Job Description
Perform site visits and monitor activities in accordance with protocol, GCP/ICH Guidelines, and applicable regulatory requirements, from SIV to SCV (phase I-IV)- Mentor CRAs on monitoring, collaborate on procedures development, and query resolution.
- Review and verify case report forms and other clinical data for completeness and accuracy.
- Generate queries and manage resolutions with site staff.
- Maintain project tracking systems as required.
- Use expertise to identify and resolve complex site issues and deficiencies in documentation, communication, and the need for additional training.
- Identify protocol deviations or major risks to data integrity.
- Provide recommendations regarding site-specific actions.
- Act as a liaison between the company and study site personnel and be able to respond to site concerns and questions.
- IMP supply and control.
- Remote work will be approximately 90% of the time.Número de vacantes: 1Modalidad de trabajo...