**Description:** - Prepare and execute test plans and testing strategies. - Perform functional, integration, and user acceptance testing. - Design and implement automation testing. - Document and track defects and follow up on their resolution with development teams. - Work on highly complex systems and applications. - Improve quality processes and test automation. - Contribute to improving release quality

• Assess performance of internal, client or vendor case files or records • Identify trends and areas of opportunity for increased service efficiency and quality • Work in partnership with stakeholders to ensure all required and relevant data elements are accurately captured • Compile audit results and submit to manager for review • Provide audit results for quarterly stewardship reports • Monitor ongoing action items logs and project plans with appropriate stakeholders • Update vendor resources to mapping program

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.

• Execute manual and automated tests, track defects, verify requirements, and help ensure the quality and compliance of software products • Collaborate closely with developers, analysts, and cross-functional teams in a fast-paced environment • Contribute to the continuous improvement of QA processes and frameworks