Phlebotomist / Clinical Research Assistant

The primary responsibility of this role is to serve as the primary phlebotomist for participant visits, providing skilled venipuncture and capillary collection, a high-quality participant experience, and accurate specimen collection documentation. Secondarily, you will work closely with the Clinical Research Coordinator (CRC) and support delegated Clinical Research Coordinator responsibilities, including participant scheduling, visit preparation, study documentation, data entry, and maintenance of study logs. You will also occasionally provide laboratory support, including specimen preparation, processing, handling, and testing activities performed within documented training and authorization.

What You Will Do

Phlebotomy & Participant Support (70%)

• Perform venipuncture and capillary collection for adult donors using approved straight needles, butterflies, and finger-stick collection techniques, as applicable.
• Confirm donor identity and collection requirements; prepare, select, label, and verify collection tubes and materials accurately.
• Provide professional, courteous, and reassuring participant care before, during, and after blood collection.
• Monitor donors for collection-related reactions or adverse events, follow established response procedures, complete required documentation, and promptly escalate concerns.
• Prepare and maintain clean, safe blood collection areas, including decontamination, infection-control practices, sharps disposal, and biohazardous waste management.
• Maintain phlebotomy room readiness by ordering supplies, organizing materials, monitoring inventory, and tracking expiration dates.
• Maintain accurate and contemporaneous blood collection and specimen records in electronic and/or written systems.
• Comply with HIPAA confidentiality requirements and all applicable company safety procedures.

Clinical Research Support (20%)

• Work closely with the CRC to support donor recruitment, pre-screening, scheduling, re-scheduling, appointment reminders, and visit preparation.
• Assist with informed consent logistics and documentation.
• Participate in or conduct consent activities only when appropriately trained, delegated, and permitted by the protocol, IRB requirements, and company procedures.
• Complete delegated participant-facing study procedures, source documentation, questionnaires, and data entry accurately and contemporaneously.
• Maintain up-to-date study documentation, including enrollment, visit, specimen tracking, collection, eligibility/screening, and compensation logs, as applicable.
• Prepare study and participant materials, assemble visit packets, maintain organized subject records, and file approved documents in designated study repositories.
• Coordinate specimen handoffs and communicate donor status, cancellations, schedule changes, and sample availability to the CRC and laboratory stakeholders.
• Identify missing, inconsistent, or potentially noncompliant information and route it to the CRC for review and resolution.
• Support study training, meetings, process improvements, and other clinical operations activities as assigned.

Laboratory & Specimen Support (10%)

• Prepare collected specimens for testing and analysis, including labeling, centrifugation, aliquoting, processing, staging, storage, and distribution, as assigned.
• Confirm specimen identity, integrity, tube type, volume, collection time, and required documentation before testing or laboratory handoff.
• Load samples onto approved laboratory analyzers and perform assigned procedures within documented training, authorization, and supervision requirements.
• Work in the laboratory with Research Associates to support studies on Truvian and other clinical laboratory instrumentation, as needed.
• Maintain specimen traceability and promptly escalate labeling discrepancies, insufficient or compromised specimens, processing errors, or deviations.
• Observe all laboratory safety precautions, including required personal protective equipment, sanitation, decontamination, and waste-disposal procedures.

What You Will Bring

• A high school diploma or equivalent.
• A current California state Certified Phlebotomy Technician certificate (CPT I or CPT II).
• A minimum of 2 years of hands-on phlebotomy experience performing venipuncture and capillary collection for adult donors in a fast-paced environment. Additional experience is strongly preferred.
• Experience preparing, processing, labeling, handling, and maintaining traceability of blood specimens in a clinical, research, or laboratory environment.
• Clinical research support experience, including participant scheduling, study visits, source documentation, data entry, informed consent support, or study-log maintenance, preferred.
• Working knowledge of GCP, human subject protection, HIPAA, and clinical research documentation principles applicable to IVD/device clinical studies, preferred.
• Ability to work as a collaborative clinical research team member with positive, timely written and verbal communication, including communicating collection concerns, documentation discrepancies, deviations, or study execution issues.
• Strong organizational and time-management skills, with the ability to manage changing priorities and maintain accuracy and completeness in participant, specimen, and study documentation.
• Experience with business and study-management tools, including Microsoft Office products and Smartsheet or similar project-tracking tools.
• A solution-oriented, problem-solving approach and the ability to thrive in a fast-paced start-up environment.
• Flexibility to accommodate study-driven scheduling needs, which may include occasional early, late, overtime, or (on rare occasions) weekend hours.