Quality Assurance Manager at Care Access

Remote, US

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What We Do
Care Access is delivering the future of medicine today. By uniting healthcare staff with centralized research operations and technology, we have built one of the nation’s largest clinical research companies. Care Access has grown rapidly through 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 values are rooted in sincerity, passion, and a collective drive to build a dramatically better clinical trials community. Our culture is one of open dialogue and respectful communication: every member of the Care Access team has an equal voice. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere.

Position Summary
Care Access is looking for a Quality Assurance Manager. The Quality Assurance Manager will oversee the activity of the Quality Assurance Department and staff, developing, implementing, and maintaining a system of quality and reliability for both IRO and DRO organizations, with and in support of the Director of Quality Assurance, to  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:
-Provide coaching and supervision to QA team which includes relaying feedback, training and onboarding new staff, and ensuring team members are performing to standard of their role
-Provide support to the Quality Department through the administration and maintenance of quality systems, programs, and processes
-Ensure that all processes contributing to the performance of a clinical trial are conducted properly
-Manage and maintain databases for the quality systems
-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 leaders of 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
-Lead, 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 and Travel Requirements:
This is a remote position with travel and up to 30-40% travel requirements. Planned travel is required for this role.

What You Bring: 
Knowledge, Skills, and 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 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 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  

Certifications/Licenses, Education, and Experience: 
-Bachelor’s Degree or equivalent research experience  
-A minimum of 3 yrs of experience in quality assurance and management 
-A minimum of 5 yrs 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. We do not discriminate based on race, sex, religion, color, national origin, gender identity, age, marital status, veteran status, or disability status.
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 a unique technology-enabled service model. 
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 unable to sponsor work visas at this time.

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