The Clinical Trials (CT) Compliance & Quality Coordinator position is located at the regional CT Compliance Department in Oakland. This position performs internal quality assurance and compliance auditing of work conducted within the KPNC CT research program to ensure accuracy, timeliness, quality of work, and compliance with all applicable federal, state, and local regulations, accreditation bodies, KP IRB approvals, regulatory agency guidelines, and KP policies and procedures. This position is also responsible for supporting CT compliance training and education, and validation of corrective action plans. This position provides CT compliance, quality, and risk management consultation to investigators in clinical trial sites across the region. Develops and implements new clinical trial quality/compliance/risk systems. Works in conjunction with the KPNC 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. This job requires extensive travel in the KPNC Service area. Must have own reliable transportation for travel.
Essential Functions:
- Conducts on site clinical trial quality assurance/ compliance monitoring & provides prompt feedback to research staff & management
- Makes recommendations for corrective action plans to the CT research site & satellite sites when a confirmed quality/compliance/risk issue is identified
- Implements updates/revisions to quality & compliance standards/monitoring systems to ensure and meet regulatory objectives
- Works closely w/ the clinical trials program structure related to training, & operations functions; supports delivery of training & education to promote a continuous learning environment
- Measures effectiveness of training sessions & materials
- Provides input to the development & updating of Human Research Protections & CT training programs & supports training delivery at local research sites
- Implements updates/changes to research compliance & risk management policies & procedures
- Acts as the 'train the trainer' designee for assigned clinical research areas & supports deployment of a variety of training & education initiatives within the KPNC clinical trial research structure
- Promotes feedback loop between quality/compliance & training personnel/leadership within the clinical trials research structure to address deficiencies & prompt refresher training
- Provides ongoing communication & feedback to the Principal Investigator & appropriate manager at the research site regarding status of training programs or audits, & compliance related performance of department personnel
- Maintains current knowledge base to assist in the development & 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 & prepares 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
- Provides support services to appropriate CT staff in implementing risk management principles into training & credentialing processes
- In conjunction w/ the CT compliance & operations management, ensures that audit processes are in alignment w/ research risk processes
- Conducts audits to assess adherence w/ policies & legal/regulatory requirements
- Ensures timely presentation of audit findings & recommendations to management via reports
- Appropriately conducts & documents all audit processes & findings
Qualifications:
Basic Qualifications:
- Significant experience (usually 5+ years) in quality assurance/improvement &/or compliance in a health care setting required
- Previous clinical research & management experience required
- Experience related to regulatory compliance in healthcare or related field preferred
- Clinical nursing experience in the last 7 years strongly preferred
- Bachelor's degree in Nursing or Health Care related field or equivalent experience in clinical research required
- Current California RN license (preferred) or other clinical licensure required
- Valid CA driver's license
- Current BLS certification required
- Certified Professional in Healthcare Quality (CPHQ) or Registered Quality Assurance Professionals in GCP (RQAP-GCP) preferred
- Willingness to obtain other certifications, if required
- Knowledge of & adherence to federal, state, & other regulatory standards, requirements, & guidelines related to clinical trials research
- Working knowledge of ongoing monitoring techniques (including criteria development & trending); medical care delivery in hospital & outpatient settings; quality management principles, tools, & risk management techniques are required
- Knowledge or experience w/ audit techniques, concepts, & standards
- Effective communication, negotiation, & leadership skills
- Excellent written & oral communication & presentation skills
- Experience in conducting effective training sessions w/ staff
- Strong analytical & critical thinking skills required
- Strong knowledge of database systems preferred
- Ability to work in a team-based, collaborative environment
- Ability to manage projects & work independently to develop creative solutions to ongoing complex issues/challenges
- Strong computer skills in Microsoft systems, including Word, Excel, & Power Point
- Proficient in conflict resolution, group interaction, & team building
- Proficiency in developing & administering needs assessments, analyzing problems & developing action plans required
- Outstanding facilitation skills
- Must be able to work in a labor/management partnership environment
External hires must pass a background check/drug screen.
We are proud to be an equal opportunity/affirmative action employer.