RN Clinical Research Coordinator

Lightship; Fairfax (VA); On-site; USD 85,000 - 105,000; Full time

Job summary

Lightship is seeking a highly motivated Registered Nurse (RN) Clinical Research Coordinator (CRC) to join our research team. This on-site role requires an active unrestricted RN license in the state of practice, with at least 3 years of clinical research experience and GCP/IATA certification.

You will lead day-to-day trial operations, coordinate visits and data, and ensure regulatory compliance. The CRC will work under the PI and collaborate with sponsors, CROs, IRBs, and vendors to drive study

Qualifications

• Active and unrestricted RN license in the state of practice.
• Graduate of an accredited nursing program; BSN preferred.
• Minimum of 3 years clinical research experience.
• GCP training and IATA/dangerous goods certification.
• Proficiency in phlebotomy and specimen handling.
• Ability to work independently and manage multiple trials.
• Knowledge of ICH E6(R3) and FDA regulations.
• Experience with CTMS/EDC/EHR systems.

Responsibilities

• Coordinate and execute assigned clinical studies from feasibility to close-out.
• Serve as primary site contact for sponsors, CROs, IRBs/IECs, and vendors.
• Manage day-to-day trial operations and communicate with PI.
• Provide nursing procedures within RN scope and protocol.
• Recruit and pre-screen participants; assist informed consent.
• Coordinate participant study visits and follow-up activities.
• Perform phlebotomy and specimen handling as required.
• Maintain complete study records and support audits/regulatory inspections.
• Complete data entry and resolve sponsor or monitor questions.
• Educate participants on study requirements and visits.

Skills

Strong communication

Detail-oriented

Organizational skills

Problem-solving

Education

Bachelor of Science in Nursing

Tools

CTMS

EDC

EHR/eSource

Job description

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 Registered Nurse (RN) Clinical Research Coordinator (CRC) to join our research team. This position requires an active, unrestricted Registered Nurse (RN) license in the state where the employee will perform nursing services, or eligibility to obtain required licensure prior to performing such services. 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, clinical nursing judgment, and the ability to independently manage day-to-day study operations within appropriately trained, qualified, licensed, and delegated responsibilities while supporting appropriate oversight by the Principal Investigator (PI).

Key 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.
• Provide nursing care and perform protocol-required clinical procedures within the RN’s scope of practice, applicable state law, documented training and competency, study protocol, and delegated responsibilities.
• 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 RN scope of practice, 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.
• Perform protocol-required clinical assessments, nursing procedures, and participant monitoring as permitted by applicable law and within documented training, competency, and delegated responsibilities.
• 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 escalation 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.
• Administer study medications or investigational products when permitted by the protocol, applicable law, site requirements, and delegation, and within the RN’s scope of practice and documented competency.
• 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 RN scope of practice, qualifications, training, and delegated responsibilities.

Required Qualifications

• Active and unrestricted Registered Nurse (RN) license in the state in which nursing services will be performed, or eligibility to obtain required licensure prior to performing nursing services.
• Graduate of an accredited nursing program. Bachelor of Science in Nursing (BSN) preferred.
• 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 clinical nursing skills and ability to safely perform protocol-required procedures within the RN’s scope of practice, documented competency, and delegated responsibilities.
• 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.

Preferred Qualifications

• Bachelor of Science in Nursing (BSN).
• 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.

Work Environment & Physical Requirements

• 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.
• Ability to perform nursing and protocol-required clinical procedures consistent with applicable licensure, scope of practice, training, competency, and delegated responsibilities.
• Flexibility to work evenings or weekends as needed to accommodate participant scheduling, protocol-required visit windows, or study timelines.