QUALIFICATIONS AND JOB DESCRIPTION

Job Description

• Perform site selection, qualification activities, provide evidence of investigators’ qualification and recommendations on additional training required,
• Participate in preparation of clinical trial agreements,
• Provide qualification, initiation, monitoring and close-out visits,
• Participate in organization of investigator meetings, presenting protocol or other relevant study topics, materials, logistics if required,
• Create, collect and maintain clinical trial documentation,
• Assist in selection of the vendors (laboratory, warehouse, broker, courier, etc.) needed for organization of the clinical trial,
• Perform and track Ethics Committees and Health Ministree submissions,notifications and replies,
• Assess the recruitment rate against projected. Track of patients’ status at each site during the study,
• Coordinate investigational product and non-drug supplies import/export and distribution between sites,
• Ensure appropriate storage of investigational product, study supplies and biologic samples at sites,
• Ensure strong communication with sites, identify, resolve or escalate issues. Keep management informed about progress and compliance of the study,
• Track of study expences and timely preparation of financial reports,
• Review the translations of documents related to the study, adjust global ICFs to the country format.

General Qualification

• Bachelor’s or Master’s Degree (or equivalent) in life science, medical, pharmacy or related field,
• Strong knowledge of GCP and local regulatory requirements,
• Minimum 2 year of experience as a CRA,
• Strong organizational and communication skills,
• Advanced English ( (verbal and written).