Senior Clinical Research Associate, Local Start-Up Specialist

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

📋 Description

• Take full responsibility for overseeing all facets of monitoring for designated clinical trials throughout various study phases, which includes site initiation, routine monitoring, and close-out visits.

• Ensure adherence to protocols, Good Clinical Practice (GCP), International Council for Harmonisation (ICH), Standard Operating Procedures (SOPs), and relevant regulatory standards.

• Develop strong relationships with sites and serve as the primary point of contact.

• Guarantee the collection of high-quality data.

• Identify and address site-related issues, escalating them as necessary to uphold trial integrity and safeguard patient safety.

• Conduct activities related to regulatory affairs, site activation, and study initiation.

• Travel extensively within Ukraine.

⛳️ Requirements

• A minimum of 5 years’ experience in leading monitoring activities for complex trials.

• Ideally, experience in oncology or rare disease trials.

• A strong grasp of ICH-GCP and regulatory guidelines.

• Ability to communicate clearly and confidently in both English and the local language.

• Capacity to work independently while managing multiple priorities.

• Willingness to travel as needed.

🏝️ Benefits

• Meaningful partnerships with clients.

• Collaboration with leading experts across science, business, and operations.

• Opportunities to advance pharmaceuticals and biologics.

• Chance to contribute to life-changing treatments and enhance patient lives.