825 S 8th stSuite 300,Minneapolis,Minnesota,55404,United States of America At DaVita Clinical Research, we find that our best leaders are those who create an inspiring vision, have a desire to shape the future of medicine, and empower their team to achieve success. They enjoy tackling difficult problems and believe that the best way to solve them is through a collaborative environment that involves team efforts. They take ownership of results and instill accountability in those they lead. They are driven, compassionate, strong communicators, relationship builders, and find real fulfillment in challenging and impactful work. Sound like you? Then you might be a great fit for a Senior Manager - Quality Assurance (Clinical Research) position with DaVita Clinical Research (DCR) We are looking for a highly motivated, positive and innovative Sr. Quality Assurance Manager with 3 or more years of quality management experience and a diverse clinical research background. The position is responsible for managing Clinical Trials quality programs.Additional responsibilities include development and maintenance of the clinical research training program.The individual will collaborate with department management to identify and develop goals to meet and exceed internal and regulatory requirements for clinical research facilities, and will report to the Director of Quality. This position is a remote position and will be based out of a home office.This individual can be located anywhere within the U.S, and does not need to be located within Minneapolis. ESSENTIAL DUTIES & RESPONSIBILITIES: Manages the development, review and revision of policies and procedures Assists in managing internal audit system of clinical research processes; reports audit findings to management Performs FDA preparedness audits; document findings and corrective actions and report to operations management. Participates in assessment and resolution of quality issues including complaints related to study activities and corrective action plans; maintain a system for documentation of these and similar activities Assists in the collection and reporting of quality metrics Performs internal process audits, sets schedule and tracks for trends and issues annually Conducts quality visits Works with management to develop and maintain the training program for Alliance sites and participating DaVita dialysis centers In conjunction with management, assesses and establishes Quality training and any additional training programs for research teammates Contributes to quality by undertaking a variety of roles or assignments to further develop internal processes and people Identifies ways to improve audit and assessment processes Participates in special assignments on various project teams and work streams as determined by Quality management Other duties as assigned REQUIREMENTS: High School Diploma or equivalent is required Bachelor's Degree is strongly preferred 5 or more years of Clinical Research experience to include a wide variety of therapeutic research - studies within oncology and/or nephrology is preferred 3 or more years of Quality Management experience Ability to travel up to 35% travel depending on business needs Experience with computer system validations and regulatory affairs is strongly preferred Strong knowledge and understanding of ICH GCP and Federal Regulations is required Research, analytical and communication skills with ability to interpret legal and technical specifications is required. Excellent verbal, written communication, interpersonal skills and superior organizational/planning skills is required Advanced computer skills (MS Word, MS Excel, MS PowerPoint, Adobe Acrobat) is required Strong collaboration and team building skills DaVita Clinical Research (DCR), a wholly owned subsidiary of DaVita Inc., is the research arm of DaVita.DCR innovates through retrospective outcomes research aimed at improving care and quality of life for people with kidney disease. DCR a sists pharmaceutical and medical device companies in the design, recruitment and completion of clinical trials using its renal research site network.For 30 years we have helped 500+ clients with their development projects. DCR is based in Minneapolis, MN and operates in locations across the US. DaVita Clinical Research is dedicated to improving the lives of our kidney care patients through: Industry sponsored clinical trials in End Stage Kidney Disease and Chronic Kidney Disease Internal prospective and retrospective research that helps inform the clinical care of our dialysis facilities and answer critical questions. See our most recent publications: https://www.davitaclinicalresearch.com/media-library/scientific-library/ Using technology to allow clinical trial enrollment remotely to increase options for patients and enhance patient experience What We'll Provide: More than just pay, our DaVita Rewards package connects teammates to what matters most. Teammates are eligible to begin receiving benefits on the first day of the month following or coinciding with one month of continuous employment. Below are some of our benefit offerings. Flexible weekly work schedule:This will vary and is based on current business needs December Industry wellness break (Week between Christmas and New Year's Day) Comprehensive benefits:Medical, dental, vision, 401(k) match, paid time off, PTO cash out Support for you and your family:Family resources, EAP counseling sessions, access Headspace, backup child and elder care, maternity/paternity leave and more Professional development programs:DaVita offers a variety of programs to help strong performers grow within their career, and also offers on-demand virtual leadership and development courses through DaVita's online training platform StarLearning. Here is what you can expect when you join our Village: * A "community first, company second" culture based on Core Values that really matter. * Clinical outcomes consistently ranked above the national average. * Award-winning education and training across multiple career paths to help you reach your potential. * Performance-based rewards based on stellar individual and team contributions. * A comprehensive benefits package designed to enhance your health, your financial well-being and your future. * Dedication, above all, to caring for patients suffering from chronic kidney failure across the nation. Full vaccination against COVID-19 or weekly COVID-19 testing, in addition to wearing a mask, is required. A medical/religious exemption is required for any unvaccinated teammates planning to visit a clinic or working on any of our federal contracts. At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed Diversity & Belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and an affirmative action employer. As such, individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic. Salary/ Wage Range Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience and may fall outside of the range shown. DaVita offers a competitive total... For full info follow application link. DaVita is an equal opportunity/affirmative action employer. As such, DaVita makes hiring decisions solely on the basis of qualifications and experience, and without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability or protected veteran status.