Clinical Research Coordinator

Position Summary 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). 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. 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 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. 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. Required 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. Preferred Qualifications 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. Flexibility to work evenings or weekends as needed to accommodate participant scheduling, protocol-required visit windows, or study timelines. #J-18808-Ljbffr