22 sep
|
Alira Health
|
Barcelona
22 sep
Alira Health
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 / Incentivos 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
📌 Senior Clinical Research Associate (Barcelona)
🏢 Alira Health
📍 Barcelona