Sr Clinical Research Associate

About the role

The Clinical Research Associate will independently control and monitor investigational sites to ensure clinical studies are performed according to trial protocols and regulatory standards. This role acts as a bridge between the sponsor and the site, managing monitoring activities, site relationships, and study execution processes. The position supports small-medium biopharmaceutical companies in navigating clinical trials to bring new therapies to patients.

Responsibilities

• Independently manage all aspects of monitoring for assigned clinical trials across study phases, including site initiation, routine monitoring, and close-out visits.
• Ensure compliance with protocols, GCP, ICH, SOPs, and applicable regulatory requirements.
• Build strong site relationships, acting as a primary point of contact and ensuring high-quality data collection.
• Identify and resolve site issues, escalating as needed to maintain trial integrity and patient safety.
• Perform activities related to regulatory affairs, site activation, and study-startup.

Required skills

• Pharmaceuticals
• Product Development Operations
• ICH-GCP
• Regulatory guidelines
• Clinical monitoring

Nice to have

• Oncology
• Rare disease

Qualifications

• Minimum of 5 years of experience leading monitoring activities in complex trials

About the Company

Allucent is dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. The company focuses on forging meaningful partnerships with clients to turn groundbreaking ideas into treatments.