Study Lab Processor (FOCD-Research)

The Clinical Research Lab Processor will support the research team in conducting clinical trials, working under the direct supervision of the Principal Investigator, Site Manager, and Study Coordinator. He/She will be responsible for the accurate processing, handling, storage, and shipment of biological specimens, ensuring all laboratory activities are performed in compliance with study protocols, Good Clinical Practice (GCP), and DermCare Management Standard Operating Procedures (SOPs). 

 

 

KEY RESPONSIBILITIES: 

Duties will include, but are not limited to: 

• Processing biological specimens (e.g., blood, urine, saliva, tissue samples) in accordance with study protocols, laboratory manuals, and sponsor requirements. 

• Performing centrifugation, aliquoting, labeling, and preparation of samples while ensuring specimen integrity and traceability. 

• Maintaining accurate and complete documentation of specimen handling, including chain of custody logs, temperature logs, and laboratory worksheets in alignment with ALCOA+ principles. 

• Preparing laboratory kits, supplies, and materials for study visits, ensuring readiness and protocol compliance. 

• Monitoring and documenting laboratory equipment and storage conditions, including refrigerators, freezers, and ambient environments; reporting and resolving temperature excursions per SOP. 

• Packaging and shipping specimens to central laboratories or sponsors in compliance with IATA, DOT, and biosafety regulations. 

• Maintaining laboratory inventory and proactively coordinating supply needs to ensure uninterrupted study operations. 

• Assisting with specimen collection and clinical procedures as delegated by the Investigator (including phlebotomy, if certified and within scope). 

• Supporting study start-up, maintenance, and close-out activities related to laboratory processes. 

• Maintaining a clean, organized, and inspection-ready laboratory environment at all times. 

• Assisting with data entry and documentation in source records, CTMS, and EDC systems as authorized. 

• Collaborating with Clinical Research Coordinators and other site staff to ensure efficient study execution. 

• Promoting a team-oriented work environment, prioritizing patient safety, data integrity, and regulatory compliance. 

• Complying with DermCare Management policies, HIPAA, OSHA regulations, GCP guidelines, and applicable SOPs. 

 

 

ESSENTIAL FUNCTIONS: 

• Ability to receive, process, and communicate information verbally and in writing. 

• Ability to work in a fast-paced environment with strict adherence to timelines and protocol requirements. 

• Proficient in accessing, inputting, and retrieving data from electronic systems. 

• Ability to stand or sit for extended periods (6–8 hours) and occasionally lift up to 20 pounds. 

• Manual dexterity required for handling laboratory equipment and performing repetitive tasks. 

• Visual acuity sufficient to accurately label, process, and document specimens.