Senior Clinical Research Associate

Description:

Key Responsibilities:

• Execute and support remote and on-site visits. Site selection, initiation, interim monitoring and close out visits in accordance of SOPs.
• Main CRO contact for designated studies.+
• Develop a project management plan, project budget and study templates and study relevant tools required for the study.
• Ensure documents are complete and in line with ICH/GCP and any other applicable regulatory demands, whilst providing the relevant training to site staff.
• Add to the development of clinical protocols and relevant clinical forms.
• Assess monitoring visit reports and identifying or communicating trends to management.
• Be a mentor for CRAs.

Desired Background:

• 5+ years of Senior Clinical Research Associate Experience.
• Experience in oncology within the last 3 years.
• A life science or similar bachelor’s degree.
• Knowledge of clinical trial regulations such as GCP/ICH and FDA requirements.
• Open to high levels of travelling as needed.