Quality Assurance Specialist - Remote

Overview

Care Access is seeking a dedicated, experienced, and innovation-driven Quality Assurance Specialist to oversee the Quality Department, ensuring high levels of quality and compliance in clinical trials.

In Short

• Provide support to the Quality Department through quality systems and processes.
• Ensure data integrity and patient safety through quality assurance reviews.
• Implement quality assurance standards and procedures.
• Track quality assurance audits and activities.
• Review regulatory binders and documents for compliance.
• Collaborate with research staff to address identified issues.
• Maintain quality assurance SOPs and procedures.
• Develop and monitor corrective action plans.
• Support on-site audits by external providers and regulatory agencies.
• Prepare reports on quality activities.

Requirements

• 2 years of experience in Quality Assurance.
• 4 years of experience in Clinical Research.
• Excellent knowledge of medical and research terminology.
• Strong understanding of federal regulations and GCP.
• Attention to detail and strong organizational skills.
• Effective communication skills with diverse teams.
• Ability to work independently in a fast-paced environment.
• Experience with internal and external audits.
• Client service mentality and team collaboration skills.

Benefits

• PTO/vacation days, sick days, holidays.
• 100% paid medical, dental, and vision insurance.
• HSA plan.
• Short-term and long-term disability insurance.
• 401k retirement plan.
• Culture of growth and equality.