Remote, us / research hq – clinical quality assurance / remote
The quality assurance specialist is responsible for providing support to the quality department through closely monitoring quality and compliance of clinical work at both the traditional trial sites and decentralized trials, with and in support of the director of quality assurance, to help ensure that care access maintains a high level of quality while executing clinical trials according to care access sops, gcp and fda/ich guidelines.
This role requires occasional travel up to 25%.
Duties include but are 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 reviewinterpret 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 addressedreview and maintain quality assurance sops and procedures develop and track corrective action plans with the 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 assignedThe duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
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 goalsBring 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
Education:
Bachelor’s degree required
Experience:
A minimum of 2 yrs of experience in quality assurance
A minimum of 4 yrs experience in clinical research
Benefits offered:
Pto/vacation days, sick days, holidays.
100% paid medical, dental, and vision insurance50% for dependents.
Hsa plan
Short-term disability, long-term disability, life insurance.
Continued education allowance
Culture of growth and equality
401k retirement plan
About us at care access, every day we are advancing medical breakthroughsWe’re uniting standard patient care with cutting-edge treatments and researchThe work that we do brings life-changing therapies to those who are in need and paves the way for newer and greater treatments to reach the worldWe’re proud to advance these breakthroughs and to work with the big players while also engaging with the very best physicians and caring for patientsThrough innovation and a unique technology-enabled service model, our team of experts is paving the way to take this vision forward.
We careOur values are rooted in being genuine, finding new ideas, and building something meaningfulInfluenced by our values, we have built a culture valuing communication and dialogue: we care about what everyone has to say and we spend energy on being equal and inclusiveAlong the way, we are caring for each other, accelerating medicine, and seeding a long-term impact for generations to come.
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.
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