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.
Qualifications and Skills:
- 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.
This role offers the opportunity to contribute to impactful clinical research in a dynamic and fast-paced environment.