Experienced CRA, Sponsor Dedicated - Italy

About the role

iQVIA is looking for an experienced Clinical Research Associate (CRA) dedicated to a sponsor, based in Milan, Italy. The role covers monitoring and site management so that sites carry out studies and report data in line with the protocol, regulations, guidelines and sponsor requirements.

Key responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) under the contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive and track the subject recruitment plan to improve predictability.
• 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 on site management and monitoring visits, including visit reports and follow-up letters.
• Liaise with the study team; may also support site recruitment plans and site financial management and invoice retrieval.

Required profile

• Bachelor's or Master's degree in a scientific discipline or health care.
• At least 3 years of on-site monitoring experience.
• CRA certification according to the Ministerial Decree of 15 November 2011.
• Good knowledge of clinical research regulations, including GCP and ICH guidelines.
• Good command of English, written and verbal.

Required skills

• Proficiency in 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.

The potential base pay range is EUR 33,900 to EUR 66,700 per year, depending on qualifications, location and schedule; incentives, bonuses and other benefits may also apply.