Lensa
Clinical Research Associate (CRA) - All Levels
Summary
Thermo Fisher Scientific (PPD clinical research services) is hiring Clinical Research Associates (CRA) at multiple levels to support end-to-end clinical trial operations. The role focuses on monitoring investigator sites, ensuring protocol/regulatory compliance, and maintaining audit readiness to protect subject safety and data integrity.
What you'll do
- 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 quality and accuracy via SDR/SDV and CRF review, and document monitoring activities in timely reports/letters.
- Review investigational product accountability through physical inventory checks and records review.
- Escalate deficiencies to clinical management and drive issues to resolution in collaboration with project team members.
- Maintain ongoing site communication between visits to confirm protocol adherence, timely data entry, and resolution of prior findings.
- Support investigator meetings and assist with identification/feasibility of qualified investigative sites when needed.
- Initiate sites per procedures and regulations; perform trial close-out activities and retrieval of trial materials.
- Ensure essential documents are complete and compliant with ICH-GCP and applicable regulations; conduct on-site file reviews per project specifications.
- Provide trial status tracking and progress updates; keep study systems (e.g., CTMS) complete, accurate, and up to date.
- Facilitate communication among sites, client, and internal teams; respond to audit/inspection and regulatory requirements.
- Complete administrative work (expense reports, timesheets) on time.
- Contribute to publications/tools and continuous process improvement initiatives.
Requirements
Education: Bachelor’s degree in a life science-related field (or equivalent combination of education/training/experience where applicable).
Experience: Clinical monitoring experience comparable to 2+ years of independent on-site monitoring as a clinical research monitor, or related clinical/health sciences experience with formal training in medical terminology and anatomy.
Regulatory knowledge: Proven understanding of ICH-GCP and EU/FDA requirements; ability to maintain working knowledge of applicable regulations and procedural documents.
Clinical knowledge: Medical/therapeutic area knowledge and medical terminology.
Skills: Critical thinking, problem-solving, root cause analysis, organization, time management, collaboration, and strong written/oral communication with medical personnel.
Technical: Proficiency with Microsoft Office and ability to learn study-related software/systems.
Language: Fluent in English and Turkish; strong English grammar.
Other: Valid driver’s license where applicable; must be based in Türkiye.
Conditions
Schedule: Standard (Mon–Fri).
Environment: Office; includes remote and on-site monitoring visits.
Location requirement: Must be based in Türkiye.
Compensation/benefits: Competitive salary (amount not specified) and extensive benefits package focused on health and well-being.
Work culture: Flexible working culture, work-life balance, collaborative team environment, and learning & development program.
Employer: Thermo Fisher Scientific (PPD clinical research services); equal opportunity employer.