Senior Clinical Research Associate

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

📋 Description

• Operate as a key member of a Project Team

• Initiate, oversee on-site and remote activities, and finalize clinical trial study sites

• Conduct monitoring of clinical trials in accordance with company and sponsor SOPs, GCP, ICH guidelines, and relevant regulations

• Execute monitoring tasks to ensure participant safety, data integrity, and overall quality

• Confirm informed consent processes and adherence to protocols

• Evaluate electronic or paper CRFs and source documents for validity and precision

• Ensure management and accountability of investigational products

• Generate Monitoring Visit Reports, document findings along with corrective/preventive actions, update tracking systems, and escalate issues as necessary

• Communicate identified issues and required action items to study sites

• Deliver site documents to eTMF or paper TMF and verify the maintenance of the Investigator Site File

• Engage in audit and inspection preparation and follow-up activities

• Order, ship, and reconcile clinical investigative supplies when necessary

• Update CTMS and other project systems with precise site-level information

⛳️ Requirements

• Bachelor’s Degree, ideally in life sciences or nursing; or equivalent experience

• Minimum of 3 years of experience in monitoring clinical trials in Oncology, including at least one early-phase study (Phase I or II)

• Familiarity with basic medical terminology and the science related to assigned drugs and therapeutic areas

• Knowledge of Good Clinical Practice regulations and ICH guidelines

• Capability to work autonomously as well as within a team matrix organization

• Excellent written and verbal communication abilities

• Proficient in English

• Strong organizational skills

• Technology-savvy with proficient software and computer skills

• Willingness and ability to travel up to 60–80%, including overnight and international travel when required

🏝️ Benefits

• Competitive compensation package

• Comprehensive benefits

• Opportunities for personal and professional development

• Lunch vouchers

• Health insurance

• Pension plan

• Car allowance where applicable

• Collaborative and innovative work environment