Clinical Research Associate - Sponsor-Dedicated

About the role

iQVIA is looking for an experienced Clinical Research Associate to work as a sponsor-dedicated CRA in Athens. The role covers monitoring and site management so that sites run their studies correctly and report data as required by the protocol, regulations, guidelines and sponsor requirements.

Key responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) according to the contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive and track the subject recruitment plan in line with project needs.
• Administer 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.
• Create documentation such as visit reports, follow-up letters and other study records.
• Liaise with study team members; may also support 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 2 years of on-site monitoring experience; an equivalent combination of education, training and experience may be accepted.
• Good knowledge of clinical research regulatory requirements, including GCP and ICH guidelines.
• Good therapeutic and protocol knowledge provided through company training.
• Written and verbal communication skills, including good command of Greek and English.

Required skills

• Microsoft Word, Excel and PowerPoint, and use of a laptop, iPhone and iPad where applicable.
• Organizational, problem-solving, time and financial management skills.
• Ability to build effective working relationships with coworkers, managers and clients.