GCP Specialist

Capricor Therapeutics is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. As a GCP Specialist, you will support GCP compliance for clinical operations to ensure regulatory adherence.

Requirements

• Bachelor’s degree in a scientific or related discipline, or 5 years of equivalent experience.
• 3-5 years of eTMF experience, including study start-up, maintenance, and quality reviews.
• 3+ years of experience in pharmaceutical industry roles related to clinical trials (e.g., clinical operations, project management).
• Experience in quality assurance or quality management activities.
• GCP Specialist • Experience with GCP vendor and site audits preferred.
• Ability to manage projects and tasks in a fast-paced environment.
• Analytical and critical thinking skills for quality review decision-making.
• Knowledge of pharmaceutical industry standards, including ICH/GCP guidelines.
• Experience with BIMO inspections preferred; EMA/MHRA/PDMA experience a plus.
• Communication skills, both verbal and written.
• Leadership and problem-solving skills.
• Ability to translate strategy into operations and manage multiple priorities.
• Ability to work independently with limited supervision.

Benefits

• $109,000 - $117,500 a year