Clinical Research Associate
Company: SoTalent Agency
- Location: Istanbul, Türkiye
- Seniority: Senior
- Employment type: Full-time
- Posted: 14 days ago
- Offer language: English
Job description
Clinical Research Associate (CRA) – Clinical Trial Monitoring
Location: Istanbul, Turkey
Employment Type: Full-time
Role Overview
An opportunity for an experienced Clinical Research Associate to support clinical trial delivery through site monitoring, site management and regulatory compliance. The role ensures clinical study sites meet protocol requirements, Good Clinical Practice (GCP), ICH guidelines and local regulatory standards while maintaining effective relationships with investigators, site staff and cross-functional study teams.
Key Responsibilities
- Conduct site selection, initiation, monitoring and close-out visits in line with study protocols, GCP/ICH guidelines and project requirements.
- Support site recruitment planning and track enrolment against study timelines.
- Train site personnel on study protocols, procedures and requirements.
- Monitor site performance, protocol compliance and data quality, escalating issues when necessary.
- Track regulatory submissions, approvals, patient enrolment, case report form (CRF) completion and data queries.
- Maintain Trial Master File (TMF) documentation and verify Investigator Site File (ISF) compliance.
- Prepare timely monitoring visit reports, follow-up letters and other required study documentation.
- Support study start-up activities and collaborate with cross-functional clinical operations teams.
- Assist with site-level financial management and recruitment planning where required.
Requirements
- Bachelor’s degree in a scientific or healthcare discipline, or equivalent experience.
- At least 1 year of on-site clinical trial monitoring experience.
- Good knowledge of GCP, ICH guidelines, clinical research processes and regulatory requirements.
- Proficiency in Microsoft Word, Excel, PowerPoint and digital tools.
- Strong written and verbal English communication skills.
- Excellent organisational, time-management and problem-solving abilities.
- Ability to build effective working relationships with clinical sites, sponsors and internal teams.
