Senior Clinical Research Associate – Oncology, CNS

🔥 0 minutes ago

🇵🇱 Poland – 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 • Monitor study quality and patient safety through source document verification, informed consent and safety information review, CRF review, and support with data query resolution • Build relationships with investigators and site teams, providing communication, protocol guidance, training, and support throughout the study lifecycle • Maintain regulatory, ethics, Investigator Site File, TMF, and investigational product documentation and accountability requirements • Partner with Project Management and study teams to evaluate deliverables, study milestones, site performance, and monitoring requirements • Coordinate CRAs as a Lead CRA on global studies, including reviewing visit reports and providing mentoring, guidance, and accompanied site visits • Develop monitoring plans, study-specific tools, templates, and training materials • Contribute clinical monitoring expertise to study team and investigator meetings, bid defenses, protocols, CRFs, and process initiatives • Travel to investigative sites approximately 8–10 days per month

🎯 Requirements

• MD or Pharmacy degree with at least 3 years of CRA experience; or a four-year degree in medical, biological, physical, health, pharmacy, or a related science with at least 5 years of CRA experience; or a two-year college curriculum or equivalent education/training, preferably in nursing or life sciences, with at least 7 years of CRA experience • Experience in full-service monitoring preferred • Strong clinical research expertise • Thorough understanding of GCP, ICH Guidelines, FDA and/or EU regulations and directives, local regulatory requirements, and SOPs • Experience in Oncology required; CNS experience is an advantage • Excellent communication, interpersonal, planning, organization, time-management, initiative, and problem-solving skills • Ability to lead and motivate others when applicable • Proficiency with Microsoft Office, IxRS, and EDC systems • Fluency in Polish and proficiency in spoken and written English • Valid current passport and driving license • Willingness to travel as required • Must reside in Poland

🏖️ Benefits

• Collaborative and inclusive environment • Growth and career development opportunities • Opportunity to learn and grow • Meaningful work contributing to life-changing therapies • Global collaboration and exposure to diverse perspectives

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