Clinical Research Coordinator Phlebotomy Trained

Clinical Research Coordinator Phlebotomy Trained

Lightship is a clinical trial site organization delivering on-site, hybrid, and virtual trials through a single, trusted partner. Our expanded reach model places each visit in the most practical setting, increasing access, strengthening enrollment and engagement, and improving representation across diverse communities.

Our investigators and study teams follow participants across all visit types, supported by a unified SOP framework and shared technology backbone. This continuity preserves oversight, streamlines study conduct, and gives sponsors auditable visibility across the entire participant journey.

With a growing footprint of eight physical sites and mobile research units (MRUs) that extend site capabilities into the community, Lightship increases access for participants who might otherwise be out of reach. Our 96 percent retention rate, 30-plus sponsor audits, and multiple FDA engagements reflect a strong quality record that gives sponsors confidence in a reliable path to high-performing trial execution.

We’re building trial experiences that reflect real life: expanding reach, reducing burden, and bringing better therapies to market faster.

Lightship aims to bring life-changing treatments to more patients in need by supporting community-based clinics with clinical research resources.

We are seeking a highly motivated and experienced Clinical Research Coordinator (CRC) to join our research team. The CRC will be responsible for the day-to-day coordination and execution of assigned clinical trials in accordance with study protocols, Good Clinical Practice (ICH E6(R3)), applicable FDA regulations, IRB/IEC requirements, Lightship Standard Operating Procedures (SOPs), and applicable site or institutional requirements.

This position requires initiative, professionalism, strong organizational skills, and the ability to independently manage day-to-day study operations within appropriately trained, qualified, and delegated responsibilities while supporting appropriate oversight by the Principal Investigator (PI).

• Coordinate and execute assigned clinical research studies from feasibility and study start-up through study conduct and close-out, including site feasibility support, regulatory activities, participant recruitment, study visits, data collection, follow-up, and close-out activities.
• Serve as a primary site contact for sponsors, Contract Research Organizations (CROs), IRBs/IECs, and study vendors, as appropriate. Coordinate and manage regulatory submissions, amendments, continuing reviews, responses to queries, and other study-related submissions within delegated responsibilities.
• Independently manage day-to-day clinical trial operations within assigned and delegated responsibilities while maintaining appropriate communication with and supporting oversight by the Principal Investigator.
• Recruit and pre-screen potential participants; perform protocol-specific screening activities; support the informed consent process; obtain informed consent when appropriately trained, delegated, and permitted; and coordinate participant enrollment in accordance with the protocol, IRB-approved documents, and applicable requirements.
• Coordinate participant study visits, retention, and follow-up activities. Perform protocol-required study procedures within the CRC’s documented training, qualifications, and delegated responsibilities.
• Perform and document phlebotomy, venipuncture, specimen collection, processing, storage, and shipment activities in accordance with the protocol, laboratory manual, applicable SOPs, and IATA/dangerous goods shipping requirements.
• Maintain complete, accurate, and inspection-ready essential study records, including the Investigator Site File (ISF/eISF), delegation and training documentation, source documents, eSource/EHR records, case report forms (CRFs), electronic data capture (EDC) systems, and other required study documentation in accordance with Good Documentation Practices and data integrity requirements.
• Complete accurate and timely study data entry and review and facilitate timely resolution of data queries, discrepancies, missing information, and sponsor/monitor requests.
• Identify, document, and promptly escalated adverse events (AEs), serious adverse events (SAEs), protocol deviations, and other significant study issues to the Principal Investigator and appropriate study personnel. Support required safety and regulatory…