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Specialist, Quality Assurance
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.
- 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
- 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
- Minimum Education:
- Bachelor's degree
- Minimum Experience:
- 2 years of experience in Quality Assurance
- 4 years of experience in Clinical Research working in a compliance or GCP relevant role
- Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.
- Travel: This is a remote position with up to 35% travel requirements. Must have the ability to travel. International travel may also be required as part of the role.
- Physical demands associated with this position Include: 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 (US Full Time Employees)- 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
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29-38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
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