Job Description

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 into 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.

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How This Role Makes a Difference

The Senior Manager, Quality Assurance oversees the activities of the Quality Assurance function and reporting staff. This role is responsible for ensuring that our clinical research activities conform to regulatory requirements, industry best practice, company policies and procedures, with and in support of the Quality Assurance Management team, to ensure that Care Access maintains a high level of quality.



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How You'll Make An Impact

Oversee the daily workflow and schedules of the department. Provide coaching and supervision to QA team, training and onboarding new staff, and ensuring team members are performing to standard of their role. Serve as the GCP lead by providing high standard of quality guidance, advice and support on GCP compliance. Manage and maintain databases for the quality systems and provide quarterly reports and quality metrics to Head of Quality Assurance. Prepare reports to track and communicate outcomes of quality assurance activities. Creation and tracking of the internal audit program for clinical research sites, departments, processes and vendors. Oversee and participate in its execution, peer review staff audit reports, ensuring effectiveness and compliance with regulatory requirements, company policies, and procedures. Manage, co/host and participate in preparation and execution of client audits and regulatory authority inspections. Collaborate with other departments and stakeholders to ensure that quality issues are addressed in a timely and effective manner. Coach and train operational staff on quality processes, including but not limited to reporting of quality issues, root cause analysis, CAPA development. Develop and implement policies and procedures for quality assurance activities. Review, and revision of quality assurance SOPs and procedures. ###

The Expertise Required

Excellent working knowledge of medical and research terminology Excellent working knowledge of applicable 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 verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors. 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 databases, IXRS systems, delectronic data capture, MS word and exce Ability to balance tasks with competing priorities Demonstrate effective decision making skills 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 A customer/client centric service mentality

Certifications/Licenses, Education, and Experience:

Bachelor's Degree or equivalent research experience A minimum of 8 yrs experience in clinical research, with a minimum of 5 yrs of experience in quality assurance within a site management, CRO or Pharma organization or equivalent environment Experience of performing different type of quality audits e.g., investigator site audits, vendor audits, process audits Experience of regulatory inspections e.g. FDA, EMA Experience of sponsor/CRO audit process Direct line management experience will be an asset ###

How We Work Together

Location

: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.

Travel

: This role requires up to 25% International travel requirements. Length of travel will depend upon study requirements, staff needs, and company initiatives.

Physical demands associated with this position Include

: The ability to use keyboards and other computer equipment.
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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

Diversity & Inclusion

We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.



We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.



Care Access is unable to sponsor work visas at this time.



If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com