Research Compliance Regulatory Auditor / Quality Assurance Reviewer
Primary Location Pasadena, California
Job Number 1196113 Date posted 11/29/2023
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Description:
Conducts on site (including multi-site) clinical trial quality assurance/ compliance monitoring and provides prompt feedback to research staff and management.
Assists the CT Quality & Compliance Manager in the development of recommendations to the KPSC CT Quality Committee (CTQC) for corrective action plans to the CT research site and satellite sites when a confirmed quality/compliance/risk issue is identified.
Collaborates with audit team in the development and implementation of updates/ revisions to quality and compliance standards/monitoring systems to ensure regulatory objectives are met.
Works closely with the clinical trials program structure related to training, and operations functions; supports delivery of CT compliance training and education to promote a continuous learning environment.
Measures accuracy, comprehension, and effectiveness of training sessions and materials.
Provides input to the development and updating of Human Research Protections (as requested) and CT compliance training programs and supports training delivery at local research sites.
Seeks current information and maintains current knowledge base to assist in the development and implementation of the compliance risk management processes.
Develops criteria by which risk management needs within the CT program may be assessed.
Analyzes risk management data and makes recommendations for the incorporation of risk management principles at each CT site.
Promotes effective interaction among the CT research sites in the establishment of risk identification systems, including the acquisition, organization and dissemination of information, data analysis and documentation.
In conjunction with the CT compliance and operations management, ensures that audit processes are in alignment with research risk processes.
Assist in the implementation of audit controls and conducts audits to assess adherence with policies, procedures, and legal/regulatory requirements.
Ensures accurate and timely presentation of audit findings and recommendations to management via verbal and written reports.
Appropriately conducts and documents all audit processes and findings.
Assists in the collection and trending of data from site reports (e.g. external monitor reports, protocol violation reports, etc) and quality assurance audits.
Validates continued maintenance of corrective action plans and conducts compliance investigations as appropriate.
Compiles risk management information for dissemination to CT sites in a timely manner.
Provides input to the development and dissemination of best practices across the CT research program.
Works in conjunction with CT Quality and Compliance Manager and appropriate reporting department/staff to produce ongoing reports related to compliance, risk management, and quality.
May assist regional CT management in evaluating and formulating quality/risk procedures, department goals and objectives.
Assumes responsibility for other projects as assigned.
Establishes appropriate working relationships with peers.
Requires extensive travel in the KPSC region.
Must have own reliable transportation for travel.
Performs job functions according to the factors listed below under Job Criteria.
Minimum four (4) years of experience in quality assurance/improvement and/or compliance in a health care setting required.
Bachelor's degree in public health, health care administration or other related field OR four (4) years of experience in a directly related field.
High School Diploma or General Education Development (GED) required.
N/A.
Working knowledge or experience with audit techniques, concepts and standards.
Willingness to obtain other certifications, if required.
Demonstrated knowledge of and adherence to federal, state, and other regulatory standards, requirements, and guidelines related to clinical trials research.
Strong working knowledge of ongoing monitoring techniques (including criteria development and trending); medical care delivery in hospital and outpatient settings; quality management principles, tools, and risk management techniques are required.
Effective communication and leadership skills.
Demonstrated excellent written and oral communication and presentation skills.
Strong analytical and critical thinking skills required.
Demonstrated ability to work in a team-based, collaborative environment.
Demonstrated ability to manage projects and work independently to develop creative solutions to ongoing complex issues/challenges.
Strong computer skills in Microsoft systems, including Word, Excel and Power Point and other web-based systems.
Must be able to work in a Labor/Management Partnership environment.
Experience related to regulatory compliance in healthcare or related field preferred.
Strong knowledge of database systems preferred.
Current CRA certification or CCRP; CIP, preferred.
BA/BSN in Nursing.
The Clinical Trials (CT) Quality Assurance Reviewer position(s) is located at the Kaiser Permanente Southern California Department of Research & Evaluation (R & E) Clinical Trials Division. This position performs internal quality assurance and compliance auditing of clinical trials work conducted within the Southern California (SC) region to ensure accuracy, timeliness, quality of work, and compliance with all applicable federal, state, and local regulations, KPSC Institutional Review Board approvals, regulatory agency guidelines, and KP policies and procedures. This position is also responsible for consultation regarding CT compliance training and education and of CAPA follow-up and validation. This position provides CT compliance, quality, and risk management consultation to investigators in clinical trial sites across the region. Position assists in the development of and implementation of new clinical trial quality/compliance/risk systems. Position works in conjunction with the KPSC clinical trial investigators and CT Operations regarding ongoing cost-effective CT quality, compliance and risk activities. This position is also responsible for protecting the health, safety, and welfare of research participants.
Essential Responsibilities:
Basic Qualifications:
Experience
Education
License, Certification, Registration
Additional Requirements:
Preferred Qualifications:
Primary Location: California,Pasadena,Walnut Center - Regional Offices
Scheduled Weekly Hours: 40
Shift: Day
Workdays: Mon, Tue, Wed, Thu, Fri
Working Hours Start: 09:00 AM
Working Hours End: 06:00 PM
Job Schedule: Full-time
Job Type: Standard
Employee Status: Regular
Employee Group/Union Affiliation: NUE-SCAL-01|NUE|Non Union Employee
Job Level: Individual Contributor
Department: Internal Audit and Compliance
Pay Range: $104300 - $134970 / year
The ranges posted above reflect the location in the job posting. The salary range may vary if you reside in a different location or state than the location posted.
Travel: Yes, 10 % of the Time
At Kaiser Permanente, equity, inclusion and diversity are inextricably linked to our mission, and we aim to make it a part of everything we do. We know that having a diverse and inclusive workforce makes Kaiser Permanente a better place to receive health care, a more supportive partner in our communities we serve, and a more fulfilling place to work. Working at Kaiser Permanente means that you agree to and abide by our commitment to equity and our expectation that we all work together to create an inclusive work environment focused on a sense of belonging and wellbeing.
Kaiser Permanente is an equal opportunity employer committed to a diverse and inclusive workforce. Applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), age, sexual orientation, national origin, marital status, parental status, ancestry, disability, gender identity, veteran status, genetic information, other distinguishing characteristics of diversity and inclusion, or any other protected status. Submit Interest
Kaiser Permanente is an equal opportunity employer committed to a diverse and inclusive workforce. Applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), age, sexual orientation, national origin, marital status, parental status, ancestry, disability, gender identity, veteran status, genetic information, other distinguishing characteristics of diversity and inclusion, or any other protected status. Submit Interest
