pJoin our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. /ph3Job Description Summary /h3pSr CRA in Italy /ph3ROLE /h3pThe Sr CRA is an important member of the Alira Health Clinical team. The Sr CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. The Sr CRA works closely with US: Director of Clinical Monitoring, Lead CRAs, in-house CRAs, EU: Associate Director of Clinical Monitoring, CRAs, and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. /ppSalary Range: eur 45,000 - 60,000 /ph3KEY RESPONSIBILITIES /h3ulliProvides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements. /liliReviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed. /liliEnsures appropriate and timely investigator site visits. /liliCoordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues. /liliAssists in development of study-specific Monitoring Plans and training presentations as required. /liliAssists in set up/collection of site specific ethics documents and site contract negotiation as required. /liliProvides monthly billing information to finance team as required. /liliFor monitoring stand-alone projects,



manages study budget and acts as referent for the sponsor. /liliPerforms qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits. /liliPrepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status. /liliEnsures integrity of CRF data through meticulous and thorough source document review and verification. /liliPerforms quality control and verification of documents collected at sites for eTMF/TMF. /liliConducts investigational product accountability. /liliReviews site regulatory binder for required documents. /liliMaintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests. /liliComplies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs. /liliParticipates in internal, client/sponsor, scientific, and other meetings as required. /liliFacilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs. /liliWorks closely with in-house CRAs/CTC and data management to resolve queries on discrepant data. /liliProactively identifies site issues and develops problem-solving strategies for sites. /liliConducts audit preparation at study sites as needed.



/liliWorks with other CRAs to maintain consistency and promote a collaborative team atmosphere. /liliParticipates in internal, client/sponsor, scientific, and other meetings as required. /liliAssists in CRA new hire training and onboarding. /liliPerforms CRA mentoring. /liliCollaborates with development and maintenance of Clinical Trial Management System (CTMS). /liliManages and resolves conflicting priorities to deliver on commitments. /liliPerforms additional duties as assigned. /li /ulh3DESIRED QUALIFICATION EXPERIENCE /h3ulliEU: Minimum 4 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry and ability to autonomously manage monitoring activities /liliAvailabilities to travel in Italy /liliOncology Experience required /li /ulh3TECHNICAL COMPETENCES SOFT SKILLS /h3ulliQuality focused; Proven ability to be careful, thorough, and detail-oriented /liliStrong organizational skills and the ability to multi-task and work effectively in a fast-paced environment /liliAble to manage priorities, organize time and solve problems /liliStrong analytical, negotiation, meeting management, cross-functional team, and leadership skills /liliAbility to travel /liliAbility to manage stress /liliProfessional, trustworthy and disciplined /liliAbility to problem-solve unstructured or ambiguous challenges /liliUS: Strong command of English, both written and verbal /liliEU: Strong command of Local language, both written and verbal, in the country where monitoring activities are performed /liliExcellent communication and interpersonal skills with customer service orientation /liliGood computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture /liliSelf-starter who thr /li /ul #J-18808-Ljbffr

📌 Senior Clinical Research Associate (Italia)
🏢 Alirahealth
📍 Italia