RN Clinical Research Coordinator

Lightship•Fairfax, VA

18d•Onsite

About The Position

Lightship is seeking a motivated and experienced Registered Nurse Clinical Research Coordinator to coordinate and execute assigned clinical trials at community-based clinics. The role manages study activities from feasibility and start-up through conduct and close-out, in accordance with study protocols, ICH E6(R3) Good Clinical Practice, applicable FDA regulations, IRB/IEC requirements, Lightship SOPs, and site or institutional requirements. The coordinator independently manages day-to-day study operations within appropriately trained, qualified, licensed, and delegated responsibilities, while maintaining communication with and supporting oversight by the Principal Investigator. The role also provides nursing care and performs protocol-required procedures within the RN’s scope of practice, applicable law, documented training and competency, and delegated responsibilities. This is an on-site position and may require evening or weekend work to accommodate participants, visit windows, or study timelines.

Requirements

Active and unrestricted RN license in the state where nursing services will be performed, or eligibility to obtain required licensure before performing those services.
Graduation from an accredited nursing program.
At least 3 years of clinical research experience, preferably in Allergy/Immunology or a related therapeutic area.
Study start-up experience, including IRB/IEC submissions and establishment and maintenance of essential study records and the ISF/eISF.
Current documented 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 shipment preparation.
Clinical nursing skills and ability to safely perform protocol-required procedures within RN scope of practice, documented competency, and delegated responsibilities.
Ability to work independently, prioritize, and manage multiple clinical trials concurrently while maintaining appropriate communication and escalation to the PI and study team.
Working knowledge of ICH E6(R3) GCP, applicable FDA clinical research regulations, informed consent, IRB/IEC requirements, participant privacy and confidentiality, Good Documentation Practices, and clinical research data integrity.
Experience with clinical trial technology and electronic systems, including CTMS, EDC, EHR/eSource, electronic regulatory or eISF platforms, Microsoft Office Suite, and sponsor-provided systems, as applicable.
Strong written and verbal communication, organizational, attention-to-detail, time-management, and problem-solving skills.

Nice To Haves

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 EHR, eSource, electronic regulatory, and other clinical research technology platforms.

Responsibilities

Coordinate assigned clinical research studies from feasibility and study start-up through study conduct and close-out, including regulatory activities, recruitment, study visits, data collection, follow-up, and close-out.
Serve as a primary site contact for sponsors, CROs, IRBs/IECs, and study vendors, as appropriate; coordinate delegated regulatory submissions and study-related submissions.
Manage day-to-day trial operations within assigned and delegated responsibilities, communicating 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 law, documented training and competency, and delegated responsibilities.
Recruit and pre-screen potential participants, conduct protocol-specific screening, support informed consent, obtain consent when appropriately trained and delegated, and coordinate enrollment.
Coordinate participant study visits, retention, and follow-up.
Perform and document phlebotomy, venipuncture, specimen collection, processing, storage, and shipment in accordance with applicable procedures and shipping requirements.
Maintain complete, accurate, and inspection-ready study records, including the ISF/eISF, training and delegation records, source documents, EHR/eSource records, CRFs, EDC records, and other required documentation.
Enter and review study data accurately and promptly, and facilitate resolution of data queries, discrepancies, missing information, and sponsor or monitor requests.
Identify, document, and promptly escalate adverse events, serious adverse events, protocol deviations, and other significant issues; support safety and regulatory reporting within delegated responsibilities.
Prepare for and support site qualification, initiation, monitoring, close-out, audits, and regulatory inspections; facilitate resolution of findings and action items.
Perform delegated investigational product activities, as applicable, including receipt, storage, temperature monitoring, accountability, dispensing support, returns, and coordination with pharmacies or responsible personnel.
Administer study medications or investigational products when permitted by the protocol, applicable law, site requirements, delegation, and the RN’s scope and competency.
Educate participants about study requirements, study medications or investigational product instructions, visit schedules, procedures, responsibilities, and study-related contacts.
Protect participant privacy and confidentiality and handle records in accordance with applicable requirements and Lightship policies.
Manage study supplies, laboratory kits, specimen materials, and shipping supplies, including inventory and expiration-date tracking, as applicable.
Track recruitment, screening, enrollment, and retention; communicate study status, operational risks, barriers, and escalations to the PI and appropriate stakeholders.
Complete required protocol, sponsor, system, SOP, and study-specific training on time and maintain required training and competency documentation.
Perform other assigned responsibilities consistent with the individual’s RN scope of practice, qualifications, training, and delegated responsibilities.