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Job Description

Summary 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. KEY RESPONSABILITIES

• Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.
• Reviewsmonitoring 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 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.
• Reviews site regulatory binder for required documents.
• Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests.
• Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs.
• Participates in internal, client/sponsor, scientific, and other meetings as required.
• Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs.
• Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data.
• Proactively identifies site issues and develops problem-solving strategies for sites.
• Conducts audit preparation at study sites as needed.
• Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.
• Participates in internal, client/sponsor, scientific, and other meetings as required.
• Assists in CRA new hire training and onboarding.
• Performs CRA mentoring.
• Collaborates with development and maintenance of Clinical Trial Management System (CTMS).
• Manages and resolves conflicting priorities to deliver on commitments.
• Performs additional duties as assigned.

DESIRED QUALIFICATION & EXPERIENCE

• US: BS/BA from an undergraduate program (life sciences or related discipline preferred)
• US: 3 years of experience in the pharmaceutical / biotechnology / CRO industry, 2 year of clinical monitoring experience with 1 year of management experience
• EU: Minimum 2 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry and ability to autonomously manage monitoring activities