Quality Assurance Specialist
Remote, US
535 Quality Assurance – Quality Assurance /
Full Time - Regular /
Remote
What We Do:
Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.
Who We Are:
We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.
Position Overview:
Care Access is seeking a dedicated, experienced, and innovation-driven Quality Assurance Specialist to oversee the Quality Department. 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. Working in support of the 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.
What You'll Be Working On (Duties include but not limited to):
- Provide support to the Quality Department through the administration and maintenance of quality systems, programs and processes
- Ensure high integrity of data and patient safety at the research site through quality assurance review
- Interpret and implement quality assurance standards and procedures
- Track quality assurance audits and other quality assurance activities
- Review study specific regulatory binders and documents to ensure all documents are appropriately completed, submitted and maintained per GCP standards
- Work with research staff and PI to ensure identified issues are addressed
- Review and maintain quality assurance SOPs and procedures
- Develop and track corrective action plans with recommendation and monitor follow up preventative actions as necessary
- Coordinate and support on-site audits conducted by external providers and regulatory agencies
- Prepare reports to communicate outcomes of quality activities
- Execute yearly audit plan
- Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive
Physical & Travel Requirements:
- This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.
What You Bring (Knowledge, Skills, & Abilities):
- 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
- Experience with supporting multiple sites and identifying gaps
Certifications/Licenses, Education, & Experience:
- 2 years of experience in Quality Assurance
- 4 years of experience in Clinical Research
Benefits (US Full-Time Employees Only)
- PTO/vacation days, sick days, holidays.
- 100% paid medical, dental, and vision Insurance. 75% for dependents.
- HSA plan
- Short-term disability, long-term disability, and life Insurance.
- Culture of growth and equality
- 401k retirement plan
Diversity & Inclusion
We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to 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 value diversity and believe that unique contributions drive our success.
At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the best physicians and caring for patients. Our team of experts is paving the way to take this vision forward through innovation and unique technology enabled.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to 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 currently unable to sponsor work.
