Sr Clinical Research Associate

About the role

The Clinical Research Associate will independently manage and monitor investigational sites to ensure clinical studies are conducted according to trial protocols and regulatory standards. This role serves as the primary bridge between the sponsor and clinical sites, overseeing trial integrity and site relationships. The position involves managing monitoring activities, regulatory affairs, and site activation processes to support small-medium biopharmaceutical companies.

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
• Site management

Nice to have

• Oncology
• Rare disease

About the Company

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