Senior Clinical Research Associate
hace 5 días
Barcelona
Overview In this role you will lead and oversee clinical trial monitoring as a senior CRA within Alira Health’s global Clinical team. You will work independently and with cross-functional partners to ensure protocol compliance, quality, and timely site visits across Spain and Europe. You will shape monitoring plans, mentor junior CRAs, and collaborate with sponsors to resolve site issues, driving project success and study timelines. This position offers exposure to international teams and a mission-driven, inclusive culture. Compensaciones / Beneficios • remote work, • international team, • competitive salary range 55k-70k, • full-time contract, • location flexibility (Barcelona-Remote; Europe-Remote), • professional development opportunities Responsabilidades, • Provide guidance and oversight to the CRA team to meet scope, SOPs, timelines, and budgets, • Review monitoring visit reports and conduct co-monitoring and evaluation visits as needed, • Coordinate with cross-functional departments to resolve monitoring-related issues, • Assist in development of monitoring plans and training materials, • Assist in ethics documents setup and site contract negotiation, • Provide monthly billing information to finance, • Manage study budget for monitoring stand-alone projects and act as sponsor referent, • Perform qualification, initiation, interim, and close-out visits both remotely and onsite, • Document monitoring visits with clear reports on problems, resolutions, and enrollment status, • Ensure data integrity through source document review and eTMF/TMF verification, • Conduct investigational product accountability and review regulatory binders, • Maintain site communication to ensure GCP compliance and address sponsor requests, • Comply with ICH GCP, FDA regulations, and SOPs; participate in required meetings, • Facilitate adverse event reporting and reconcile SAE with sources and CRFs, • Collaborate with CRAs, data management to resolve data discrepancies, • Identify site issues and develop problem-solving strategies, • Support CRA onboarding and mentoring; contribute to CTMS maintenance, • Manage conflicting priorities to deliver on commitments, • Perform additional duties as assigned Requisitos principales, • BS/BA in life sciences or related discipline (US), • 3 years in pharma/biotech/CRO with 2 years clinical monitoring and 1 year management experience (US), • EU: at least 2 years of clinical monitoring experience with capability to autonomously manage monitoring activities, • Strong knowledge of ICH GCP and regulatory requirements, • Excellent communication and interpersonal skills; customer service orientation, • Ability to travel and manage stress; professional and trustworthy, • English proficiency (US) or Local language proficiency (EU), • Graduation in a scientific health field (EU), • Adequate English (EU), • quality-focused, • highly organized and multi-tasking, • problem-solving and negotiation, • CTMS knowledge, • eTMF/TMF documentation and verification, • clinical trial databases and electronic data capture
Entrevistas mañana
112 Carrer de la Diputació, Eixample, 08015, Barcelona
