Are you being referred to one of our roles by a connection in Alira Health? Join our general team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. SummarySr CRA in SpainJob DescriptionROLEThe Sr CRA is an important member of the Alira Health Clinical team. The Sr CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. The Sr CRA works closely with US: Director of Clinical Monitoring, Lead CRAs, in-house CRAs, EU: Associate Director of Clinical Monitoring, CRAs, and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. KEY RESPONSABILITIESProvides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements. Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed. Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues. Assists in development of study-specific Monitoring Plans and training presentations as required. Assists in set up/collection of site specific ethics documents and site contract negotiation as required. Provides monthly billing information to finance team as required. For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor. Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits. Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions,



actions taken, protocol deviations, study progress, and enrollment status. Ensures integrity of CRF data through meticulous and thorough source document review and verification. Performs quality control and verification of documents collected at sites for eTMF/TMF.Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs. Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data. Assists in CRA new hire training and onboarding. Collaborates with development and maintenance of Clinical Trial Management System (CTMS).Minimum 3 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry and ability to autonomously manage monitoring activities Experience in OncologyAvailability to travelTECHNICAL COMPETENCES & SOFT SKILLS Quality focused; US: Strong command of English, both written and verbal EU: Strong command of Local language, both written and verbal, in the country where monitoring activities are performedExcellent communication and interpersonal skills with customer service orientation Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data captureSelf-starter who thrives in a collaborative, yet less structured team environment Knowledge of clinical research, ICH GCP and local regulations Knowledge of Regulatory and Ethical requirements Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members US: Permanent authorization to work in the U.Certified Monitor in compliance with Italian CRO decree dated 15Nov2011. EU: Graduation in a scientific health field. EU: Adequate English LanguagesEnglishEducationBachelor of Science (BS): Biology, Bachelor of Science (BS): Biotechnology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Barcelona-RemoteType: Full time

📌 Research Associate (Barcelona)
🏢 Alira Health
📍 Barcelona