We are looking for an experienced Senior CRA to strengthen our clinical operations in Bulgaria.
• Higher education (minimum bachelor’s degree) – preferred qualification in nursing, life sciences (biology, microbiology, toxicology, biochemistry, or pharmacology) or medical sciences (physiology, immunology, medicine, anatomy, or pharmacy)?
• Minimum 5 years of active monitoring experience
• Profound knowledge of clinical research processes and medical terminology
• Expert knowledge of ICH GCP, and international and local regulatory requirements
• Driving license B
• Passion for Clinical Research
• Ensure that Clinical Trial is conducted, recorded, and reported in accordance with all applicable international and local regulations and guidelines, good practices, SOPs and Clinical Trial Protocol.
• Ensuring data quality and integrity meet acceptable clinical standards and the rights and safety of patients involved in a study are protected.
• Perform and coordinate all aspects of the clinical monitoring and site management process.
• Conduct remote and on-site visits to assess protocol and regulatory compliance and manage required documentation.
• Develop collaborative relationships with investigational sites, act as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects rights, well-being, and data reliability; and you would ensure audit readiness.
• Serve as a facilitator of Clinical Trial conduct in the respective area in terms of identifying qualified sites and investigators, facilitating communication between Sponsor and regulatory authorities and trial sites.
• Apart from general CRA responsibilities, you would mentor and supervise less experienced colleagues (CRAs and CTAs) and ensure their professional development and quality of their performance.
What We Offer:
• Competitive salary
• Flexible working time and home-based working option
• Work-life balance (our CRAs are not overwhelmed with projects, we believe in quality over quantity)
• Friendly environment in a privately owned company, where we know each other and care for each other; yet an international experience, working with colleagues from different countries.
• Great opportunities for career growth; you would be able to explore various areas of the clinical research industry and develop your potential with us
• Other company benefits based on mutual agreement.