Clinical Research Associate (CRA) - All Levels

Thermo Fisher Scientific (PPD Clinical Research Services) is seeking a Clinical Research Associate (CRA) across all levels to support global clinical trials and ensure high-quality, compliant study execution. The role focuses on monitoring and site management to protect subject safety and ensure data integrity in line with ICH-GCP and applicable regulations.

• Perform remote and on-site monitoring visits using a risk-based monitoring approach, including root cause analysis and corrective/preventive action follow-up.
• Ensure data accuracy through SDR/SDV and CRF review; assess investigational product via inventory and records review.
• Document monitoring observations in reports and follow-up letters; escalate issues to clinical management and drive resolution to closure.
• Maintain regular communication with sites between visits to confirm protocol adherence, issue resolution, and timely data entry.
• Support investigator meetings; help identify and qualify potential investigative sites with the client as needed.
• Initiate sites per procedures to ensure protocol and regulatory compliance; conduct trial close-out and retrieve trial materials.
• Ensure essential documents are complete and compliant with ICH-GCP and regulations; perform on-site file reviews per project specifications.
• Provide trial status tracking and progress updates; keep study systems (e.g., CTMS) complete, accurate, and current.
• Facilitate communication among sites, clients, and internal teams; support audits, inspections, and regulatory/client requirements.
• Complete administrative work such as expense reports and timesheets on time; contribute to project tools, publications, and process improvement initiatives.

• Education: Bachelor’s degree in a life science-related field (or acceptable equivalency combining education/training/experience).

• Experience: Clinical monitoring experience comparable to 2+ years of independent on-site monitoring (or related clinical/health sciences experience with formal training in medical terminology and anatomy may be considered).

• Regulatory knowledge: Proven understanding of ICH-GCP, EU and FDA requirements; ability to maintain working knowledge of applicable regulations and procedural documents.

• Clinical knowledge: Medical/therapeutic area knowledge and strong medical terminology understanding.

• Skills: Critical thinking, problem solving, root cause analysis, risk-based monitoring concepts, strong organization and time management, customer focus, attention to detail, and ability to work independently or in a team.

• Communication: Strong oral and written communication skills; able to communicate effectively with medical personnel.

• Tools: Solid Microsoft Office skills and ability to learn study software (e.g., CTMS).

• Languages: Fluent in English and Turkish.

• Other: Valid driver’s license where applicable; must be based in Türkiye.

• Schedule: Standard (Mon–Fri).

• Environment: Office; includes remote and on-site monitoring visits.

• Location requirement: Must be based in Türkiye.

• Compensation/benefits: Competitive salary and extensive benefits package focused on health and well-being; flexible working culture; learning and development program.