Job Title : Clinical QA Specialist
Job Summary:
The Clinical QA Specialist ensures the quality and compliance of clinical trials with regulatory standards. This role monitors trial processes, identifies deviations, and ensures data integrity and patient safety.
Roles and Responsibilities:
- Oversee clinical trial processes to ensure compliance with Good Clinical Practice (GCP) guidelines.
- Conduct on-site and remote audits of clinical trial facilities.
- Review trial protocols, investigator brochures, and other study documentation.
- Ensure proper documentation and archiving of clinical data.
- Monitor adherence to ethical standards and regulatory requirements in clinical research.
- Collaborate with sponsors, investigators, and regulatory bodies to resolve quality issues.
Qualifications Required:
- Bachelor’s/Master’s degree in Clinical Research, Life Sciences, or related field.
- 3+ years of experience in clinical quality assurance.
Skills Required:
- In-depth understanding of GCP and clinical trial regulations.
- Excellent analytical and attention-to-detail skills.
- Strong interpersonal and communication skills to collaborate with stakeholders.
- Ability to handle confidential information securely.
Benefits-
- Competitive salary
- Annual appraisal and bonuses
- Rewards and Recognition
- Performance based bonuses
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