Research Associate

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The 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.* Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.* Reviews monitoring visit reports,



conducts co-monitoring and evaluation visits as needed.* Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues.* Assists in development of study-specific Monitoring Plans and training presentations as required.* Assists in set up/collection of site specific ethics documents and site contract negotiation as required.* Provides monthly billing information to finance team as required.* For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor.* Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits.* Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.* Ensures integrity of CRF data through meticulous and thorough source document review and verification.* Performs quality control and verification of documents collected at sites for eTMF/TMF.* Conducts investigational product accountability.* Maintains regular contact with st

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78doyx