Clinical Trials Internal Auditor - 113040
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#113040 Clinical Trials Internal AuditorExtended Review Date: Tue 1/25/2022
For the safety and well-being of the entire university community, the University of California requires, with few exceptions, that all students, faculty and staff be vaccinated against the COVID-19 virus and influenza before they will be allowed on campus or in a facility or office. For more information visit: Flu Vaccine Mandate / COVID Vaccine Policy
This position will remain open until a successful candidate has been identified.
UCSD Layoff from Career Appointment: Apply by 12/03/2021 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 12/14/2021. Eligible Special Selection clients should contact their Disability Counselor for assistance.
The Moores Cancer Center is one of just 51 in the United States to hold a National Cancer Institute (NCI) designation as a Comprehensive Cancer Center. As such, it ranks among the top centers in the nation conducting basic and clinical cancer research, providing advanced patient care and serving the community through outreach and education programs. The Cancer Center's mission is to translate promising scientific discoveries into new and better options for the care of patients with cancer. The Center supports one of the broadest ranges of cancer activities in the nation - from fundamental and translational cancer research in molecular genetics and advanced molecular therapeutics, and from population studies of cancer incidence to community education about cancer prevention and risk reduction.
The Clinical Trials Internal Auditor Serves as a liaisons between the CTO Quality Assurance department, Quality Associate Director and Biostatistics department to ensure consistent communication and facilitate escalation between monitoring and auditing team. Acts as a resource for investigators and their teams (this includes answering questions, advising on corrective/preventative action, root cause analysis, clarifying requirements, resolving problems, etc.). Support the facilitation and execution of Data Safety Monitoring Committee (DSMC) Meetings. Responsible for exercising discretion, analytical skill, personal accountability and responsibility in a wide range of areas including academic, administrative, managerial functions. Work involves creating, integrating, applying and sharing knowledge directly related to IIT trials. The DSMC Auditors perform the real-time monitoring or semi-annual auditing of the IIT at the institutional level as approved by UCSD Moores Cancer Center Data and Safety Monitoring Plan (DSMP).
The trials are either monitored/audited based upon the risk assessment. Phase I/Pilot/Gene therapy/Vaccine therapy trials are typically monitored monthly, dependent upon accrual, and beginning within the first month of the initiation of enrollment. The DSMC auditor conducts real-time monthly monitoring of all treated study participants through the Dose Limiting Toxicity (DLT) period for Phase I/Pilot/Gene Therapy/Vaccine Therapy Institutional trials and conducts three, six, and annual auditing of at least twenty percent of all enrolled study participants for Phase II and III Institutional and NCI trials. The regulatory files for all trials are audited on a biennial basis for regulatory compliance. The DSMC auditor also reviews planned interim analysis on IIT institutional trials, and assists with the development of Corrective and Preventative Action Plans (CAPAs), and evaluates any safety of study design concerns raised by the PI, DSMC, the Protocol Review and Monitoring Committee (PRMC), or the IRB. The DSMC Monitoring Office also provides audit preparation for Industry Sponsored Quality Assurance Audits, Audits, and FDA Inspections.
Seven (7) years of related experience, education/training, OR a Bachelor’s degree in related area plus three (3) years of related experience/training.
Experience working with Investigational New Drug procedures, study protocols, the informed consent process, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and applicable regulatory requirements.
Thorough knowledge of FDA regulations, Institutional Biosafety Committee policy and NIH guidelines as they relate to Investigator Initiated Trials (IIT).
Experience with regulatory issues in clinical research. Experience with FDA, NCI, and ICH regulations and guidelines for clinical studies and medical devices, including GCP's and GMP's. Knowledge of compliance issues and experience in adherence counseling techniques. Thorough knowledge of Federal and University polices on clinical trials and protection of human subjects.
Experience in maintaining quality control in clinical research activities. Working knowledge of auditing processes in the drug development and approval process. Working knowledge and understanding of complex audits that require interpreting regulations, guidelines, and compliance issues. Experience in developing, implementing, evaluating, and documenting audit procedures.
Proficiency with computers, including the ability to operate personal computer software with sophisticated retrieval, storage, and merging capabilities. Experience working with large databases and patient data.
Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents. Thorough knowledge of current HIPAA regulations as they apply to research.
Proven knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology. Knowledge of medical, pharmaceutical and scientific terminology and concepts, and/or of biological science, and cancer diagnosis and treatment methods sufficient to understand the contents of medical research protocols and research processes. Extensive experience with clinical trials methodology.
Strong proficiency in public speaking, and writing. Effective, efficient and tactful oral and written communication skills.
Thorough knowledge of Good Clinical Practices and other federal guidelines for protection of human subjects. Thorough knowledge of FDA policies regulating clinical trials.
Proven understanding of auditing processes in the drug development and approval process. In-depth knowledge and understanding of complex audits that require interpreting regulations, guidelines, and compliance issues. Experience in developing, implementing, evaluating, and documenting audit procedures.
Working knowledge of planning, implementing and evaluating clinical research studies and writing and submitting clinical trials protocols.
- Five (5+) or more years of experience as a Clinical Research Associate (CRCA monitor), Clinical Trial Auditor, or Clinical Regulatory Monitor.
- CCRC certification.
- Proven advanced knowledge of oncology.
- Experience working with institutional IIT-Multi-center auditing.
- Employment is subject to a criminal background check and pre-employment physical.
- Must be able to maintain strict confidentiality.
- Must be willing to travel up to 10% of the time as needed.
- Must be available to work occasional evenings and weekends as needed.
Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).
UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team!
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