[Hiring] Clinical Quality Assurance – GCP Specialist @Capricor Therapeutics

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description As a Clinical Quality Assurance – GCP Specialist, you will support GCP compliance for clinical operations to ensure regulatory adherence. You will assist in compliance processes and collaborate with cross-functional teams to maintain clinical trial integrity. • Develop, implement, and maintain systems to ensure GCP compliance. • Provide GCP support to clinical study teams to reduce compliance risks. • Collaborate with Quality Assurance, Regulatory Affairs, and Clinical teams to develop GCP-compliant policies and SOPs. • Support eTMF oversight, performing compliance checks and developing risk mitigation strategies. • Support inspection readiness activities and trial-specific training. • Assess and document Clinical Operations process deviations. • Collaborate with clinical trial teams to identify and improve operational processes. • Interact with Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Safety & PV, Clinical Supply, and clinical vendors. • Manage clinical CAPAs and conduct root cause investigations for deviations. • Support compliance assessment, mitigation, and change control processes. • Review essential documents (e.g., Clinical Protocols, Informed Consent Forms, Investigator’s Brochures, DSURs, Clinical Study Reports) for GCP adherence. • Perform other duties as assigned. Qualifications • 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. Requirements • Primarily office-based with required time in clinical trial settings addressing compliance and documentation. • Requires prolonged periods of computer use for data analysis, documentation, and report generation related to compliance processes. • May involve lifting office materials up to 20 pounds. • Ability to navigate office and clinical environments for audits and training activities. Benefits • $109,000 - $117,500 a year. Company Description Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.