers for Metrology for PM and temperate (re-)validations activities.
• Maintaining an accurate inventory in LIMS system of physical inventory in stand-alone controlled freezers.
• Present during laboratory operating working hours: Tuesday – Saturday
• Required to follow all safety procedures, policies and precautions.
• Must be an excellent team player, communicator and proactive in addressing upcoming issues regarding time lines, workload, or any other workflow related issues.

QUALIFICATIONS

An individual must be able to perform the essential duties satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Position generally requires a high school diploma or general education degree (GED) and 2+ years related experience. Preferred is a Bachelors degree. Must have the ability to work in a team structure and to plan, organize and prioritize work. Data entry experience strongly preferred. Experience working in a CLIA/CAP, GCP or GMP/FDA regulated environment preferred. Eye for detail and comfort with different software systems is critical (e.g. Excel, Access, Word, VisionMate), where experience working with a LIMS (StarLIMS, LabVantage) is preferred. Ability to effectively recognize and comfortably switch between (standard operating) procedures on a daily basis. Ability to effectively follow instructions of multiple standard operating procedures on different laboratory workflows is required. Strong laboratory skills (including use of pipets, centrifuges and barcode scanners) and communication skills are required. Working knowledge of clinical science, translational medicine, and/or genetic testing is beneficial.

LANGUAGE SKILLS

Ability to read and comply with all applicable laboratory regulated guidelines. Ability to write reports, and procedure manuals. Ability to effectively work cross functionally and build strong working relationships with others.

MATHEMATICAL SKILLS

Ability to work with mathematical concepts up to probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to use Excel to match values.

• Management of daily receipt, handling and storage of prospective (single) clinical study samples (either company sponsored, collaborations, or pharma studies), including the archiving of the associated documents, and data entry into the LIMS system for e-tracking.
• Receipt, handling and storage of periodic retrospective (batch) sample shipments from clinical studies (either company sponsored, collaborations, or pharma studies), including verification of vial information against E-manifest, labeling of vials, and filing of paperwork.
• Prepare aliquots for testing in commercial (LIMS readiness), or research laboratories, this might include, but is not limited to create/transfer aliquots containing whole blood, serum, plasma, PBMC, tissue and feces.
• Insure that “chain-of-custody” for all corporate biobank procured samples is maintained upon receipt (GCP).
• De-identify samples received with protective health information (PHI) or those that can be linked to personal identifiable information (PII).
• Generate aliquot inventory of legacy cohorts identified while; using a specific software template, working on dry ice, and limit frequency of freezer access while keeping the specimen frozen at all times.
• Quarantine unknown shipments and those shipments not associated with an executed legal agreement
• Use handheld and plate barcode scanners and associated software.
• Receipt of shipments with visible biohazardous material on outside of the shipper, including the proper handling and disposal of such shipment.
• Responds to freezer alarms and coordinate transfer of contents as required
• Coordinates PM and refrigerator/freezer cleaning with Metrology
• Accession commercial test orders (on Saturday)
• Responsible for initiating Corporate Biobank deviations for sample & shipment conditions deviating for the standard operating procedures.
• Work closely with Corporate Biobank Manager to manage existing inventory, including but not limited to creating inventory of legacy collections, review available capacity for efficient use of storage space, and prepare freezers for Metrology for PM and temperate (re-)validations activities.
• Maintaining an accurate inventory in LIMS system of physical inventory in stand-alone controlled freezers.
• Present during laboratory operating working hours: Tuesday – Saturday
• Required to follow all safety procedures, policies and precautions.
• Must be an excellent team player, communicator and proactive in addressing upcoming issues regarding time lines, workload, or any other workflow related issues