Clinical Quality Assurance – GCP Specialist
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Job Description
Clinical Quality Assurance Specialist ensuring GCP compliance for clinical operations at Capricor Therapeutics. Collaborating with cross-functional teams to maintain clinical trial integrity.
Responsibilities:
- Support GCP compliance for clinical operations to ensure regulatory adherence.
- Assist in compliance processes and collaborate with cross functional teams to maintain clinical trial integrity.
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.
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