Clinical Research Associate II Senior Clinical Research Associate

As a Clinical Research Associate II/ Senior Clinical Research Associate at PSI you will play a key role in ensuring the quality integrity and compliance of clinical trials across various therapeutic indications. You will act as the main point of communication between clinical trial sites and project teams building strong relationships with investigators and site staff while ensuring the rights safety and well-being of trial participants.

Hybrid role in Sofia Bulgaria

Your responsibilities will include:

• Preparing conducting and reporting on all types of monitoring visits including site selection initiation routine monitoring and close-out visits
• Ensuring compliance with study protocols ICH-GCP guidelines and regulatory requirements
• Building and maintaining strong relationships with investigators and site staff
• Monitoring patient recruitment study timelines and site performance
• Performing source data verification following up on data queries and managing site-level risks
• Overseeing investigational product accountability trial supplies and essential study documentation
• Maintaining Investigator Site Files (ISF) and supporting Trial Master File (TMF) reconciliation
• Delivering study-specific training to investigators and site staff
• Supporting regulatory submissions audit preparation and resolution of audit findings
• Providing guidance and mentoring to less experienced Clinical Research Associates

Qualifications :

• Degree in Life Sciences or a related field or an equivalent combination of education training and experience
• At least 1.5 years of independent on-site monitoring experience in Bulgaria ideally across multiple clinical trials
• Experience conducting all types of monitoring visits in Phase I II and/or III clinical trials
• C2 proficiency in Bulgarian and a good command of English both written and spoken
• Experience supporting oncology studies is an advantage but not essential
• Good knowledge of ICH-GCP guidelines and clinical trial regulations
• Proficiency in Microsoft Office applications
• Strong organizational communication and problem-solving skills
• Ability to work independently and collaboratively in an international team
• Valid drivers license and willingness to travel to clinical trial sites

Additional Information :

This is a great opportunity for you to further develop your skills widen your therapeutic area experience and become an expert in clinical research.

Remote Work :

No

Employment Type :

Full-time