Senior Clinical Research Associate (Clinical Research)

TL;DR

Senior Clinical Research Associate (Clinical Research): Managing and monitoring clinical trials for biotech and pharma companies with an accent on data integrity and patient safety. Focus on conducting site visits, maintaining TMF/eTMF documentation, and executing site start-up activities.

Location: Hybrid (Turkey)

Company

A leading Contract Research Organization (CRO) helping biotech, medtech, and specialty pharma companies transform breakthrough science into new medicines and devices.

What you will do

• Deliver quality, timely monitoring reports for sponsor approval according to Clinical Monitoring Plan timelines.
• Conduct on-site qualification, study initiation, interim, and close-out monitoring visits at investigator sites.
• Ensure data integrity and patient safety in accordance with specific country regulations.
• Maintain Trial Master File (TMF) and electronic TMF (eTMF) following ICH/GCP Section 8 guidelines.
• Plan daily monitoring activities and set priorities across assigned sites.
• Manage site start-up activities and local submissions (comprising 50% of the role).

Requirements

• Undergraduate degree in a clinical, science, or health-related field, or equivalent professional license (e.g., registered nurse).
• At least 4+ years of independent monitoring experience.
• Successful completion of a CRA training program.
• Proven experience with study start-up activities and local regulatory submissions.
• Broad therapeutic experience, specifically in Oncology, Neuroscience, and Dermatology.
• Experience conducting trials across all phases, with a specific focus on Phases I & II.

Culture & Benefits

• Focus on professional growth with opportunities to acquire new skills and excel in the clinical research field.
• Flexible work-life balance to accommodate personal requirements.
• Collaborative environment where employee ideas and voice influence operational processes.
• Meaningful work contributing to the delivery of critical medical innovations for patients.