Senior Clinical Research Associate – CNS, Immunology

🔥 6 minutes ago

🇩🇪 Germany – 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 in accordance with study protocols, GCP, applicable regulations, and SOPs • Review informed consent, source documentation, CRFs, safety information, and protocol compliance to protect patient safety and data quality • Resolve data queries with investigative sites • Maintain regulatory and site documentation • Manage investigational product accountability • Support timely and accurate study data • Coordinate site regulatory and ethics documentation, study materials, and Trial Master File documentation • Serve as a Lead CRA on global studies when required • Coordinate CRAs and contribute to monitoring plans, study-specific tools, templates, and visit report reviews • Mentor less experienced CRAs and site staff through guidance, training, accompanied visits, and constructive feedback • Collaborate with Project Management and study teams to evaluate deliverables and milestones • Participate in investigator meetings and bid defenses • Contribute monitoring and site-management expertise to protocol and CRF design, process initiatives, and study team training

🎯 Requirements

• MD or Pharmacy qualification with at least 3 years of CRA experience; or a four-year college qualification in a medical, biological, physical, health, pharmacy, or related science with at least 5 years of CRA experience; or a two-year college qualification or equivalent education/training, preferably in nursing or life sciences, with at least 7 years of 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 relevant SOPs • Strong knowledge of two to three therapeutic areas • Excellent communication, interpersonal, planning, organization, time-management, initiative, leadership, and problem-solving skills • Proficiency with Microsoft Office, IxRS, and EDC systems • Valid current passport and driving licence, with willingness to travel • Fluency in the local language(s) of the countries under responsibility • Proficiency in spoken and written English • Candidates must reside within Germany to support site visits and study activities • Approximately 6-8 days of travel to investigative sites per month

🏖️ Benefits

• Collaborative and inclusive work environment • Growth and learning opportunities • Home-based/remote work arrangement • Opportunity to support global studies as a Lead CRA • Mentoring and training opportunities • Opportunity to contribute to monitoring plans, study tools, templates, and training • Opportunity to participate in investigator meetings and bid defenses

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