Senior Clinical Research Associate – Temporary Contract

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

📋 Description

• Ensure the proper execution of clinical trials in accordance with the Study Monitoring Plan, relevant regulations, GCP, and client standards.

• Oversee the operational elements of clinical trial activities at designated investigator sites from the activation phase through to database lock.

• Act as the primary contact for assigned investigator sites.

• Collaborate with or escalate issues to the Study Clinical Project team to guarantee quality delivery at the site level.

• Participate in investigator meetings as necessary, either virtually or in person.

• Provide support for enrollment and tackle issues related to site activation and recruitment.

• Conduct both onsite and remote/electronic monitoring for site initiation, routine oversight, and site closure.

• Track site-level adverse events and serious adverse events, working closely with the Drug Safety Unit and investigators.

• Submit requisite reports, documentation, and updates, including TMF documentation, site reports, follow-up letters, protocol deviations, recruitment statistics, clinical supply management, study progress, and metrics.

• Identify and resolve issues at investigator sites and implement corrective and preventive measures.

• Address data queries and prepare for, as well as conduct, investigator site close-out activities.

⛳️ Requirements

• At least 3 years of relevant experience in clinical research site monitoring.

• Ideally, 2 years of experience in Oncology.

• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.

• Experience in global clinical trials.

• Proficient in English.

• Willingness to travel extensively throughout Turkey.

• A valid driver’s license and passport are required.

• Thorough understanding of clinical trial methodologies, ICH/GCP, FDA, and local regulations.

• Proven knowledge of clinical research and development processes.

• Familiarity with global and local regulatory requirements.

• Comprehensive understanding of monitoring, data acquisition and cleaning, reporting, and other essential operational aspects of clinical research.

• In-depth knowledge of disease and technical areas relevant to clinical studies.

• Proven ability to support sponsor regulatory interactions and inspections.

• Familiarity with protocol design and feasibility assessment processes.

• Awareness of regional/country culture and medical practices affecting clinical trial delivery.

• Ability to evaluate, interpret, and present complex issues and data to facilitate risk management and mitigation.

• Bachelor’s degree in life sciences or a professional degree in life sciences, such as nursing, pharmacy, or a medical background, or equivalent experience.

🏝️ Benefits

• Temporary contract.

• Full-time employment.