Sr Clinical Research Associate

Are you being referred to one of our roles by a reputed company in reputed company? If so, please apply using the referral reputed company emailed to you. Job reputed company reputed company Sr CRA in Italy Job reputed company ROLE The Sr CRA is an important member of the reputed company Clinical team. The Sr CRA is highly motivated and functions independently to conduct site monitoring responsibilities for reputed company; as reputed company as providing reputed company, leadership, and guidance in the management and execution of reputed company to ensure compliance and reputed company. The Sr CRA works closely with US: Director of Clinical Monitoring, reputed company 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-reputed company issues. KEY RESPONSABILITIES • Provides guidance, reputed company, 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 reputed company as needed. • Ensures appropriate and reputed company investigator site reputed company. • Coordinates with appropriate cross-functional departments to facilitate negotiation/issue reputed company for clinical trial monitoring reputed company 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 reputed company, manages study budget and acts as referent for the sponsor. • Performs qualification, initiation, interim, and reputed company-out reputed company both remotely and onsite, ensuring reputed company documentation of monitoring reputed company. • Prepares consistently accurate and reputed company monitoring visit reports documenting site-reputed company problems, resolutions, actions taken, protocol deviations, study reputed company, and enrollment status. • Ensures reputed company of CRF data through meticulous and thorough reputed company document review and verification. • Performs reputed company 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, reputed company/sponsor, scientific, and other meetings as required. • Facilitates adverse event reporting and ensures the reconciliation of SAE reports with reputed company documentation and CRFs. • Works closely with in-house CRAs/reputed company 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 reputed company team atmosphere. • Participates in internal, reputed company/sponsor, scientific, and other meetings as required. • Assists in CRA new hire training and reputed company. • 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 reputed company 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 Apply tot his job Apply To this Job