Ile-379 - Senior Clinical Research Associate

We are looking for a Senior Clinical Research Associate for our Clinical Development & Operations Team based in our Barcelona Office. Start date: ASAPRequired education:Bachelor's or Master's Degree in life science or healthcare; or equivalent combination of education, training, and experienceResponsibilities:Monitor study sites independently (presential or remote) according to the protocol monitoring guidelines, SOPs, GCP ICH guidelines, ISO14155 and FDA regulation (selection, initiation, monitoring and close-out)Manage assigned sites by regular contacts with site personnel to ensure site compliance, adequate enrolment and understanding of study requirementsSupport study sites by acting as a liaison between the site and clinical vendors (CROs)Perform CRF review, query generation and resolution against established data review guidelines or data management systems as applicableParticipate in the set up ISF and SMFParticipate in the maintenance and management of the relevant project tracking systems established in the project plansParticipate in ordering, shipment, and management of study suppliesPreparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-active follow of each, individual CAPA until timely resolutionParticipate in the review, design and development of clinical research documents (e.G., Protocols, Case Report Forms, Reports and Statistical analysis)Participate in creation and review of SOPsRequirements:4 years of experience working in a clinical environment or medical setting, as a CRA from either a pharma/med device company or a CRO environmentExperience in neuro-related therapeutic areas and technical knowledge of medical devices will be consideredHigh level of knowledge and regulatory requirements of ICH GCP Guidelines, SOPs, ISO14155 as well as FDA regulationStrong interest in clinical researchExperience in CT audits/ inspectionsExcellent written and oral communication skills (English is a must)Ability to read, analyze, and interpret common scientific and technical journalsAffinity to work effectively and efficiently in a matrix environmentStrong organizational and skills, with emphasis on team player attitude and team-building skillsAbility to manage multiple tasks in a fast-paced environment with changing prioritiesVery good interpersonal and negotiation skills#J-18808-Ljbffr