GCP Specialist

1 month ago
Full-time
Mid Level
Quality Assurance and Testing
Capricor Therapeutics

Capricor Therapeutics

Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a clinical stage biotechnology company focused on the discovery, development and commercialization of first in class biological therapies for the treatment of cardiac and other serious medical conditions. I...

Pharmaceuticals
51-250
Founded 2005

Description

  • Develop, implement, and maintain systems and processes to ensure GCP compliance across clinical trials.
  • Provide GCP support to clinical study teams to identify and reduce compliance risks.
  • Collaborate with Quality Assurance, Regulatory Affairs, and Clinical teams to develop and maintain GCP-compliant policies and SOPs.
  • Oversee eTMF activities, perform compliance checks, and develop risk mitigation strategies for essential trial documentation.
  • Support inspection readiness activities, including BIMO/Sponsor/SIMO interactions and trial-specific training.
  • Assess and document clinical operations process deviations and manage related investigations.
  • Manage clinical CAPAs, conduct root cause investigations, and support change control and mitigation activities.
  • Review essential trial documents (e.g., protocols, informed consent forms, investigator brochures, DSURs, clinical study reports) for GCP adherence and quality.

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 pharmaceutical industry experience in roles related to clinical trials (e.g., clinical operations, project management).
  • Experience in quality assurance or quality management activities.
  • Experience with GCP vendor and site audits preferred.
  • Experience with BIMO inspections preferred; EMA/MHRA/PDMA experience a plus.
  • Knowledge of pharmaceutical industry standards, including ICH/GCP guidelines.
  • Strong analytical and critical thinking skills for quality review decision-making.
  • Effective verbal and written communication skills, with leadership and problem-solving abilities.
  • Ability to manage projects and multiple priorities in a fast-paced environment and to work independently with limited supervision.

Benefits

  • $109,000 - $117,500 annual salary range.
  • Listed as a remote, full-time (exempt) role with required on-site/clinical time for audits, training, and compliance activities.
  • Opportunity to work on late-stage cell and exosome therapy programs with patient-impact focus.
  • Collaborative, mission-driven environment that supports professional growth and innovation.

Interested in this position?

Apply directly on the company website

Apply Now

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