Clinical Research Associate

Clinical Research Associate

ICON

Bucharest, Romania

As a Clinical Research Associate at ICON Plc, you will play a critical role in overseeing and managing one sponsor's clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle.

What You Will Be Doing

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards;
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution;
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting;
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct;
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Your Profile

• University degree in a relevant field such as life sciences, nursing or medicine;
• Min 8 months of experience in independent on-site monitoring of clinical trials (experience in SSVs, SIVs, IMVs, COVs);
• Strong understanding of clinical trial processes and local regulatory requirements;
• Willingness to travel 65% of the time;
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools;
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.