Senior clinical research associate

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8i0g1n

Summarythe senior clinical research associate (senior cra) is a key member of the alira health clinical team, responsible for independent site monitoring and providing oversight, leadership and guidance in the execution of clinical trials.key responsibilitiesprovide guidance, oversight and feedback to the cra team to ensure adherence to project scope, sops, timelines and budget.review monitoring visit reports and conduct co-monitoring and evaluation visits as needed.ensure appropriate and timely investigator site visits.coordinate with cross-functional departments to facilitate negotiation and issue resolution for clinical trial monitoring.assist in the development of study-specific monitoring plans and training presentations.support set-up, collection of site-specific ethics documents and site contract negotiation.provide monthly billing information to the finance team.manage study budgets for stand-alone projects and act as sponsor referent.perform qualification, initiation, interim and close-out visits both remotely and on-site, documenting all activities.prepare accurate monitoring visit reports, documenting site problems, resolutions, protocol deviations, progress and enrollment status.ensure integrity of crf data through thorough source document review and verification.perform quality control and verification of documents collected at sites for etmf/tmf.conduct investigational product accountability and review site regulatory binders.maintain regular contact with study sites to ensure gcp compliance,



assess patient accrual rates and respond to sponsor requests.facilitate adverse event reporting and reconcile sae reports with source documentation and crfs.work closely with in-house cras, ctc and data management to resolve data queries.identify site issues proactively and develop problem-solving strategies.conduct audit preparation at study sites as needed.promote a collaborative team atmosphere and ensure consistency across cras.participate in internal, client and sponsor scientific meetings.assist in cra new-hire training, onboarding and mentoring.collaborate on the development and maintenance of the clinical trial management system (ctms).manage and resolve conflicting priorities to meet commitments.perform additional duties as assigned.desired qualificationsminimum 4 years of clinical monitoring experience in the pharmaceutical/biotechnology cro industry.experience in oncology trials.ability to travel across italy.permanent authorization to work in italy.certified monitor in compliance with italian cro decree (15 nov 2011).university degree in a scientific or health-related field.technical competencesstrong command of english (written and verbal).strong command of italian (written and verbal).proficient with clinical trial management systems, clinical trial databases and electronic data capture.knowledge of ich-gcp, local regulations, and ethical requirements.soft skillsquality-focused, careful, thorough and detail-oriented.strong organizational, analytical, negotiation and leadership skills.ability to manage priorities, work under stress and solve unstructured challenges.excellent communication and interpersonal skills with a customer-service orientation.salary rangeeur 45 000 - 60 000 (final offer dependent on location, experience and qualifications).

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8i0g1n