Clinical Research Associate II

As a Clinical Research Associate II 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

Employment type
Full-time

Work arrangement
Hybrid