Senior Clinical Research Associate – Onco/CNS

🔥 0 minutes ago

🇪🇸 Spain – 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 integrity through informed consent and safety-information review, source document verification, CRF review, and query resolution • Guide sites on protocol adherence, Investigator Site File maintenance, regulatory and ethics documentation, investigational product accountability, and ongoing study requirements • Coordinate CRAs as a Lead CRA on global studies • Mentor and train less experienced colleagues and site staff, including accompanied visits • Partner with Project Management and study teams on deliverables, study milestones, site performance, and monitoring activities • Develop monitoring plans, study-specific tools, templates, and training materials • Review site visit reports and provide feedback and edits • Ensure site documentation is maintained for filing in the Trial Master File • Contribute clinical monitoring expertise to study team and investigator meetings, bid defenses, and protocol and CRF design

🎯 Requirements

• MD or Pharmacy qualification (MSPH, PharmD, PhD, equivalent Pharmacy degree, or similar) with at least 3 years’ CRA experience; or minimum four-year college curriculum in a relevant science with at least 5 years’ CRA experience; or two-year college curriculum or equivalent education/training, preferably nursing or equivalent life science degree, with at least 7 years’ CRA experience • Extensive knowledge of clinical research principles and processes • Thorough understanding of FDA and/or EU regulations and directives, ICH Guidelines, local regulatory requirements, and SOPs • Strong therapeutic-area expertise in two to three therapeutic areas • Excellent communication, interpersonal, planning, organizational, time-management, initiative, and problem-solving skills • Ability to lead and motivate an assigned team when applicable • Technical proficiency with Microsoft Office, IxRS, and electronic data capture (EDC) systems • Valid current passport and driving licence • Willingness to travel as required • Proficiency in spoken and written English • Fluency in the local languages of the countries under responsibility

🏖️ Benefits

• Collaborative and inclusive work environment • Growth and learning opportunities • Home-based work arrangement • Opportunity to act as Lead CRA on global studies • Mentoring and training opportunities • Global study team collaboration

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