ph3Overview /h3pSenior Clinical Research Associate (SR CRA) – Spain. The SR CRA is a key member of the Alira Health Clinical team responsible for site monitoring, ensuring compliance and quality of clinical trials. Salary range: €55,000 – €65,000. /ph3Key Responsibilities /h3ulliProvide guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements. /liliReview monitoring visit reports and conduct co‑monitoring and evaluation visits as needed. /liliEnsure appropriate and timely investigator site visits and assist with study recruitment, site training, and other site‑related issues. /liliCoordinate with cross‑functional departments to facilitate negotiation or issue resolution related to clinical trial monitoring. /liliAssist in development of study‑specific Monitoring Plans and training presentations. /liliAssist in setup and collection of site‑specific ethics documents and site contract negotiation. /liliProvide monthly billing information to the finance team. /liliManage study budget and act as referent for the sponsor on stand‑alone monitoring projects. /liliPerform qualification, initiation, interim, and close‑out visits both remotely and onsite, documenting site‑related problems, resolutions, actions, protocol deviations, study progress, and enrollment status. /liliEnsure integrity of CRF data through thorough source document review and verification. /liliPerform quality control and verification of documents collected at sites for eTMF/TMF.



/liliConduct investigational product accountability and review site regulatory binder for required documents. /liliMaintain regular contact with study sites to ensure protocol/GCP compliance, assess patient accrual rates, and respond to sponsor requests. /liliComply with and ensure team compliance with ICH GCP guidelines, FDA regulations, and company/sponsor SOPs. /liliParticipate in internal, client/sponsor, scientific, and other meetings as required. /liliFacilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs. /liliResolve queries on discrepant data in coordination with in‑house CRAs, CTC, and data management. /liliProactively identify site issues and develop problem‑solving strategies. /liliConduct audit preparation at study sites as needed. /liliCollaborate with other CRAs to maintain consistency and promote a collaborative team atmosphere. /liliAssist in CRA new hire training, onboarding, and mentoring. /liliCollaborate in development and maintenance of the Clinical Trial Management System (CTMS). /liliManage and resolve conflicting priorities to deliver on commitments. /liliPerform additional duties as assigned. /li /ulh3Desired Qualifications Experience /h3ulliUS:



BS/BA in a life sciences or related discipline. /liliUS: 3 years of experience in the pharmaceutical/biotechnology/CRO industry, 2 years of clinical monitoring experience, and 1 year of management experience. /liliEU: Minimum 2 years of clinical monitoring experience in the pharmaceutical/biotechnology/CRO industry and the ability to autonomously manage monitoring activities. /li /ulh3Technical Competences Soft Skills /h3ulliQuality focused; detail‑oriented and thorough. /liliStrong organizational and multi‑tasking skills; ability to work effectively in a fast‑paced environment. /liliAbility to manage priorities, organize time, and solve problems. /liliStrong analytical, negotiation, meeting management, cross‑functional team, and leadership skills. /liliAbility to travel and manage stress. /liliProfessional, trustworthy, and disciplined. /liliProblem‑solving unstructured or ambiguous challenges. /liliStrong command of English (US); local language (EU) and local regulations knowledge. /liliExcellent communication and interpersonal skills with customer service orientation. /liliComputer skills; ability to use CTMS, clinical trial databases, and electronic data capture. /liliSelf‑starter in a collaborative but less structured team environment. /liliKnowledge of clinical research, ICH GCP, local regulations, and regulatory and ethical requirements. /liliAbility to establish and maintain positive relationships with sponsor, site, and project team members. /li /ul /p #J-18808-Ljbffr

📌 Senior Clinical Research Associate (Barcelona)
🏢 Alira Health SLU
📍 Barcelona