825 S 8th StSte 400, Minneapolis, Minnesota, 55404-1208, United States of America
We are looking for a highly motivated, positive, and innovative Senior Quality Assurance Administrator to ensure the quality and compliance of clinical research activities. DCR prides itself on a culture of growth, transparency, and feedback. We want a teammate who is compassionate, purposeful, and motivated by meaningful work.
The primary purpose of this position is to support the implementation and maintenance of a robust quality assurance system that meets all regulatory and internal standards. This involves conducting internal audits, developing, and delivering training programs, assisting in the development and revision of policies and procedures, and collaborating with cross-functional teams to identify and resolve quality issues. The ultimate goal is to protect the safety and well-being of study participants while ensuring the integrity and compliance of all clinical research activities.
This position can be based within a home office/remote or hybrid if located within Minneapolis.

MINIMUM QUALIFICATIONS:

• High School Diploma or equivalent is required
• BS/BA is strongly preferred
• A minimum of 4 years of related experience to include clinical quality management/healthcare industry and/or clinical research experience within a research capacity and/or healthcare environment is strongly preferred.
• Extensive knowledge of ICH GCP and federal regulations is required
• Experience in electronic regulatory systems is strongly preferred
• Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities improve operations and effective implementation to reduce errors
• Demonstrated ability to create a comprehensive audit program and carry out audits of investigator sites and clinical research vendors for Phase I-IV studies. Requires an in-depth knowledge of auditing principles, techniques, and communication skills to convey findings and report deficiencies clearly and efficiently to auditees as well as the Company’s management
• Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and effective implementation to reduce errors
• Ability to travel up to50% of the time depending on business needs - overnight travel. We anticipate the travel to be 30-50% the first year, visiting sites etc. It will fluctuate depending on the needs of the business that first year.
• 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.
• Excellent verbal and written communication skills
• Experience in managing confidential information and/or issues using discretion and judgment.
• Commitment to and role model of DaVita’s values with ability to demonstrate those positively and proactively to patients, teammates, management, physicians, and/or vendors (Village Service Partners) in everyday performance and interactions.
  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 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.

We are 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

10% - GENERAL RESPONSIBILITIES:

• Able to work autonomously within a high-functioning quality assurance program.
• Participates in special assignments on various project teams and work streams as determined by management.
• Knows, understands, and follows teammate guidelines, employment policies, and department and company procedures.
• Fosters a positive work environment and champions DaVita’s Mission and Core Values.