Clinical Research Associate (CRA) GEIS-Grupo Español de Investigación en Sarcomas calendar_mont[...]

PMFarma; Santiago de Compostela; A distancia; EUR 35.000 - 45.000; Jornada completa

Descripción de la vacante

A leading company in clinical research is seeking a Clinical Research Associate in Santiago de Compostela. The role involves extensive site monitoring, mentoring CRAs, and ensuring compliance with regulatory standards. Remote work is primarily offered, allowing flexibility along with essential site responsibilities.

Formación

• Bachelor's degree in Science or equivalent education.
• 1 year of clinical monitoring experience, preferably in Oncology.
• Fluency in English.

Responsabilidades

• Perform site visits and monitor activities per protocol and GCP/ICH guidelines.
• Mentor CRAs and manage query resolutions.
• Act as a liaison between the company and study site personnel.

Conocimientos

Communication

Interpersonal Skills

Presentation Skills

Educación

Bachelor's degree in Science

Descripción del empleo

• 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.
• 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.
• Bachelor's degree in Science or equivalent combination of education, training and experience.
• Prior 1 year of clinical monitoring experience (preferably in Oncology).
• Fluency in English.
• Excellent communication, presentation, interpersonal skills, both written and spoken.

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