Description
Syneos Health is seeking a CRA II in Oncology to work in a home-based setting in the Paris area.
The successful candidate will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
Key responsibilities include:
- Evaluating the overall performance of site and site staff, providing recommendations, and escalating serious issues to the project team
- Verifying the process of obtaining informed consent and protecting subject/patient confidentiality
- Assessing site processes, conducting source document reviews, and verifying clinical data accuracy and completeness
- Applying query resolution techniques and providing guidance to site staff
- Managing investigational product inventory, reconciliation, and storage and security
- Reviewing the Investigator Site File and Trial Master File for accuracy and completeness
- Documenting activities and supporting subject/patient recruitment, retention, and awareness strategies
- Understanding project scope, budgets, and timelines, and managing site-level activities to meet project objectives
- Acting as a primary liaison with study site personnel and attending investigator meetings and sponsor face-to-face meetings
- Providing guidance on audit readiness standards and supporting preparation for audits
The ideal candidate will have:
- A 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 range of benefits, including career development and progression opportunities, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards programs.
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