Clinical Research Coordinator Phlebotomy Trained

Lightship is a clinical trial site organization supporting on-site, hybrid, and virtual clinical trials through community-based clinics and mobile research units. The Clinical Research Coordinator will coordinate and execute assigned clinical trials from study start-up through close-out, including participant recruitment, study visits, phlebotomy, specimen handling, regulatory activities, data management, and compliance support.

Responsibilities

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 escalate 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 reporting within delegated responsibilities

Prepare for, coordinate, and support site qualification/pre-study visits, site initiation visits, interim monitoring visits, close-out visits, sponsor or quality audits, and regulatory inspections. Track and facilitate timely resolution of monitoring findings, audit observations, and action items

Perform delegated investigational product activities, as applicable, including receipt, storage, temperature monitoring, accountability, reconciliation, dispensing support, returns, and coordination with clinical pharmacies or other responsible personnel

Educate participants regarding study requirements, study medications or investigational product instructions as appropriate, visit schedules, study procedures, participant responsibilities, and whom to contact with study-related questions or concerns

Protect participant privacy and confidentiality and handle clinical research records and information in accordance with applicable privacy requirements, study requirements, and Lightship policies

Manage study supplies, laboratory kits, specimen materials, shipping supplies, and other study-specific materials, including inventory and expiration-date tracking, as applicable

Track study recruitment, screening, enrollment, and retention activities and communicate study status, operational risks, barriers, and required escalations to the PI and appropriate study stakeholders

Complete required protocol, sponsor, system, SOP, and study-specific training within established timelines and maintain documentation of training and competency as required

Perform other responsibilities as applicable and assigned within the individual’s qualifications, training, and delegated responsibilities

Preferred

Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or equivalent clinical research credential

Experience with Phase I–IV industry-sponsored clinical trials

Previous clinical research experience in Allergy/Immunology

Familiarity with electronic health record (EHR), eSource, electronic regulatory, and other clinical research technology platforms

Certified Clinical Research Coordinator

Certified Clinical Research Professional

Phase I–IV clinical trials

Allergy/Immunology experience

Electronic health record

eSource

Electronic regulatory

Clinical research technology

Company

Clinical trial site network for on-site, hybrid, and virtual trials

Durham, North Carolina, USA

https://www.lightship.com/

Founded in 2018

51-200 employees

Qualifications

Bachelor's degree in life sciences, nursing, healthcare, or a related field, or equivalent relevant clinical and/or clinical research experience

Minimum of 3 years of clinical research experience, preferably within Allergy/Immunology or a related therapeutic area

Demonstrated study start-up experience, including IRB/IEC submissions and establishment and maintenance of essential study records and the Investigator Site File (ISF/eISF)

Current documented Good Clinical Practice (GCP) training and current IATA/dangerous goods shipping training or certification, as applicable to assigned responsibilities

Proficiency in phlebotomy and venipuncture, including specimen collection, processing, storage, and preparation for shipment

Demonstrated ability to work independently, prioritize responsibilities, and manage multiple clinical trials concurrently while maintaining appropriate communication and escalation to the Principal Investigator and study team

Working knowledge of ICH E6(R3) Good Clinical Practice, applicable FDA clinical research regulations, informed consent requirements, IRB/IEC requirements, participant privacy and confidentiality, Good Documentation Practices, and clinical research data integrity expectations

Experience with clinical trial technology and electronic systems, including CTMS, EDC, EHR/eSource, electronic regulatory or eISF platforms, Microsoft Office Suite, and sponsor-provided study systems, as applicable

Strong written and verbal communication, organizational, attention-to-detail, time-management, and problem-solving skills

This is an on-site position and may require prolonged sitting, standing, or walking

Ability to lift up to 25 lbs., including laboratory supplies, study materials, or shipping containers

Ability to perform phlebotomy and specimen-processing activities safely and in accordance with applicable procedures

Flexibility to work evenings or weekends as needed to accommodate participant scheduling, protocol-required visit windows, or study timelines

Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or equivalent clinical research credential

Experience with Phase I–IV industry-sponsored clinical trials

Previous clinical research experience in Allergy/Immunology

Familiarity with electronic health record (EHR), eSource, electronic regulatory, and other clinical research technology platforms

Minimum of 3 years of clinical research experience, preferably within Allergy/Immunology or a related therapeutic area.

Required skills

Clinical Research, Clinical Trial Study Start-Up, IRB/IEC Regulatory Submissions, Clinical Practice (ICH E6(R3)), FDA Clinical Research Regulations, Phlebotomy and Venipuncture, Specimen Collection and Processing, IATA/Dangerous Goods Shipping, Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), Electronic Health Records and eSource, Electronic Investigator Site Files (eISF)

Preferred skills

Previous clinical research experience in Allergy/Immunology, Durham, North Carolina, USA, https://www.lightship.com, Growth Stage, Total Funding, $76.51M, Key Investors, Brook Byers,Define Ventures, McKesson Ventures, 2024-02-12, Series C· $16.51M, 2021-10-06, Series B· $40M, 2020-02-03, Series A· $20M, Leadership Team, Lesley Solomon, Operating Partner, AI & Clinical Strategy, Recent News, Prelude Ventures, 2026-07-09, BioSpace, 2026-02-04, Circuit Clinical, 2025-06-09, Company data provided by, AI Tools, Customize Your Resume, Maximize your interview chances, Build Cover Letter

Experience

3+ years