Senior Clinical Research Associate (Remote)

About the Role

Our client is seeking an accomplished Senior Clinical Research Associate (CRA) to join their globally distributed team, supporting critical clinical trials remotely. This role is essential for ensuring the integrity, quality, and timely completion of clinical research studies. You will be responsible for monitoring study sites, ensuring compliance with protocols and regulatory requirements, and managing relationships with investigators and site staff, all from a remote capacity. This is an exceptional opportunity for an experienced CRA to take on a challenging and rewarding role within a leading pharmaceutical organization, contributing to the development of innovative new therapies without the need for a fixed office location.

Key Responsibilities

• Conduct remote and on-site monitoring visits (as needed) to ensure compliance with study protocols, GCP, and regulatory guidelines.
• Manage assigned clinical trial sites, ensuring timely data collection, query resolution, and patient safety reporting.
• Build and maintain strong working relationships with investigators, site staff, and study participants.
• Oversee study supplies, documentation, and regulatory binders for assigned sites.
• Prepare monitoring visit reports and communicate findings and action plans to study teams and management.
• Participate in site initiation, interim, and close-out visits, providing training and support to site personnel.

Requirements

• Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
• Minimum of 5 years of experience as a Clinical Research Associate in the pharmaceutical or biotechnology industry.
• In-depth knowledge of ICH-GCP guidelines and clinical trial regulatory requirements.
• Demonstrated experience in remote monitoring and site management.
• Excellent organizational, communication, and problem-solving skills.
• Ability to travel as required for site visits or investigator meetings.

Benefits

• Highly competitive salary, reflecting seniority and remote contribution.
• Comprehensive health, dental, and vision insurance plans.
• Retirement savings plan with employer contributions.
• Generous paid time off and opportunities for professional development.
• The significant flexibility of a fully remote position, supporting trials across various geographies.
• Opportunity to be part of groundbreaking medical research advancements from Stellenbosch and beyond.