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CRA in Oncology - Sponsor dedicated - Home Based in Paris Area
Syneos Health
Sponsorship not confirmed
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About the job
Syneos Health · Paris · remote Syneos Health is seeking a CRA in Oncology - Sponsor dedicated to work from home in the Paris Area. The Clinical Research Associate (CRA) will perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance. Key responsibilities include: Performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits Evaluating overall performance of site and site staff, providing recommendations, and communicating/escalating serious issues Verifying informed consent, protecting subject/patient confidentiality, and assessing factors affecting subject/patient safety and clinical data integrity Conducting Source Document Review, verifying clinical data, and applying query resolution techniques Managing investigational product inventory, reconciliation, and storage/security Reviewing Investigator Site File (ISF) and Trial Master File (TMF) Documenting activities and supporting subject/patient recruitment, retention, and awareness strategies Preparing for and attending Investigator Meetings and sponsor face-to-face meetings Providing guidance on audit readiness standards and supporting preparation for audits 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 Excellent communication, presentation, and interpersonal skills Ability to manage required travel of up to 75% on a regular basis Syneos Health offers a dynamic work environment, opportunities for career development, and a Total Rewards program.
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