Clinical Research Associate

Position Summary

The Research Associate supports daily operations in our CLIA/CAP-regulated clinical diagnostics laboratory. Responsibilities span hands-on wet-lab work (cell culture and assay support), clinical sample accessioning, chain-of-custody activities and customer-facing coordination. The role requires strong technical competence, meticulous documentation, and a service-oriented approach to maintain compliance, turnaround time, and quality.

Key Responsibilities

Clinical Laboratory Operations (CLIA/CAP)

• Perform laboratory activities in accordance with CLIA, CAP, and laboratory SOPs, including documentation, data integrity, and change-control requirements.
• Maintain accurate records in LIMS/ELN systems for samples, reagents, QC/QA activities, and test-related documentation.
• Support internal audits, corrective and preventive actions (CAPA), and continuous improvement initiatives as assigned.
• Assist with equipment maintenance, calibration verification, inventory control, and reagent lot tracking.

Cell Culture and Assay Support

• Perform routine mammalian cell culture (primary cells and/or established cell lines), including thawing, passaging, counting, viability assessment, and cryopreservation.
• Prepare media, buffers, and reagents; maintain aseptic technique and follow biosafety procedures.
• Support clinical diagnostic assays through sample preparation, plating, labeling, QC checks, and basic data review (per training and authorization).
• Document deviations, troubleshoot basic workflow issues, and escalate technical concerns to senior staff as appropriate.

Clinical Sample Accessioning and Chain of Custody

• Receive, inspect, and accession clinical specimens per SOPs, test requisitions, and acceptance criteria.
• Verify identifiers, requisitions, specimen integrity, and shipping/temperature conditions; resolve discrepancies while maintaining compliance.
• Label, aliquot, store, and route samples to appropriate workflow stages with strict chain-of-custody and temperature control.
• Coordinate sample shipments and returns as needed, including packaging and documentation consistent with applicable regulations.

Customer Service and Client Coordination

• Serve as a point of contact for specimen status updates, kit logistics, requisition questions, and general support inquiries.
• Communicate professionally with clinicians, clinical sites, and internal stakeholders to resolve sample issues and support turnaround time commitments.
• Track inquiries and resolutions to ensure timely follow-up and clear documentation.

Required Qualifications

• Bachelor’s degree in Biology, Biochemistry, Molecular Biology, Biomedical Engineering, or a related life-science field (or equivalent practical experience).
• 1 to 3+ years of relevant experience in a clinical diagnostics, regulated laboratory, or comparable environment.
• Demonstrated hands-on experience with mammalian cell culture and aseptic technique.
• Experience accessioning clinical specimens and maintaining chain-of-custody documentation; LIMS experience strongly preferred.
• Strong customer service skills with the ability to communicate clearly and professionally with external clients.
• Prior experience working in a CLIA and/or CAP-accredited laboratory environment is highly desirable.
• Familiarity with quality systems (SOPs, deviations, CAPA, internal audits, document control, inventory management).
• Experience with barcode-based sample tracking and regulated data systems (LIMS/ELN).
• Knowledge of biosafety requirements (BSL-2), clinical specimen handling, and relevant shipping regulations. Core Competencies
• High attention to detail, strong organizational skills, and consistent documentation habits.
• Ability to manage multiple priorities in a deadline-driven environment while maintaining quality standards.
• Service orientation: responsive, solutions-focused communication with clients and internal teams.
• Integrity and accountability in handling clinical specimens and patient-related data.
• Team collaboration with the ability to work independently when needed.

Work Environment and Physical Requirements

• Laboratory-based role requiring adherence to PPE and biosafety procedures (typically BSL-2).
• Ability to stand for extended periods; perform repetitive pipetting; lift and move materials up to approximately 25 lbs.
• May require occasional schedule flexibility to support sample receipt timelines and operational needs.

Pay

· $32 - $35 per hour

· $32 - $35 per hour