What are the responsibilities and job description for the Quality Assurance Specialist position at Future Medical Research?
The Clinical Research Quality Assurance Specialist will be responsible for ensuring compliance with regulatory standards and Good Clinical Practice (GCP) guidelines across all clinical trials. This role involves monitoring, auditing, and maintaining the quality of clinical research processes, including data accuracy, patient safety, and regulatory adherence. The ideal candidate will work closely with the clinical team to identify and resolve issues and ensure that clinical trials are conducted with integrity and in alignment with FDA, ICH, and local regulatory requirements.
Key Responsibilities:
- Conduct routine internal audits of clinical trial processes and documentation to ensure compliance with regulatory standards (FDA, ICH-GCP).
- Review and approve clinical trial documentation, including informed consent forms, study protocols, and case report forms.
- Monitor the accuracy and completeness of clinical trial data and patient records.
- Collaborate with clinical teams to ensure adherence to study protocols and Good Clinical Practice (GCP).
- Develop and implement quality control procedures to ensure the integrity of clinical research data.
- Train clinical staff on regulatory compliance and quality assurance processes.
- Liaise with regulatory authorities and prepare for inspections and audits.
- Investigate and resolve deviations, non-compliance issues, and other quality-related concerns.
- Prepare reports and documentation related to clinical trial quality metrics.
- Ensure proper documentation of corrective and preventive actions (CAPA).
We are seeking a highly skilled Clinical Research Quality Assurance Specialist to join our growing team. If you are passionate about healthcare, clinical research, and ensuring the highest standards of quality and compliance, we want to hear from you!
Job Type: Full-time
Expected hours: 40 per week
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- Monday to Friday
Work Location: In person