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Clinical Research Associate II/ Senior Clinical Research Associate at PSI CRO | HealthRoleIQ

Opportunity

Clinical Research Associate II/ Senior Clinical Research Associate

PSI CRO·Sofia, Sofia City Province, Bulgaria

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About the role

Hybrid Clinical Research Associate II/Senior Clinical Research Associate role in Sofia, Bulgaria. Responsibilities include conducting and reporting monitoring visits, ensuring ICH-GCP and regulatory compliance, managing site performance and documentation, supporting submissions and audits, and mentoring CRAs. Requires a Life Sciences degree or equivalent education/training/experience, at least 1.5 years of independent on-site monitoring experience in Bulgaria, Bulgarian C2, English, clinical trial monitoring experience, and a valid driver's license.

Key requirements

• Degree in Life Sciences or a related field, or an equivalent combination of education, training, and experience
• At least 1.5 years of relevant experience
• Required skills: Independent on-site monitoring experience in Bulgaria, Conducting site selection, initiation, routine monitoring, and close-out visits, Experience in Phase I, II, and/or III clinical trials, Knowledge of ICH-GCP guidelines and clinical trial regulations, Microsoft Office proficiency, Organizational skills, Communication skills, Problem-solving skills, Ability to work independently and collaboratively, Willingness to travel to clinical trial sites
• Required languages: Bulgarian, English
• Professional registration/licence (Bulgaria)

Opportunity details

• Workplace: Hybrid
• Posted: Oct 16, 2026
• Original advert language: English

Full vacancy

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Employer’s role description

Job title: Clinical Research Associate II/ Senior Clinical Research Associate

Location: Sofia, Sofia City Province, Bulgaria

Employment type: Full-time

Workplace type: Hybrid

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

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 driver's 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.