Senior Clinical Research Associate

Chloe O'Shea is proud to partner with a leading global CRO providing innovative clinical trial solutions. We are seeking an experienced Clinical Research Associate (CRA) to join a dedicated team based in Romania for a single-sponsor opportunity. This role offers a manageable workload of 5-8 site visits per month, allowing you to focus on high-quality monitoring and site management.

The Role

As a Clinical Research Associate (CRA), you will play a key role in driving the success of clinical trials across Romania. Collaborating with the sponsor and investigative sites, you will ensure compliance with protocols, GCP guidelines, and regulatory requirements. With a focus on building strong site relationships, this position is ideal for professionals passionate about advancing clinical research in a supportive and innovative environment.

Key Responsibilities

• Perform site qualification, initiation, routine monitoring, and close-out visits across Turkey.
• Ensure clinical sites adhere to ICH-GCP guidelines, applicable regulations, and protocol-specific requirements.
• Verify the accuracy and integrity of clinical data and oversee the management of investigational products (IP).
• Identify, resolve, and escalate site-related issues to ensure timely and efficient trial progress.
• Foster and maintain strong professional relationships with site staff and sponsor representatives.
• Provide training and guidance to site staff to ensure protocol compliance and study quality.
• Maintain essential trial documentation and update systems such as CTMS, eTMF, and EDC.

Requirements

• A Bachelor’s degree in a health or life sciences discipline.
• At least 2 years of independent monitoring experience as a CRA
• Strong knowledge of ICH-GCP guidelines and Romanian regulatory requirements.
• Experience in conducting site visits and monitoring activities across multiple therapeutic areas.
• Fluent in Romanian and English, both written and spoken.
• Strong organizational skills and ability to manage priorities effectively.

What’s in It for You?

• Competitive salary with additional benefits.
• Opportunities for career growth within a global organization.
• Flexible working environment with manageable travel requirements.
• Exposure to innovative technologies and methodologies in clinical research.
• Comprehensive health benefits and wellness programs.

If you are a motivated professional looking to advance your career as a Clinical Research Associate, we would love to hear from you. Apply now and join a team dedicated to driving innovation in clinical trials!