Clinical Research Coordinator (Contractor, Onsite)
19 hours ago
Oviedo
RapidTrials is seeking an experienced Clinical Research Coordinator to provide immediate onsite support for a pediatric rare disease clinical trial at a research site in Spain. The primary near-term focus of this role is to help the site begin and accelerate patient pre-screening and screening activities. Todos los posibles candidatos deben leer con atención los siguientes detalles de este trabajo antes de presentar una candidatura. The contractor will work under the direction and delegation of the Principal Investigator (PI) and designated site study team. Responsibilities may include medical record review, identification of potentially eligible participants, screening coordination, study documentation, data entry, participant and family communication, and coordination of protocol-required assessments. Final eligibility decisions, medical judgment, informed consent oversight, and other investigator responsibilities remain with the PI and appropriately delegated site personnel. Type of Position: Contract, Onsite Study: Pediatric Rare Disease Clinical Trial Schedule: Immediate support required; onsite schedule to be coordinated with the site based on screening needs Start Date: late July, early August Urgent, time-sensitive assignment; Reports to: Principal Investigator (PI), site study team lead, or designee Travel or Out-of-pocket Expenses: Not reimbursed unless pre-approved in writing ESSENTIAL JOB FUNCTIONS: • Conduct protocol-specific pre-screening using medical records, referral information, eligibility checklists, and tracking tools., • Review available records for diagnosis, genetic confirmation, growth history, prior and current human growth hormone treatment, anthropometric data, medical history, concomitant medications, and other protocol-relevant factors., • Identify potentially eligible participants and promptly elevate uncertain eligibility questions to the PI or appropriately delegated clinician., • Coordinate screening visits, participant and parent or guardian communications, appointment scheduling, and collection of required historical documentation., • Support the informed consent and assent process as delegated, including preparation of approved materials and documentation of the process. The PI or qualified designee retains responsibility for consent oversight and medical discussions., • Coordinate protocol-required screening assessments, laboratory procedures, measurements, imaging, and specialty evaluations with site departments and external vendors, as applicable., • Enter and maintain accurate, timely data in the electronic data capture system and resolve data queries in collaboration with the investigator and study team., • Maintain screening, enrollment, delegation, training, visit, and other study logs in accordance with site and sponsor requirements., • Support source documentation, filing, essential document maintenance, and preparation for monitoring visits, audits, and inspections., • Communicate screening progress, including completion of prescreening logs (as required by the Sponosr) barriers, potential participants, missing documentation, and operational risks to the PI, site team, CRA, and other authorized study contacts., • Protect participant confidentiality and process personal and health information only through approved site systems and workflows., • Complete all required protocol, investigational product, systems, GCP, privacy, safety, and site onboarding training before performing delegated study activities., • Perform additional study coordination duties assigned by the PI or designee within the contractor’s documented delegation, training, qualifications, and scope of practice.SKILLS & ABILITIES:, • Proficiency with clinical trial pre-screening, screening coordination, source documentation, EDC data entry, query resolution, and study tracking logs., • Ability to review complex pediatric medical records and interpret protocol-level eligibility criteria while recognizing when medical judgment must be escalated to an investigator., • Familiarity with rare disease, pediatric, endocrinology, growth disorder, or genetics research is strongly preferred., • Understanding of participant and family-centered communication, including the sensitivities of pediatric studies and interactions with parents or legal guardians., • Ability to collaborate effectively with investigators, nurses, coordinators, hospital departments, CRAs, central laboratories, and sponsor or CRO representatives., • Proficiency with Microsoft Office, electronic medical records, EDC platforms, secure document systems, and clinical trial management tools., • Professional fluency in Spanish is required. Working proficiency in English is strongly preferred for protocol, system, and sponsor communications.EXPERIENCE AND EDUCATION:, • Minimum of 3 years of experience as a Clinical Research Coordinator, Research Nurse, Study Coordinator, or similar site-based clinical research professional supporting industry-sponsored interventional trials., • Experience with participant pre-screening, screening, enrollment, visit coordination, EDC, source documentation, and monitoring visit support required., • Pediatric, endocrinology, rare disease, growth disorder, genetic, or metabolic clinical trial experience preferred., • Relevant healthcare, life science, nursing, pharmacy, or clinical research education or qualification appropriate to the duties delegated by the site., • Current ICH-GCP training required. Candidate must comply with applicable EU and Spanish clinical trial requirements, site procedures, ethics committee requirements, and data-protection standards., • Able to complete site and sponsor onboarding requirements, confidentiality and privacy documentation, occupational health or institutional requirements, system access, and all required study training before beginning work., • Currently resides in Spain, is able to work onsite at the assigned clinical research site, and is legally authorized to provide contracted services in Spain. xcskxlj Prior independent contractor experience is preferred. #J-18808-Ljbffr