UCLA HEALTH

Public Administration Analyst (53077993)
Location: Los Angeles, California - United States
Posted: 9/22/2019

Public Administration Analyst

Responsibilities

Under the direction of the Clinical Trials Manager of the Department of Radiation Oncology, the Compliance Specialist will serve as departmental regulatory expert, responsible for interacting with all campus compliance committees, including Institutional Review Board, Internal Scientific Peer Review Committee, Medical Radiation Safety Committee and Data Safety Monitoring Board, utilizing various electronic interfaces. Working closely with faculty, residents and clinical trials coordinators, prepare and submit new, continuing review and amendment applications and respond to reviewer's correspondence. Create and amend informed consent forms, and amend research protocols as needed. Write explanatory text regarding changes to studies and their scientific/clinical rationale. Provide analysis and written summaries of clinical events for reporting to review committees. Track expiration dates and respond proactively to these deadlines. Constantly utilize OnCore to track submissions.
Work closely with and in support of the clinical trials network sites, to communicate with and collect required compliance documents, review/edit/approve site's informed consent forms, and assist clinical trials network manager in FDA communications and filings, including IND submissions, amendments and reports.
Create, collect, submit and amend all required regulatory documents including FDA Form 1572s, Financial Disclosure Forms, updated CVs and licenses, training certificates, Delegation of Authority logs, and maintain these records for monitoring purposes. Obtain necessary signatures and dates on these documents. Work with and respond to monitors and auditors on regulatory documents. Train and update faculty, residents and staff in changing regulations personally and in department-wide presentations.

Qualifications

Bachelors degree required
5+ years in oncology preferred

Additional Requirments / Information

Job Capacity:Employee (full-time)
Minimum Education Level:See Job Description
Visa Sponsorship: No
Related Industries:Research

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