Clinical Research Associate - Sponsor Dedicated

About the role

iQVIA is looking for a sponsor-dedicated Clinical Research Associate in Athens. 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 assigned 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 regulations
• Document monitoring visit findings and action plans through regular visit reports and follow-up letters
• Liaise with study team members; may support the start-up phase, site recruitment plans and site financial management and invoice retrieval where applicable

Required profile

• High school diploma or equivalent; a degree in a scientific discipline or health care is preferred
• At least 1 year of on-site monitoring experience; an equivalent combination of education, training and experience may be accepted
• Good knowledge of GCP and ICH guidelines, and good therapeutic and protocol knowledge from company training
• Written and verbal communication skills, including good command of Greek and English
• Organizational, problem-solving, time and financial management skills, and ability to build working relationships with coworkers, managers and clients

Required skills

• Microsoft Word, Excel and PowerPoint
• Use of a laptop, and iPhone and iPad where applicable