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

PMFarma; Gijón; A distancia; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading company in the clinical research field is seeking a Clinical Monitor to perform site visits and oversee clinical trial activities in compliance with protocols and regulations. The role involves mentoring staff, ensuring data integrity, and handling complex site issues, primarily through remote work. Candidates should possess a Bachelor's degree in Science and have at least one year of clinical monitoring experience, preferably in Oncology.

Formación

• Fluency in English is essential.
• Prior 1 year of clinical monitoring experience, preferably in Oncology.

Responsabilidades

• Perform site visits and monitor activities per protocol and regulatory requirements.
• Mentor CRAs on monitoring and review clinical data for completeness.
• Act as a liaison between the company and study site personnel.

Conocimientos

Excellent communication

Presentation skills

Interpersonal skills

Fluency in English

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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