Specialist, Quality Assurance

About the role

Care Access is seeking a dedicated, experienced, and innovation-driven Quality Assurance Specialist (GxP) to support the success of the Quality Assurance Department and organizational compliance activities.

Responsibilities

• Ensure the highest standards of patient safety and data integrity at clinical research sites through regular quality assurance reviews, interpreting and implementing standard QA procedures.
• Conduct comprehensive reviews of study-specific regulatory binders and clinical documents to verify they are accurately completed, submitted, and maintained per GCP standards.
• Execute the yearly corporate audit plan, systematically tracking quality assurance audits, monitoring related activities, and preparing detailed outcome reports for management.
• Partner directly with research staff and Principal Investigators (PIs) to resolve identified compliance issues, developing, tracking, and monitoring Corrective and Preventative Action (CAPA) plans.
• Care for coordination and provide hands-on operational support for on-site audits and inspections conducted by external providers, sponsors, and regulatory agencies.
• Provide ongoing administrative support to the Quality Department by maintaining internal quality systems, compliance trackers, and operational programs.
• Participate in the routine review, drafting, and maintenance of quality assurance Standard Operating Procedures (SOPs) to ensure alignment with evolving regulations.
• Act as an internal quality resource to provide ongoing guidance and best-practice recommendations to site personnel and clinical project teams.
• Be knowledgeable of evolving GxP guidelines. Be flexible to work with risk-based audit agendas and shifting priorities. Create and deliver training on Quality and Improvement activities.
• Support completion of RFP/RFI (Request for proposals/information).
• Provide AI project quality support and consultation.
• Support other activities related to the management of QMS and accuracy of data.
• Support GxP and non GxP quality issues and/or projects needing quality consultation and support.

Qualifications

• 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.
• Strong 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.
• The ability to use keyboards and other computer equipment.
• The expected pay range for this role is $70,000 - $90,000 USD per year for full time team members.

Benefits & Perks

• Paid Time Off (PTO) and Company Paid Holidays
• 100% Employer paid medical, dental, and vision insurance plan options
• Health Savings Account and Flexible Spending Accounts
• Bi-weekly HSA employer contribution
• Company paid Short-Term Disability and Long-Term Disability
• 401(k) Retirement Plan, with Company Match

Pay

$70,000 - $90,000 USD per year for full time team members.

Schedule

This is a remote position with up to 35% travel requirements. Must have the ability to travel.