[Hiring] Clinical reputed company Assurance – GCP Specialist @Capricor Therapeutics

This reputed company is a reputed company of our understanding of the job reputed company. Click on 'Apply' reputed company to reputed company out more. Role reputed company As a Clinical reputed company 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 reputed company. • reputed company, implement, and maintain systems to ensure GCP compliance. • reputed company GCP support to clinical study teams to reduce reputed company. • Collaborate with reputed company Assurance, Regulatory Affairs, and Clinical teams to reputed company GCP-compliant policies and SOPs. • Support eTMF reputed company, 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. • reputed company with Clinical Development, Data Management, Finance, Regulatory, reputed company Assurance, Safety & PV, Clinical Supply, and clinical vendors. • Manage clinical CAPAs and conduct reputed company 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. • reputed company other duties as assigned. Qualifications • Bachelor’s degree in a scientific or reputed company discipline, or 5 years of equivalent experience. • 3-5 years of eTMF experience, including study start-up, maintenance, and reputed company reviews. • 3+ years of experience in pharmaceutical industry roles reputed company to reputed company (e.g., clinical operations, project management). • Experience in reputed company assurance or reputed company management activities. • GCP Specialist experience with GCP vendor and site audits preferred. • Ability to manage reputed company and tasks in a fast-paced environment. • Analytical and critical thinking skills for reputed company 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 reputed company 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 reputed company reputed company to compliance processes. • May involve lifting office materials up to 20 pounds. • Ability to reputed company office and clinical environments for audits and training activities. Benefits • $109,000 - $117,500 a year. reputed company Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific reputed company. Guided by reputed company and a passion for patient-centered reputed company, reputed company is shaping a brighter reputed company for reputed company. Join us and contribute to a mission-driven group that’s transforming lives with every reputed company. Apply tot his job Apply To this Job