Description
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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