Clinical Research Associate, Site Management - Italy

About the role

iQVIA is looking for a Clinical Research Associate to perform site monitoring and site management work in Italy. The role ensures that sites carry out the study(s) and report study data as required by the protocol, applicable regulations and 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 GCP and ICH guidelines.
• Work with sites to adapt, drive and track the subject recruitment plan so that it matches project needs.
• Administer protocol and study training, set up regular communication 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, ICH and local requirements.
• Create documentation on monitoring visits and action plans through visit reports, follow-up letters and other study documents.
• Liaise with study team members; may also support site recruitment planning and site financial management and invoice retrieval where applicable.

Required profile

• Master's degree in Life Sciences.
• CRA certification according to ministerial requirements.
• Completion of a CRA training program or prior monitoring experience.
• Good therapeutic and protocol knowledge provided through company training.
• Written and verbal communication skills with a good command of English.

Required skills

• Basic knowledge of GCP and ICH guidelines and ability to apply them.
• 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.

The potential base pay range, annualized, is EUR 33,900 to EUR 61,700, depending on qualifications, location and schedule; incentives, bonuses and other benefits may also apply.