Experienced Clinical Research Associate - Sponsor-Dedicated

About the role

iQVIA is looking for an experienced Clinical Research Associate to work sponsor-dedicated in Athens. The role covers monitoring and site management so that study sites carry out the study 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) in line with the contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive and track the subject recruitment plan to make it more predictable.
• Administer protocol and study training, keep regular contact with sites and escalate quality issues.
• Track regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, 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 action plans.
• Liaise with the study team; may also support site recruitment planning and site financial management and invoice retrieval.

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 mix of education, training and experience may be accepted.
• Good knowledge of clinical research regulations, including GCP and ICH guidelines.
• Good command of Greek and English, with strong written and verbal communication skills.
• Organized, problem-solving, and able to build effective working relationships with coworkers, managers and clients.

Required skills

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