Clinical Research Associate II

This is a fully remote position, open to applicants in Italy.

📋 Description

• Oversee investigative sites throughout Italy

• Conduct site qualification, initiation, monitoring, and close-out visits

• Ensure compliance of clinical trials with study protocols, ICH-GCP, and relevant regulatory standards

• Safeguard patient safety, data integrity, and adherence to protocols

• Execute source data verification and assess study documentation

• Cultivate site relationships and offer continuous support to investigators and study personnel

• Assist with submissions to ethics committees and regulatory bodies when necessary

• Monitor accountability of investigational products and evaluate site performance

• Maintain documentation for the Trial Master File and aid in resolving queries

• Work collaboratively with cross-functional study teams to guarantee successful trial execution

⛳️ Requirements

• Degree in Life Sciences or equivalent qualifications

• Certified CRA training

• At least 4 years of experience in clinical research

• Minimum of 2 years' experience in monitoring as a CRA

• Comprehensive understanding of ICH-GCP, clinical trial regulations, and site management

• Proficient in Italian with a strong command of English

• Exceptional communication, organizational, and problem-solving abilities

• Capacity to work independently and handle multiple priorities

• Valid driver's license

• Willingness to travel up to 75%

🏝️ Benefits

• Flexibility to work from home

• Chance to engage in international clinical trials

• A collaborative and supportive team environment

• Competitive salary along with a comprehensive benefits package