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- Create and maintain a comprehensive training plan
- Maintain an understanding of and assist in development, review and revision of applicable policies and procedures.
- Maintain document control system for policies, procedures and forms.
- In conjunction with operations management, provide oversight of clinical policies and procedures ensuring that the care provided to study participants complies with current medical standards.30% - Direct a team of managers to lead the internal audit process and report audit findings to leadership
- Perform FDA preparedness audits and document finding and corrective actions. Host FDA and other regulatory agency inspections. Assist management with post inspection follow up activities.
- Participate in assessment and resolution of quality issues including complaints related to study activities and corrective action plans. Maintain a system for documentation of these activities.20% - Participate in assessment and resolution of quality issues including complaints related to study activities and corrective action plans. Maintain a system for documentation of these activities.
Work closely with Research Integration and Operations teammates to share information, leverage experience and create consistent practices in addition to supporting local activities.
10% - Identify, coordinate and implement systems that assure GCP compliance and continuous improvements
5% - Ensure Quality Assurance disciplines are synchronized in approach, providing continuity between the department resulting in consistent decision making and superior service.
Support the continual advancement of business processes in Quality Assurance assuring compliance and efficiency.
5% - Mentor and develop teammates.
Know, understand and follow teammate guidelines, employment policies, and department or company procedures. Foster a positive work environment.
5% - Other duties as assigned
REQUIREMENTS: - Bachelor's Degree is required
- 10 or more years of Clinical Research experience to include a wide variety of therapeutic research or equivalent experience
- 5 or more years of managing Quality programs or equivalent experience
- Ability to travel up to 30% depending on business needs Experience with in developing standard operating procedures. Ability to manage multiple projects, meet deadlines, and adjust priorities appropriately in an evolving work environment with shifting time frames; self-starter with high degree of initiative, urgency, and follow through.
- Experience in managing confidential information and/or issues using discretion and judgment.
- Experience in pharmaceutical clinical operations and controls; change management processes, regulatory affairs, or validation preferred.
- Experience with computer system validations and regulatory affairs is strongly preferred
- Extensive knowledge and understanding of ICH GCP and Federal Regulations is required
- Experience facilitating FDA, Health Authority and/or customer audits
- 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
- Certified Clinical Research Coordinator (SOCRA or ACRP) is preferredDaVita 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 assists 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:
- Using technology to allow clinical trial enrollment remotely to increase options for patients and enhance patient experienceWhat 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 rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at
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
$100, $147,000.00 / year
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 rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at
Director, Quality Assurance - Minneapolis, United States - DaVita
Description
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 Director - Quality Assurance (Clinical Research) position with DaVita Clinical Research (DCR)
DaVita Clinical Research (DCR) is seeking a Director of Quality Management who will be responsible for creating and managing a comprehensive quality and training program for our nationwide clinical research organization. This position leads a team that drives quality in clinical research operations. The quality program includes policies and procedures, teammate and investigator training, regulatory management and auditing for clinical research sites in the DaVita network. This position oversees, monitors and reports on operational quality and compliance in accordance with Federal and State Regulations.
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:
30% - Works autonomously to create and manage a high functioning quality program across all research sites