Lensa
Clinical Research Associate (CRA) - All Levels
Remote Middle $4.1k–$9.3k/moest.
Summary
Thermo Fisher Scientific (PPD clinical research services) is hiring Clinical Research Associates (all levels) to support end-to-end clinical trial operations globally. The role focuses on clinical monitoring and site management to ensure protocol/regulatory compliance, data quality, and audit readiness across various sponsor environments.
What you'll do
- Conduct remote and on-site monitoring visits using a risk-based monitoring approach, including root cause analysis, issue identification, and corrective/preventive actions.
- Ensure data accuracy through SDR/SDV and CRF review; assess investigational product via inventory and records review.
- Document findings in reports/letters, escalate deficiencies to clinical management, and drive issues through to resolution.
- Maintain regular communication with investigative sites between visits to confirm protocol adherence and timely data entry.
- Support site selection activities, attend investigator meetings as needed, perform site initiation, and execute trial close-out including retrieval of trial materials.
- Ensure essential documents are complete and filed per ICH-GCP and applicable regulations; perform on-site file reviews per project specifications.
- Provide trial status tracking and progress updates; keep study systems (e.g., CTMS) accurate and up to date.
- Facilitate communication between sites, clients, and internal teams; respond to regulatory requirements, audits, inspections.
- Complete administrative tasks such as expenses and timesheets; contribute to process improvement initiatives and project tools/publications.
Requirements
- Education: Bachelor’s degree in a life science-related field (or acceptable equivalency via education/training/experience).
- Experience: Clinical monitoring experience comparable to 2+ years independent on-site monitoring as a clinical research monitor (or relevant clinical/health sciences experience with formal training in medical terminology and anatomy may be considered).
- Proven understanding of ICH-GCP and applicable EU and FDA requirements.
- Understanding of medical/therapeutic area knowledge and medical terminology.
- Strong communication, collaboration, organizational, and time management skills; ability to work independently or within a team.
- Critical thinking and problem solving skills, including root cause analysis; ability to manage Risk-Based Monitoring concepts and processes.
- Computer skills including Microsoft Office and ability to learn study-related software/systems.
- Language: Fluent in English and Turkish.
- Valid driver’s license where applicable.
- Must be based in Türkiye.
Conditions
- Schedule: Standard (Mon–Fri).
- Environment: Office; remote and on-site monitoring travel expected.
- Location requirement: Based in Türkiye.
- Compensation/benefits: Competitive salary; extensive benefits package focused on health and well-being; flexible working culture and work-life balance; learning and development program.
- Employer: Thermo Fisher Scientific (PPD clinical research services); equal opportunity employer.