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 and/or clinical research experience within a research capacity and/or environment.

• 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.

Applications are accepted on an ongoing basis.

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.