TheClinical Quality Assurance Specialist (Clinical Testing/Clinical Trials) will report to the Laboratory Director. This individual will collaborate with Razor Genomics operations team and Razor Genomics Management to support clinical testing and clinical trials. The Clinical Quality Assurance Specialist (Clinical Testing/Clinical Trials) is a vital member of the Razor Genomics team responsible for ensuring adherence to quality standards, regulatory requirements, and best practices throughout the lifecycle of clinical testing and trials. This position requires a keen eye for detail, strong analytical skills, and a deep understanding of clinical testing, Clinical trial processes, and regulations. TheClinical Quality Assurance Specialist (Clinical Testing/Clinical Trials) works closely with cross-functional teams to support quality management initiatives, conduct audits, and drive continuous improvement efforts to enhance the overall quality and integrity of clinical testing and trial activities.

Responsibilities

• Assist in the development, implementation, and maintenance of quality management systems to ensure compliance with regulatory requirements, industry standards, and organizational policies.
• Participate in the development and review of standard operating procedures (SOPs), work instructions, and quality documents to promote consistency and compliance in clinical testing and trial operations.
• Conduct routine reviews and assessments of clinical testing and clinical trial documentation, data, and processes to identify areas for improvement and ensure accuracy and compliance.
• Stay informed about current regulatory guidelines and requirements from FDA, EMA, ICH, CLIA, CAP and other relevant regulatory authorities.
• Assist in the interpretation and implementation of regulatory requirements to ensure adherence to applicable laws and guidelines throughout the clinical testing and clinical trial process.
• Support regulatory inspections, audits, and inquiries by preparing documentation, facilitating site visits, and addressing findings as needed.
• Assist in developing training materials and resources on best practices for clinical testing and clinical trials.
• Participate in the delivery of training sessions to clinical testing and clinical trial staff to enhance their understanding of quality standards, regulatory requirements, and organizational policies.
• Provide guidance and support to clinical testing and clinical trial personnel on quality-related issues, procedures, and documentation requirements.
• Assist in the planning, execution, and follow-up of internal and external audits.
• Prepare audit plans, checklists, and reports to document audit findings, observations, and recommendations for corrective and preventive actions.
• Assist staff with process improvement needs identified through audits.
• Collaborate with stakeholders to track and monitor the implementation of corrective and preventive actions to address audit findings and ensure compliance with regulatory requirements.
• Maintain accurate and comprehensive documentation of quality assurance activities, audit findings, corrective actions, and preventive measures in accordance with established procedures and timelines.
• Prepare periodic reports and metrics to communicate the status of quality management activities, compliance initiatives, and audit outcomes to relevant stakeholders and management.

Key Competencies

• Demonstrated problem-solving and analytical capabilities.
• Solid understanding of Good Clinical Practice (GCP) guidelines, FDA regulations, and other applicable regulatory requirements governing clinical testing and trials.
• Solid understanding of CAP, CLIA, NYDOH, and other state agency regulations.
• Strong attention to detail, analytical skills, and problem-solving abilities.
• Excellent communication, interpersonal, and organizational skills.
• Ability to work independently and collaboratively in a fast-paced, team-oriented environment.
• Ability to work cross-functionally to deliver on key initiatives

Qualifications

• Minimum of 2-3 years of experience in clinical testing and trials, quality assurance, or regulatory affairs
• Bachelor’s degree in a relevant scientific discipline required
• Proficiency in Microsoft Office applications and familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS) preferred.
• Ability to travel ~25%

Job Type: Part-time

Pay: $40.00 - $50.00 per hour

Expected hours: 15 per week

Schedule:

• Day shift
• Monday to Friday

Experience:

• Clinical Quality Assurance: 1 year (Preferred)

Ability to Commute:

• Nashville, TN 37203 (Required)

Ability to Relocate:

• Nashville, TN 37203: Relocate before starting work (Required)

Work Location: In person