This position serves as a Regulatory Analyst for the Clinical Trials Office (CTO) within the Clinical and Translational Science Center (CTSC) at the UC Davis School of Medicine. A key function of this position is to support the CTO clinical trial portfolio and in particular, the investigator-initiated multicenter clinical trials. This position will provide regulatory support to clinical trials under the CTO management. The duties also include programmatic support, such as data analysis, project management and process improvement..
Regulatory Analyst Qualifications
Bachelor's in Public Health or similar field is required; a master's degree in Public Health or Health Administration is desirable.
Extensive professional regulatory compliance experience in a health care or academic setting.
Demonstrated experience in quality assurance, data analysis and clinical trials research auditing processes.
Advanced background and knowledge of clinical trial operations, including but not limited to IRB and FDA requirements.
Advanced knowledge of federal & state regulations, GCP guidelines, HIPAA, institutional policies, and SOPs for conduct of human subjects' research in an academic environment.
Working knowledge of clinical research management. Certification by RAC, SoCRA, or ACRP is required.
Excellent communication and interpersonal skills, both verbal and written.
Possess good presentation skills for education and training programs.
Possess good investigative skills with a high degree of accuracy and attention to detail.
Analytical skills to evaluate information, practices, and procedures, formulate logical and objective conclusions, and make recommendations for effective solutions, strategies, and/or approaches.
Knowledge and experience working with key administrative software and computer systems including IRBNet, Windows or Mac OS, Microsoft Office Suite, web browser applications, email applications, RedCap, and Access databases.
Must be able to work flexible work schedule as needed.
THIS POSITION MAY BE SUBJECT TO A CRIMINAL BACKGROUND INVESTIGATION, DRUG SCREEN, LIVE SCAN FINGERPRINTING, MEDICAL EVALUATION CLEARANCE, AND FUNCTIONAL CAPACITY ASSESSMENT
To view full job description and submit an on-line application visit UC Davis Career Opportunities at: