Capricor Therapeutics, Inc. · 23 hours ago
GCP Specialist
San Diego, CA
Full-time
Onsite
Mid Level
$109K/yr - $118K/yr
3+ years expCapricor Therapeutics is a biotechnology company focused on advancing innovative therapies for rare diseases. The GCP Specialist will support GCP compliance for clinical operations, ensuring regulatory adherence and collaborating with cross-functional teams to maintain clinical trial integrity.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
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
Site SIMO
Sponsor BIMO
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
Qualification
Required
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
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
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
Preferred
Experience with GCP vendor and site audits
Experience with BIMO inspections; EMA/MHRA/PDMA experience a plus
Company
Capricor Therapeutics, Inc.
Capricor Therapeutics is a publicly traded (NASDAQ: CAPR) biotechnology company with a mission to develop groundbreaking therapies that make a meaningful impact on patients’ lives.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$329.5MKey Investors
Nippon ShinyakuNational Institutes of HealthCalifornia Institute for Regenerative Medicine
2025-12-05Post Ipo Equity· $150M
2024-10-17Post Ipo Equity· $75M
2024-09-17Post Ipo Equity· $15M
Leadership Team
AJ Bergmann
Chief Financial Officer
Recent News
2026-01-09
Company data provided by crunchbase