The Clinical Trials (CT) Compliance position is located at the regional CT Compliance Department. This position performs internal 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, KP Institutional Review Board approvals, regulatory agency guidelines, and KP policies and procedures. This position is also responsible for supporting CT compliance training and education, development of corrective action plans and follow-up. This position provides CT compliance and risk management consultation to investigators in clinical trial sites across the region. Develops and implements new compliance/risk systems. Works in conjunction with the KPNC clinical trial investigators and CT Operations regarding ongoing cost-effective CT, compliance and risk evaluations. This position is also responsible for protecting the health, safety, and welfare of research participants.
Major Responsibilities / Essential Functions:
* Conducts on site clinical trial compliance monitoring and provides prompt feedback to research staff and management. Implements 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 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 training programs and supports training delivery at local research sites.
* Tracks and implements updates/changes to research compliance and risk management policies and procedures. Acts as the "train the trainer" designee for assigned clinical research areas and supports deployment of a variety of training and education initiatives within the KPNC clinical trial research structure. Promotes feedback loop between compliance and training personnel/leadership within the clinical trials research structure to address deficiencies and prompt refresher training. Provides ongoing communication and feedback to the Principal Investigator and appropriate manager at the research site regarding status of training programs or audits, and compliance related performance of department personnel.
* 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 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, including the acquisition, organization and dissemination of information, data analysis and documentation. Provides support services to appropriate CT staff in implementing risk management principles into training and credentialing processes.
* In conjunction with the CT compliance and operations management, ensures that audit processes are in alignment with research risk processes. Implements 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). 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 director and appropriate reporting department/staff to produce ongoing reports related to compliance and risk management. May assist regional CT management in evaluating and formulating risk procedures, department goals and objectives. Assumes responsibility for related projects as assigned.
* Establishes appropriate working relationships with peers. Requires extensive travel in the KPNC Service Areas. Must have own reliable Transportation for travel. Performs job functions according to the factors listed below under Job Criteria.
* Bachelors Degree or Associate degree with four (4) years experience in a directly related field.
* Minimum three (3) years clinical trials research experience
* Minimum two (2) years experience related to regulatory compliance in healthcare or related field.
* Demonstrated knowledge of and adherence to federal, state, and other regulatory standards, requirements, and guidelines related to clinical trials research.
* Demonstrated excellent written and oral communication and presentation skills.
* Demonstrated experience in conducting effective training sessions with staff.
* 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 analytical and critical thinking skills.
* Strong computer skills in Microsoft systems, including Word, Excel and Power Point.
* Proficient in conflict resolution, group interaction and team building.
* Effective communication, negotiation and leadership skills.
* Outstanding facilitation skills.
* Proficiency in developing and administering needs assessments, analyzing problems and developing action plans.
* Must be able to work in a labor/management partnership environment.
Preferred Work Experience and Qualifications:
* Clinical Trial monitoring or auditing experience strongly preferred.
* Experience in coordinating clinical trials preferred.
* Strong knowledge of database systems.
* Certified by Association of Clinical Research Professionals (ACRP) and /or Society of Clinical Research Associates (SoCRA) or Registered Quality Assurance Professionals in GCP (RQAP-GCP).
* 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.
* Working knowledge or experience with audit techniques, concepts and standards. If candidate is submitted with Associates degree, HM would prefer an associates in Nursing. Bachelor's degree is preferred.
Top Daily Responsibilities Audit clinical trials, prepare reports, conduct site visits, develop training and education, coordinate meetings
Top Skills Candidates Should Have Clinical research experience, monitoring experience preferred. Excellent report writing and Excel skills
Additional Preferred Skills Professional demeanor. Able to answer questions under pressure.