The Department of Medicine is looking for a motivated candidate toperform the duties of a Regulatory Coordinator. Under the direction of theRegulatory Manager and Clinical Research Director, you will assist with allregulatory functions for assigned studies at the CARE Center in addition toserving as the primary point of contact for the Principal investigators andresearch staff. You will also coordinate submission of initial regulatory andinternal UCLA applications (IRB including reliance, IBC, MSRC, CTRC, ISPRC,OnCore, and others), amendments, investigator brochures, and other requiredrequests for assigned projects. You will respond to all queries andcorrespondences in addition to assuring maintenance of all regulatorydocumentation and certifications. Finally, you will perform QA reviews ofIRB/regulatory documentation, while also maintaining tracking on safetyreporting and adverse events. You will oversee the identification to processimprovement needs and contribute to development and implementation. Salary range: $24.28-$48.04 Hourly

Required: •Minimum years of experience: At least 2 years recent experience in a role with hands-on IRB submission and regulatory responsibilities •Demonstrated expertise in protocol assessment, IRB and regulatory submission •Knowledge of medical terminology. •Experience working with faculty, administrators, and staff in an academic medical center, health care or university environment. •Knowledge of research regulatory requirements (including FDA and other federal and state regulations), GCP/ICH guidelines and special requirements for drug and medical device trials. •Ability to set priorities of assignments to complete work in a timely manner when there are changes in workload and multiple deadlines •Strong attention to detail •Prior experience with the IRB-reliance process and/or working with central IRBs •Strong organizational skills Preferred: •Association of Clinical Research Professionals certification or similar research related certification preferred •Strong working knowledge of the full range of regulatory and start-up activities/requirements related to clinical research (e.g., ISPRC, CIRC/ISRC, CTRC, MRSC, RDRC and other regulatory approvals, etc.) •Familiarity with UCLA pharmacy, path/lab, radiology and other ancillary services and research pricing.