Quality Assurance Specialist

Summary

Join Care Access as a Quality Assurance Specialist and oversee the Quality Department, monitoring quality and compliance of clinical work in traditional and decentralized trials. You will support the Director of Quality Assurance, ensuring high-quality clinical trial execution adhering to SOPs, GCP, and FDA/ICH guidelines. Responsibilities include administering and maintaining quality systems, ensuring data integrity and patient safety, implementing quality assurance standards, tracking audits, reviewing regulatory documents, addressing identified issues, maintaining SOPs, developing corrective action plans, supporting on-site audits, preparing reports, and executing the yearly audit plan. This remote position requires less than 10% travel. The ideal candidate possesses extensive experience in quality assurance and clinical research, along with strong communication, organizational, and computer skills.

Requirements

• Excellent working knowledge of medical and research terminology
• Excellent working knowledge of federal regulations and good clinical practices (GCP)
• Attention to detail
• Ability to communicate and work effectively with a diverse team of professionals
• Strong Organizational Skills: Able to prioritize, delegate, direct, support and evaluate others work and follow through on assignments
• Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients and vendors
• Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring a positive and supportive attitude to achieving these goals
• Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel Ability to balance tasks with competing priorities
• Demonstrate decision making skills Curiosity and passion to learn, innovate, able to communicate any possible risks and get things done
• Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
• High level of self-motivation and energy
• Ability to work independently in a fast-paced environment with minimal supervision
• Must have a client service mentality
• Experience with supporting multiple sites and identifying gaps
• Experience with internal and external audits: FDA, GCP, SOPs
• 2 years of experience in Quality Assurance
• 4 years of experience in Clinical Research

Responsibilities

• Provide support to the Quality Department through the administration and maintenance of quality systems, programs and processes
• Ensure high integrity of data and patient safety at the research site through quality assurance review
• Interpret and implement quality assurance standards and procedures
• Track quality assurance audits and other quality assurance activities
• Review study specific regulatory binders and documents to ensure all documents are appropriately completed, submitted and maintained per GCP standards
• Work with research staff and PI to ensure identified issues are addressed
• Review and maintain quality assurance SOPs and procedures
• Develop and track corrective action plans with recommendation and monitor follow up preventative actions as necessary
• Coordinate and support on-site audits conducted by external providers and regulatory agencies
• Prepare reports to communicate outcomes of quality activities
• Execute yearly audit plan
• Perform other duties as assigned

Benefits

• PTO/vacation days, sick days, holidays
• 100% paid medical, dental, and vision Insurance. 75% for dependents
• HSA plan
• Short-term disability, long-term disability, and life Insurance
• 401k retirement plan