Senior Clinical Research Associate – Oncology/Hematology

🔥 0 minutes ago

🇮🇹 Italy – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Lead site qualification, initiation, interim monitoring, management, and close-out activities • Protect patient safety and data quality through informed consent review, source document verification, CRF review, safety information oversight, and data query resolution • Partner with study teams, Project Management, investigators, and site staff on deliverables, milestones, protocol adherence, and site performance • Coordinate CRAs as a Lead CRA on global studies • Provide mentoring, training, accompanied visits, and practical guidance to colleagues and site teams • Maintain regulatory, ethics, site, and TMF documentation • Manage study materials, Investigator Site Files, and investigational product accountability • Prepare and review monitoring visit reports • Contribute to Clinical Monitoring Plans, study tools, protocols, CRFs, training, investigator meetings, and bid defenses • Communicate with sites and study stakeholders and resolve issues throughout the study lifecycle • Travel to investigative sites approximately 6–8 days per month

🎯 Requirements

• MD or Pharmacy degree (MSPH, PharmD, PhD, or equivalent Pharmacy qualification) with at least 3 years of CRA experience; or four-year degree in medical, biological, physical, health, pharmacy, or another related science with at least 5 years of CRA experience; or two-year college curriculum or equivalent education/training, preferably in nursing or life sciences, with at least 7 years of CRA experience • Extensive knowledge of clinical research, GCP, FDA and/or EU regulations and directives, ICH Guidelines, local regulatory requirements, SOPs, monitoring, and site management activities • Strong therapeutic-area knowledge and thorough understanding of two to three therapeutic areas • Communication, planning, organization, interpersonal, problem-solving, and time-management skills • Ability to lead and motivate an assigned team where applicable • Proficiency with Microsoft Office, IxRS, and electronic data capture systems • Valid current passport and driving licence • Willingness to travel • Fluency in the local languages of the countries under responsibility • Proficiency in spoken and written English • Experience in full-service monitoring preferred

🏖️ Benefits

• Collaborative and inclusive work environment • Growth and career development opportunities • Learning opportunities • Home-based work arrangement • Opportunity to contribute as a Lead CRA on global studies • Mentoring and guidance opportunities • Global study team collaboration

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