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
- 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 driver's license and willingness to travel to clinical trial sites
This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.