Senior Clinical Research Associate – Oncology

🔥 0 minutes ago

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

Where this job comes from

Posted on Worldwide Clinical Trials's careers page, not through a job board

First seen by Remote Rocketship 0 minutes ago

Logo of Worldwide Clinical Trials

Worldwide Clinical Trials

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 activities across the study lifecycle, including feasibility, qualification, initiation, interim monitoring, site management, and close-out visits • Monitor protocol adherence, patient safety, informed consent, source documentation, study data, CRFs, and investigational product accountability • Resolve data queries with sites and maintain Investigator Site Files • Complete regulatory and ethics documentation and provide documentation for the Trial Master File • Coordinate CRAs as a Lead CRA on global studies • Work with Project Management to evaluate study deliverables and milestones • Mentor less experienced CRAs and site staff through accompanied visits, training, and guidance • Review site visit reports and provide constructive feedback • Contribute to Clinical Monitoring Plans, protocols, CRFs, study-specific tools, templates, and monitoring/site-management initiatives • Collaborate in study team meetings, investigator meetings, and bid defenses • Maintain regular communication with investigative sites, sponsors, and global study teams

🎯 Requirements

• MD or Pharmacy degree with at least 3 years of CRA experience; or four-year degree in medical, biological, physical, health, pharmacy, or related science with at least 5 years of CRA experience; or two-year college curriculum or equivalent education/training, preferably nursing or life sciences, with at least 7 years of CRA experience • Thorough knowledge of clinical research principles and processes, GCP, ICH Guidelines, applicable FDA and/or EU regulations and directives, local regulatory requirements, and SOPs • Strong understanding of two to three therapeutic areas • Excellent planning, organization, time management, communication, interpersonal, problem-solving, leadership, and mentoring skills • Proficiency with Microsoft Office, IxRS, and EDC systems • Proficiency in spoken and written English, together with fluency in the local language(s) of the countries under responsibility • Valid current passport and driving license • Must reside in Germany and be based within the territory • Willingness and ability to travel to investigative sites approximately 6–8 days per month

🏖️ 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 training opportunities • Opportunity to help bring life-changing therapies to patients

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