This role involves conducting comprehensive monitoring activities across clinical sites engaged in Neurology and Immunology studies within a Functional Service Provider framework. As a CRA II, you will manage site relationships from qualification through close-out, ensuring adherence to ICH-GCP, local regulations, and study protocols.
What You'll Do
- Conduct on-site and remote monitoring visits including site initiation, interim checks, and close-out
- Evaluate site performance and recommend corrective actions when necessary
- Verify informed consent procedures are properly documented and maintained
- Review source documents and case report forms to ensure data accuracy and completeness
- Support query resolution within defined timelines using remote and on-site techniques
- Assess compliance with electronic data capture requirements and clinical monitoring plans
- Monitor investigational product handling, including storage, dispensing, and accountability
- Review Investigator Site Files and align content with the Trial Master File
- Document all monitoring activities through trip reports, letters, and logs per SOPs
- Support recruitment strategies and track site-level progress against study goals
Requirements
- Proven understanding of ICH-GCP, regulatory standards, and clinical trial protocols
- Experience in site monitoring with strong judgment in identifying compliance risks
- Ability to assess patient safety factors and data integrity issues at investigative sites
- Familiarity with pharmacovigilance procedures and protocol deviation management
- Proficiency with clinical data systems and digital monitoring tools
- Knowledge of proper IP labeling, importation, and reconciliation processes
- Strong organizational skills to manage multiple sites and shifting priorities
- Willingness to travel frequently, up to 75%, primarily within Turkey
Benefits
Work from home with flexible scheduling, supported by a structured FSP environment. Gain exposure to complex therapeutic areas with opportunities for professional growth. Access training resources and standardized processes to support consistent performance across global studies.
