Clinical Research Associate, Senior CRA

This is a fully remote position, open to applicants in Ukraine.

📋 Description

• Prepare, execute, and report on various types of monitoring visits, including site selection, initiation, routine monitoring, and close-out visits.

• Ensure adherence to study protocols, ICH-GCP guidelines, and regulatory standards.

• Establish and nurture robust relationships with investigators and site personnel.

• Monitor patient recruitment, study schedules, and site performance metrics.

• Conduct source data verification, address data queries, and manage risks at the site level.

• Oversee the accountability of investigational products, trial supplies, and essential study documentation.

• Maintain Investigator Site Files (ISF) and assist in the reconciliation of the Trial Master File (TMF).

• Provide study-specific training to investigators and site staff.

• Assist with regulatory submissions, audit preparations, and the resolution of audit findings.

⛳️ Requirements

• MD, PharmD, or MSc degree.

• A minimum of 1 year of independent on-site monitoring experience in Ukraine.

• Experience with all types of monitoring visits in Phase II and/or III studies.

• Background in Oncology/Ulcerative Colitis/Antibiotics trials is advantageous.

• Full working proficiency in both English and Ukrainian.

• Proficiency in MS Office applications.

• Ability to plan, multitask, and thrive in a dynamic team environment.

• Strong communication, collaboration, and problem-solving capabilities.

• Willingness to travel as needed.

🏝️ Benefits

• Opportunity to enhance skills and professional development.

• Expand experience across various therapeutic areas.

• Become a specialist in clinical research.