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This is a full time career position with UC Davis Health System, Clinical and Translational Center, located in Sacramento.Working Monday to Friday 8:00am to 5:00pm.This classification is not represented by a union.
A key function of the Clinical Trials Regulatory Analyst is to support the Clinical Trial Office (CTO) clinical trial portfolio and in particular, the investigator-initiated multicenter clinical trial (INdividualized ITI based on fviii(ATE) protection by vwf, 'INITIATE') in Hemophilia. This position will provide regulatory, analytical and administrative support to clinical trials under the CTO management and specifically to the INITIATE Trial.
Job ID 047455
UC Davis is an equal opportunity/affirmative action employer committed to excellence through diversity.
• Working knowledge of clinical research management. Certification by RAC, SoCRA, or ACRP is required.
• Minimum five years 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.
• Possess working knowledge of federal & state regulations, GCP guidelines, HIPAA, institutional policies, and SOPs for conduct of human subjects' research in an academic environment.
• Excellent communication and interpersonal skills, both verbal and written, to maintain effective relationships with staff, colleagues, and external customers.
• 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.
• Knowledge and experience working with key administrative software and computer systems including Windows or Mac OS, Microsoft Office Suite, web browser applications, email applications, RedCap, and Access databases.
• A Bachelor's public health or science related field; a master's degree in Public Health or Health Administration is desirable.
• Must be able to work variable schedule to meet the needs of the department.
• Employee must be able to work off site.
• THIS POSITION MAY BE SUBJECT TO A CRIMINAL BACKGROUND INVESTIGATION, DRUG SCREEN, LIVE SCAN FINGERPRINTING, MEDICAL EVALUATION CLEARANCE, AND FUNCTIONAL CAPACITY ASSESSMENT.