Senior Quality Assurance Administrator - Clinical Research

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.

Essentials Responsibilities include, but are not limited to:

25% - Audit & Compliance

• Assists in managing internal audit system of clinical research processes and disseminates audit findings to management as directed.

• Performs internal process audits,schedules audits, and tracks trends and issues.

• Conducts internal on-site and remote site audits.

• Assists in post-inspection follow up activities.

• Identifies ways to improve audit and assessment processes and implements the identified improvements.

25% - Quality Assurance & Issue Resolution:

• Participates in the assessment and resolution of quality issues and implements and/or maintains a system for the documentation of these activities.

• Assists in the collection and reporting of quality metrics.

• Contributes to quality by undertaking a variety of roles or assignments to further develop internal processes and teammates.

20% - Training & Development:

• Works with management to develop and maintain the training program for sites and participating DaVita dialysis centers.

• In conjunction with management, assesses and establishes training for teammates.

• Assists in creating and maintaining a comprehensive training plan for site teammates.

• Mentors and develop teammates.

15% - Policy & Procedure Development & Maintenance:

• Assists in the development, review and revision of policies and procedures.

• Maintains an understanding of and assists in the development, review, and revision of applicable policies and procedures.

• Maintains document control systems for policies, procedures, and forms.

• In conjunction with operations management, provides oversight of clinical policies and procedures ensuring that the care provided to study participants complies with current medical standards, DaVita policies and procedures, federal regulations, etc.

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.

5% - Other duties as assigned.

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

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.

Join us as we pursue our vision "To Build the Greatest Healthcare Community the World has Ever Seen."

Why wait? Explore a career with DaVita today.

Go to http://careers.davita.com to learn more or apply.

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 https://careers.davita.com/benefits

This position will be open for a minimum of three days.

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 https://careers.davita.com/benefits

Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.