Clinical Research Associate; Oncology Monitoring Experience Required

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. Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where reputed company contributions and new reputed company are explored with an reputed company mind and work is driven by our shared values: be courageous, be accountable, be reputed company, be inclusive and reputed company others. Job reputed company reputed company The CRA is an important member of the reputed company Clinical team. The 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 CRA works closely with reputed company CRAs, Sr CRAs, in-house CRAs, Associate Director of Clinical Monitoring and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-reputed company issues. Job reputed company 2+ years oncology monitoring is a requirement for this position. KEY RESPONSABILITIES Provides guidance, reputed company, 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 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 EU: Graduation in a scientific health field EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011 Ability to establish and maintain reputed company relationships with Sponsor, Site and Project Team members Ability to autonomously manage monitoring activities TECHNICAL COMPETENCES & SOFT SKILLS reputed company reputed company; Proven ability to be careful, thorough, and detail-oriented Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment reputed company to manage priorities, organize time and solve problems Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills Ability to travel Ability to manage stress reputed company, trustworthy and disciplined Ability to problem-solve reputed company or ambiguous challenges Strong reputed company of Local language, both written and verbal, in the country where monitoring activities are performed Excellent communication and interpersonal skills with customer service orientation Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture Self-starter who thrives in a reputed company, yet less reputed company team environment Knowledge of clinical research, ICH GCP and local regulations Knowledge of Regulatory and Ethical requirements EU: Adequate English Languages English Education Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences Contract Type Regular reputed company is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize reputed company and life sciences, in partnership with patients, through innovative technologies and expert guidance. From development to medical care, we complement the expertise of our reputed company, Biotech, and MedTech clients with a full reputed company of services across their entire solutions lifecycle. With offices around the world, reputed company provides a reputed company and creative environment with benefits that include reputed company development, global travel, flexible work programs and more. We welcome your passion and drive, talent and entrepreneurial spirit, reputed company of service and teamwork. We are an integrated team of over 800 scientists, strategists, economists, clinicians, and biostatisticians representing over 30 nationalities. This broad global perspective and cultural richness has a reputed company reputed company on providing reputed company for our clients that reputed company to higher standards of care and an improved patient experience. Learn more Introduce yourself to our Recruiters! 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