Care Access
Specialist, Quality Assurance
Remote role where the employee must remain based in a particular country.
United States only
Employer listed it 2 days ago · Added 5 days ago
First listed 5 days ago and still open.
Salary
$70k to $90k per year
Location
United States only
Timezone
US East
Contract
Full-time
Experience
Mid
Category
Other
Stated by the employer in the job description
Remote flexibility
Work from home
This is a remote role, but the employee must be based in United States. It is work from home rather than work from anywhere.
What the employer says
- Source listing states candidate location: "USA Remote"
What Nomaders makes of it
- Residency required in United States
- Payroll and tax are likely handled in that country only
The quotes above are the employer's own words; the reading is ours. Always check the original listing and employment terms before working from another country.
About the role
About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit www.CareAccess.com .
How This Role Makes a Difference
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. The Quality Assurance Specialist will be responsible for closely monitoring the quality and compliance of clinical work at both traditional trial sites and decentralized trials. The QA specialist will directly support quality initiatives, audit functions, CAPA systems and promote inspections readiness. Working in support of the Associate Director of Quality Assurance, the Quality Assurance Specialist will ensure that Care Access maintains a high level of quality while executing clinical trials according to Care Access SOPs, GCP, and FDA/ICH Guidelines.
How You'll Make An Impact
Site-Level Quality & Data Integrity: 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.
GCP Regulatory Document Review: Conduct comprehensive reviews of study-specific regulatory binders and clinical documents to verify they are accurately completed, submitted, and maintained per GCP standards.
Audit Execution & Tracking: Execute the yearly corporate audit plan, systematically tracking quality assurance audits, monitoring related activities, and preparing detailed outcome reports for management.
Issue Resolution & CAPA 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.
External Audit & Inspection Support: Coordinate and provide hands-on operational support for on-site audits and inspections conducted by external providers, sponsors, and regulatory agencies.
Quality Systems Administration: Provide ongoing administrative support to the Quality Department by maintaining internal quality systems, compliance trackers, and operational programs.
SOP Development & Maintenance: Participate in the routine review, drafting, and maintenance of quality assurance Standard Operating Procedures (SOPs) to ensure alignment with evolving regulations.
Cross-Functional Compliance Advisory: Act as an internal quality resource to provide ongoing guidance and best-practice recommendations to site personnel and clinical project teams.
Regulatory compliance: be knowledgeable of evolving GxP guidelines. Ability to critically think, eagerness to learn, and commitment to ensuring compliance. Knowledge of and able to interpret regulatory guidance’s such as 21 CFR Part 11/ Part 312, ICH GCP E6 (R3).
Inspection readiness: promote a culture of inspections readiness and continuous improvement. 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)
Willingness to learn and engage with digital technologies
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
The Expertise Required
Requirements
The employer hasn't listed requirements separately, they're described in the role summary above and on the original listing.
Benefits
- ·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
How to apply
- 1Check the flexibility label above, work from home, matches where you plan to live and work.
- 2Tailor your CV to the role at Care Access, mentioning your remote working experience and working hours (US East).
- 3Apply directly on the employer's careers page using the button below. Nomaders never handles your application.
Found 5d ago. Last checked 23 Sept. Always confirm the details on the original posting, salary and location can change after publication.
Listing sourced from Company boards.
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