Senior Clinical Research Associate – Oncology

🔥 0 minutes ago

🇫🇷 France – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Ensure compliance with study protocols, ICH-GCP guidelines, regulatory requirements, and company procedures across assigned sites • Evaluate site performance, recommend site-specific actions, escalate significant issues, and support corrective action plans • Verify informed consent processes are appropriately conducted and documented • Assess patient safety and clinical data integrity by identifying protocol deviations, violations, pharmacovigilance concerns, and other site-level risks • Conduct remote and on-site monitoring according to the Clinical Monitoring Plan and Study Monitoring Plan • Perform source document review and verification and ensure case report form data is accurate, complete, and supported by source documentation • Manage protocol deviation reporting, follow-up activities, and resolution of data queries • Review investigational product accountability, storage, security, dispensing, administration, reconciliation, and related documentation • Document monitoring findings and study activities through monitoring reports, follow-up letters, communication logs, and required study documentation • Ensure appropriately trained and delegated site personnel perform study activities • Track observations, action items, site status, and study progress in required systems and tracking tools • Review site documentation, training compliance, delegation logs, enrollment logs, accountability records, and other essential study records for inspection readiness • Participate in investigator, sponsor, monitoring, and project team meetings • Collaborate with the primary Site Manager and stakeholders to support study objectives, deliverables, and timelines

🎯 Requirements

• Bachelor's degree, Registered Nurse (RN), or an equivalent combination of education, training, and experience • Experience in clinical research monitoring with oncology trial experience and knowledge of RECIST criteria • Knowledge of ICH-GCP, applicable regulatory requirements, and clinical trial processes • Experience conducting on-site and remote monitoring activities • Strong verbal and written communication, presentation, organizational, and interpersonal skills • Ability to build and maintain effective relationships with investigator site personnel and study stakeholders • Proficiency in the local language • Advanced-level or fluent English language skills • Experience working within sponsor-dedicated clinical research environments preferred

🏖️ Benefits

• Remote/home-based work arrangement • Continuous learning and professional development • Flexible work environment • Growth-oriented environment • Meaningful impact through contributing to innovative therapies and clinical research