Sr CRA FSP Sponsor Dedicated
Remote · Turkey or TR
Job Summary
Senior CRA responsible for site qualification, initiation, interim monitoring, site management and close-out visits (on-site or remote), ensuring regulatory, ICH-GCP and GPP compliance. Applies judgment to evaluate site performance, communicates/escalates serious issues, and develops action plans. Maintains knowledge of ICH/GCP guidelines and SOPs. Verifies informed consent documentation, protects subject confidentiality, and assesses safety/data integrity. Performs Source Document Review and medical records verification, ensures accurate CRFs, applies remote/on-site query resolution, supports IP inventory and distribution, and ensures IP labeling/release per protocol. Reviews ISF and TMF, maintains audit readiness, supports subject recruitment/retention, facilitates data entry, and tracks observations. Travel up to 75% may be required. Requires excellent communication and computer skills, and ability to adapt to changing priorities. Knowledge of GCP/ICH and local regulations is essential.
Required Qualifications
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
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