If you are Senior Clinical Research Associate looking to take a step up in your career, ANTAEA Group of Companies offers you the opportunity to join one of the biggest Pharmaceutical Companies based in Athens.

Position Overview:
The Sentior Clinical Research Associate will perform clinical monitoring activities following study guidelines, SOPs, and applicable regulations. This position is responsible for ensuring the overall integrity of assigned studies through the use of independent judgement and expertise to assess adherence to study protocol and regulations.

Responsibilities:
• Perform site visits and monitor activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements.
• Use expertise and judgement to identify and resolve complex site issues and deficiencies in documentation, communication, and the need for additional training.
• Assess and ensure overall integrity of study and adherence to guidelines, protocols, and regulations.
• Ensure compliance and understanding of study requirements by site staff.
• Interpret data to identify protocol deviations or major risks to data integrity.
• Understand project scope, budgets, and timelines and be able to provide input and manage project objectives to meet timelines.
• Act as a liaison between the company and study site personnel and be able to respond to site concerns and questions.
• Review and verify case report forms and other clinical data for completeness and accuracy.
• Monitor patient safety and identify and address any protocol deviations and make appropriate recommendations.
• Generate queries and manage resolutions with site staff.
• Maintain project tracking systems as required.
• Participate in the identification and selection of investigators and clinical sites.
• Maintain working knowledge of GCP/ICH Guidelines as well as applicable regulations.

Experience Required:
• More than 2 years experience/ proven track record in in-house support and monitoring
• More than 2 years prior clinical monitoring experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Strong organizational skills
• Must demonstrate good computer skills.
• Excellent communication, presentation, interpersonal skills, both written and spoken, both in Greek and English language.

Compensation & Benefits Overview:
• A competitive remuneration package with excellent benefits.
• A commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization.
• The opportunity to work within a successful and rewarding environment.