ph3Sr CRA Spain /h3 pThe Senior Clinical Research Associate (Sr CRA) is a key member of the Alira Health Clinical team. The Sr CRA independently conducts site monitoring activities, oversees clinical trial execution, and ensures protocol compliance and quality throughout the study life cycle. /p h3Responsibilities /h3 ul liProvides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements. /li liReviews monitoring visit reports, conducts co‑monitoring and evaluation visits as needed. /li liEnsures appropriate and timely investigator site visits. /li liCoordinates with cross‑functional departments to facilitate negotiation and issue resolution for monitoring related issues. /li liAssists in development of study‑specific monitoring plans and training presentations. /li liAssists in set up/collection of site‑specific ethics documents and site contract negotiation. /li liProvides monthly billing information to finance team. /li liFor monitoring stand‑alone projects, manages study budget and acts as referent for the sponsor. /li liPerforms qualification, initiation, interim, and close‑out visits both remotely and onsite, ensuring proper documentation. /li liPrepares accurate monitoring visit reports documenting site‑related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status. /li liEnsures integrity of CRF data through meticulous source document review and verification. /li liConducts quality control and verification of documents collected at sites for eTMF/TMF. /li liConducts investigational product accountability. /li liReviews site regulatory binder for required documents. /li liMaintains regular contact with study sites to ensure protocol/GCP compliance,



assesses patient accrual rates, and responds to sponsor requests. /li liComplies with ICH GCP guidelines, FDA regulations, and company/sponsor SOPs. /li liParticipates in internal, client/sponsor, scientific, and other meetings as required. /li liFacilitates adverse event reporting and ensures reconciliation of SAE reports with source documentation and CRFs. /li liWorks closely with in‑house CRAs/CTC and data management to resolve queries on discrepant data. /li liProactively identifies site issues and develops problem‑solving strategies. /li liConducts audit preparation at study sites as needed. /li liCollaborates with other CRAs to maintain consistency and promote a collaborative team atmosphere. /li liAssists in CRA new hire training and onboarding. /li liPerforms CRA mentoring. /li liCollaborates with development and maintenance of the Clinical Trial Management System (CTMS). /li liManages and resolves conflicting priorities to deliver on commitments. /li liPerforms additional duties as assigned. /li /ul h3Qualifications and Experience /h3 ul liUS: BS/BA from an undergraduate program (life sciences or related discipline preferred). /li liUS: 3 years of experience in the pharmaceutical/biotechnology/CRO industry, 2 years of clinical monitoring experience with 1 year of management experience. /li liEU:



Minimum 2 years of clinical monitoring experience in the pharmaceutical/biotechnology/CRO industry and ability to autonomously manage monitoring activities. /li /ul h3Technical Competencies Soft Skills /h3 ul liQuality focused; proven ability to be careful, thorough, and detail‑oriented. /li liStrong organizational skills and the ability to multi‑task in a fast‑paced environment. /li liAbility to manage priorities, organize time, and solve problems. /li liStrong analytical, negotiation, meeting management, cross‑functional team, and leadership skills. /li liAbility to travel. /li liAbility to manage stress. /li liProfessional, trustworthy, and disciplined. /li liAbility to problem‑solve unstructured or ambiguous challenges. /li liUS: Strong command of English, both written and verbal. /li liEU: Strong command of local language, both written and verbal, in the country where monitoring activities are performed. /li liExcellent communication and interpersonal skills with customer service orientation. /li liGood computer skills, ability to use clinical trial management systems, clinical trial databases, and electronic data capture. /li liSelf‑starter who thrives in a collaborative, yet less structured team environment. /li liKnowledge of clinical research, ICH GCP, and local regulations. /li liKnowledge of regulatory and ethical requirements. /li liAbility to establish and maintain positive relationships with sponsor, site, and project team members. /li liEU: Graduation in a scientific health field. /li liEU: Adequate English. /li /ul h3Languages /h3 pEnglish /p h3Education /h3 pBachelor of Science (BS): Biology, Biotechnology, Life Sciences, or Pharmacy /p h3Contract Type /h3 pRegular /p h3Salary Range /h3 p€55,000 – €65,000 /p /p #J-18808-Ljbffr

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