Clinical Research Coordinator, RN

Lightship is a clinical research company improving how trials are delivered through a hybrid model, broad clinical capabilities, and in-house participant care services. The Clinical Research Coordinator, RN manages clinical research studies and provides protocol-required care at an assigned Lightship partner clinic. This role requires a dependable, self-directed professional who can manage competing priorities independently. The position is primarily in-person at an assigned partner clinic, with travel to support activities within mobile units, participant homes, or other locations as needed. Key Responsibilities Maintain a thorough working knowledge of each study protocol Support study start-up and close-out activities, including regulatory document finalization, site activation readiness, and document archiving Identify, recruit, (pre)screen, and enroll eligible participants Conduct or support the informed consent process as needed Schedule & coordinate study visits and assessments within protocol-required windows Preparation and submission of regulatory documents to the IRB. Establish and maintain the paper or electronic regulatory binder Maintain and update delegation of authority logs; ensure study staff are appropriately trained and documented Identify, document, and report protocol deviations Serve as a primary point of contact for sponsors, CRAs, participants, investigators, and study staff Support SIVs, monitoring visits, and internal/external audits as requested Create and maintain source documentation to ALCOA-C standards Enter study data into EDC systems and resolve data queries Perform protocol-required clinical procedures and assessments, including, but not limited to, IMP management and administration, venipuncture, IV management, vital signs collection, biospecimen collection and processing, and conducting ECGs Prepare and ship ambient, refrigerated, and frozen biospecimen samples, including handling dry ice when needed Coordinate with central labs, imaging vendors, and other study vendors to ensure protocol compliance and timely data/sample handling Dispense or administer investigational medications and educate participants on self-administration Maintain investigational product accountability Identify, document, and report adverse events and serious adverse events Educate participants on study procedures, answer questions with sensitivity, and appropriately escalate issues when needed Maintain stock of study supplies, materials, and equipment Perform routine quality control checks of source documentation, regulatory files, and data entry to ensure accuracy and compliance Complete and maintain required protocol, GCP, and system trainings in accordance with sponsor and organizational requirements Manage business-related expenses and associated report submissions Perform other duties as assigned Skills and Competencies Strong adult venipuncture skills required; adult and pediatric preferred Proficiency processing, centrifuging, and aliquoting biospecimens within a clinical research setting Working knowledge of Good Clinical Practice and the federal regulations governing clinical research Proficiency with electronic data capture systems and source documentation standards Knowledge of medical terminology, drug calculations, and general clinical medicine Ability to manage competing study timelines and priorities independently Strong verbal and written communication skills, including timely maintenance of email and internal messages Ability to build positive continuous relationships with participants, caregivers, and families Ability to remain calm and professional when working with participants, physicians, and research staff Education, Licensure, and Certification ADN required; BSN preferred Current Basic Life Support (BLS) certification preferred Current Category B Biological Substances shipping certification preferred At least two years of CRC experience for sponsor-funded interventional clinical trials required At least one year of non-research bedside nursing experience required; two years preferred. Additional Requirements Physical ability to perform nursing duties and lift equipment weighing up to 15 kg Valid driver's license and consistent access to reliable transportation Ability to book and manage travel accommodations as needed with corporate card Willingness to maintain clinical compliance and submit all required health documentation on time. Lightship requires titer-demonstrated immunity from the following infectious diseases within the first 30 days of hire: Measles, Mumps, Rubella, Hepatitis-B, and Varicella. Proof of unexpired vaccination is required within 30 days of hire for Tetanus/Diphtheria/Pertussis (Tdap), COVID-19, and Seasonal Influenza #J-18808-Ljbffr Lightship