Clinical Research Associate (CRA)
TFS HealthScience · Tbilissi
Job description
About the role
TFS HealthScience is seeking a Clinical Research Associate to join its SRS/FSP team. The CRA will work with a global pharmaceutical sponsor, ensuring clinical studies are conducted safely, ethically, and in compliance with all regulations.
Key responsibilities
- Perform site monitoring visits, including selection, initiation, interim, and close‑out visits.
- Verify that investigator sites follow the study protocol, ICH‑GCP, sponsor requirements, and local regulations.
- Monitor patient safety, data quality, and study documentation throughout the trial lifecycle.
- Develop and maintain strong relationships with investigators, site staff, and sponsor stakeholders.
- Support site readiness, subject recruitment, and issue resolution to keep study timelines on track.
- Identify, document, and escalate risks while applying risk‑based monitoring approaches.
- Assist with audit and inspection readiness activities as needed.
Required profile
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum 3 years of independent clinical monitoring experience in the pharmaceutical, biotechnology, or CRO industry.
- Fluent written and spoken English.
- Willingness and ability to travel regularly within the assigned country and a valid driving licence.
Required skills
- Strong knowledge of ICH‑GCP guidelines and applicable regulatory requirements.
- Experience managing clinical sites from initiation through close‑out.
- Proficiency in clinical monitoring and site management processes.
What we offer
- Opportunities for personal and professional growth in a collaborative environment.
- Competitive salary aligned with local market conditions, plus applicable benefits.
- A culture built on trust, quality, passion, flexibility, and sustainability.
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Published 3 weeks ago
Expires 1 month from now
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TFS HealthScience
Tbilissi