GCP Specialist

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.

As a 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.

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.

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.

Work Environment / Physical Demands :
• 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

Why Capricor?
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.

Come Work With Us!
At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.

Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason.

Notice to Recruiting Agencies
Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.