Study Lab Processor

Study Lab Processor The Study Lab Processor supports the research team in the conduct of clinical trials under the direct supervision of the Principal Investigator and Site Director. The Study Lab Processor is responsible for the accurate processing, handling, storage, and shipment of biological specimens and for ensuring that laboratory activities are performed in compliance with study protocols, laboratory manuals, sponsor requirements, Good Clinical Practice (GCP), Derm.

Care Management Standard Operating Procedures (SOPs), and applicable regulatory requirements.

Key Responsibilities

Process biological specimens, including blood, urine, saliva, and tissue samples, in accordance with study protocols, laboratory manuals, and sponsor requirements. Perform centrifugation, aliquoting, labeling, and preparation of samples while ensuring specimen integrity and traceability. Maintain accurate and complete documentation of specimen handling, including chain-of-custody logs, temperature logs, and laboratory worksheets, in alignment with ALCOA+ principles.

Prepare laboratory kits, supplies, and materials for study visits, ensuring readiness and protocol compliance. Monitor and document laboratory equipment and storage conditions, including refrigerators, freezers, and ambient environments. Report and resolve temperature excursions in accordance with SOPs. Package and ship specimens to central laboratories or sponsors in compliance with IATA, DOT, and applicable biosafety regulations.

Maintain laboratory inventory and proactively coordinate supply needs to ensure uninterrupted study operations. Assist with specimen collection and clinical procedures as delegated by the Investigator, including phlebotomy when certified and within scope. Support study start-up, maintenance, and close-out activities related to laboratory processes.

Maintain a clean, organized, and inspection-ready laboratory environment at all times. Assist with data entry and documentation in source records, CTMS, and EDC systems as authorized. Collaborate with Clinical Research Coordinators and other site staff to ensure efficient study execution. Promote a team-oriented work environment while prioritizing patient safety, data integrity, and regulatory compliance.

Comply with Derm. Care Management policies, HIPAA requirements, OSHA regulations, GCP guidelines, applicable SOPs, and other relevant regulatory requirements.

Essential Functions

Ability to receive, process, and communicate information effectively, both verbally and in writing. Ability to work in a fast-paced environment while strictly adhering to study timelines and protocol requirements. Proficiency in accessing, entering, and retrieving data from electronic systems. Ability to stand or sit for extended periods, approximately 6–8 hours and occasionally lift up to 20 pounds.

Manual dexterity sufficient to handle laboratory equipment and perform repetitive laboratory tasks. Visual acuity sufficient to accurately label, process, and document specimens. This position operates in a professional office environment. The role regularly requires standing, sitting, working at a computer, communicating with employees and managers.

There are no regular lifting requirements beyond standard office/ practice materials. The work environment is typical of an office/ practice setting. This job description is intended to provide a general overview of the position and does not encompass all tasks or responsibilities that may be required. The duties and requirements of this role may be subject to change and additional duties may be assigned as needed.