(Türkiye)

Responsibilities:

• Conduct site visits, including site selection, initiation, routine monitoring, and close-out visits, ensuring compliance with ICH-GCP, study protocols, and regulatory requirements.
• Monitor patient safety, data integrity, and protocol adherence, identifying and resolving issues proactively.
• Ensure that investigational sites maintain accurate study documentation and adhere to Good Documentation Practices (GDP).
• Work across sponsor-dedicated and multi-sponsor studies, managing multiple protocols and therapeutic areas.
• Provide training and support to site staff on study procedures and protocol compliance.
• Review and verify case report forms (CRFs) and electronic data capture (EDC) systems for data accuracy and completeness.
• Maintain effective communication with investigators, site staff, sponsors, and internal teams to ensure study timelines are met.
• Assist in the resolution of site-specific issues, queries, and deviations, escalating as necessary.
• Support in ethics submissions, regulatory documentation, and site feasibility assessments where required.
• Contribute to continuous process improvement and ensure adherence to SOPs and company policies.

Requirements:

• Minimum of 2 years’ independent monitoring experience in clinical research.
• Strong understanding of ICH-GCP, regulatory guidelines, and clinical trial operations.
• Experience in both sponsor-dedicated and multi-sponsor settings is preferred.
• Ability to manage multiple sites and protocols across different therapeutic areas.
• Excellent communication, problem-solving, and relationship-building skills.
• Ability to travel as required for site monitoring visits.
• Degree in Life Sciences, Pharmacy, Nursing, or a related field.