Clinical Research Associate

About the role

IQVIA, a global provider of clinical research services, is looking for a Clinical Research Associate in Sofia. The role performs monitoring and site management work so that study sites carry out the study correctly and report data as required by the protocol, regulations, guidelines and sponsor requirements.

Key responsibilities

• Carry out site monitoring visits (selection, initiation, monitoring and close-out) following the contracted scope of work and GCP and ICH guidelines
• Work with sites to adapt, drive and track the subject recruitment plan to make it more predictable
• Deliver protocol and study training to sites and keep regular contact to manage project expectations and issues
• Evaluate the quality and integrity of site practices, escalate quality issues and track regulatory submissions, recruitment, CRF completion and data queries
• Ensure site documents are available for the Trial Master File and that the Investigator's Site File is kept according to GCP and local rules
• Document monitoring visit findings and action plans through regular visit reports and follow-up letters
• Liaise with the study team; may support the start-up phase, develop site-level recruitment plans and handle site financial management and invoice retrieval where applicable

Required profile

• Native Bulgarian and English
• Bachelor's degree in a scientific discipline or health care preferred; equivalent education, training and experience may be accepted
• At least 1 year of on-site monitoring experience
• Good knowledge of GCP and ICH guidelines, and good therapeutic and protocol knowledge from company training
• Organizational, problem-solving, time and financial management skills, and ability to build working relationships with colleagues, managers and clients

Required skills

• Microsoft Word, Excel and PowerPoint
• Use of a laptop, iPhone and iPad where applicable
• Written and verbal communication in English