Clinical Research Associate

Key Responsibilities:

• Oversee the initiation, monitoring, and closing of clinical trials in compliance with GCP, regulatory requirements, and study protocols.
• Perform on-site and remote monitoring visits to ensure adherence to the protocol, data integrity, and patient safety.
• Manage investigator sites, ensuring proper study conduct, regulatory compliance, and timely recruitment of participants.
• Conduct source data verification (SDV) and ensure accurate data collection and documentation.
• Assist in the preparation of study documentation, including case report forms (CRFs), monitoring plans, and site visit reports.
• Maintain effective communication with investigators, site staff, and study sponsors to address study-related issues.
• Ensure timely resolution of data queries and discrepancies in collaboration with the data management team.
• Provide training and support to site staff on study procedures, protocol requirements, and electronic data capture systems.
• Contribute to the submission and review of regulatory documents and ethics committee approvals.
• Collaborate with cross-functional teams to ensure the successful execution of clinical trials.

• Proven experience as a Clinical Research Associate in the pharmaceutical or CRO industry.
• In-depth knowledge of clinical trial processes, GCP, and local regulatory requirements.
• Strong organizational and time-management skills to handle multiple projects effectively.
• Excellent communication and interpersonal skills to liaise with investigators, site staff, and project teams.
• Ability to travel extensively within Turkey as required for site monitoring visits.
• Fluency in English and Turkish, both written and spoken.
• Degree in life sciences, pharmacy, or a related field.