19 ott - Verona
Alira Health
Job Description Summary
Competenze, Esperienza, Qualifiche: se possiede i requisiti giusti per questa possibilità, si candidi oggi stesso.
Sr CRA in Italy
Job Description
ROLE
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.
Salary Range: eur 45,000 - 60,000
Key Responsibilities
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- 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.
- Ensures appropriate and timely investigator site visits.
- 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 pro
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