Job Description
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.
How This Role Makes a Difference
The Quality Systems Manager is responsible for leading eQMS system design, implementation, system administration and ongoing maintenance. This role also provides support to the Quality Assurance Department through closely overseeing the quality and compliance of clinical work throughout the Company to ensure all systems and procedures undertaken are compliant with Care Access SOPs, study protocols, ICH-GCP Guidelines, and other applicable regulatory requirements. With and in support of Quality Assurance Management, will coordinate and participate in specific projects and conduct activities in collaboration with other QA members.
How You'll Make An Impact
- Quality System Management
- With input from key stakeholders, determine optimal workflow and configuration specifics related to electronic document management and related training, quality issues, CAPAs, audit issues and management, and reporting across all modules.
- Lead the eQMS system design, implementation, system administration and ongoing maintenance.
- Act as the eQMS primary system administrator, and lead for ongoing system management and maintenance.
- Provide support to the Quality Department through the creation, administration and maintenance of quality systems, trackers, programs and processes.
- Overall Quality Support
- Track and report on quality assurance activities and metrics
- Conduct reviews of Care Access procedures, as required, to ensure alignment with quality standards and regulatory requirements.
- Work with other Care Access Departments to assist and provide guidance and support from a quality perspective.
- Investigate, analyze, and ensure the accuracy of information in quality data collection tools, contributing to reliable data-driven decision-making.
- Audit Support
- Execute the yearly audit plan, conducting both internal and on-site audits
- Conduct routine internal audits, as required, to ensure consistency and compliance with Care Access SOPs, study protocols, ICH-GCP Guidelines, and other applicable regulatory requirements.
- Other Responsibilities
- Perform other duties as assigned. The duties listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
- Work on specific projects as assigned by Quality Assurance Management
The Expertise Required
- Prior experience with the design, implementation, system administration, and ongoing management of an enterprise eQMS solution, including electronic document management, training, quality issues, CAPAs, audit management, and reporting functionality.
- Excellent working knowledge of medical and research terminology
- Excellent working knowledge of federal regulations and good clinical practice (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 evidence 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 associated systems, electronic data capture, MS Word and Excel
- Ability to balance tasks with competing priorities
- Demonstrate effective 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
Certifications/Licenses, Education, and Experience:
- Bachelor's Degree or equivalent research experience
- 4 years of experience in Clinical Research and 3 years in Quality Assurance
How We Work Together
- Location: This role requires 100% of work to be performed in a remote office or clinical research site environment
- Travel: This is a remote or on-site position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.
- Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
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