Senior CRA, Oncology

🔥 0 minutes ago

🇫🇷 France – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Perform site qualification, site initiation, interim monitoring, site management and close-out visits on-site or remotely • Ensure regulatory, ICH-GCP/GPP and protocol compliance • Evaluate site and site staff performance and provide recommendations and action plans • Verify informed consent processes, subject/patient confidentiality, safety and clinical data integrity • Conduct source document review and verify clinical data in case report forms • Resolve queries remotely and on site and guide site staff • Review investigational product inventory, storage, dispensing and administration as applicable • Review Investigator Site Files and reconcile them with the Trial Master File • Document monitoring activities and maintain tracking systems • Support subject/patient recruitment, retention and awareness strategies • Manage site-level activities, communications, deliverables and timelines • Liaise with project site personnel and ensure site team training and compliance • Prepare for and attend investigator and sponsor meetings • Participate in or lead clinical monitoring/project staff meetings as applicable • Support audit readiness and follow-up actions • Provide training or mentorship to junior CRAs • For RWLP studies, support sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsors and local teams, identify sites, develop country-level informed consent forms, support regulatory updates and participate in bid defense meetings

🎯 Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements • Good computer skills and ability to embrace new technologies • Excellent communication, presentation and interpersonal skills • Basic level of critical thinking skills • Ability to manage required travel of up to 75% on a regular basis

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations when appropriate

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