The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
The Regulatory Coordinator will work with the Network Clinical Research Team and UCLA study teams that support the JCCC Clinical Research Unit, the UCLA/Translational Research in Oncology-US, Inc. (TRIO-US), and the Community Oncology Research Networks, in the set-up and conduct of network clinical trials. Assist with the coordination of study regulatory set-up for all Network clinical trials. Work with the UCLA Study Teams and Pharmaceutical sponsors and CROs in preparing, compiling and shipping required regulatory documents. Respond to and resolve sponsor queries-written and verbal, and assist with the review and preparation of Network site study consent forms. Prepare and submit Network site study-specific regulatory documents to central IRB for review. Track approvals and follow-up with continuing review reports and amendment submissions as needed. Assist with tracking, maintaining and keeping required regulatory documents current. Conduct annual regulatory reviews and updates. Maintain Network database and prepare and maintain Network Study Regulatory Binders. Prepare for and assist with Sponsor and internal monitoring visits and reviews for Network Regulatory documents. Assist in preparing for internal and external audits. Maintain site lists, phone lists, required regulatory documents. Prepare and assist with Network mailings. Disseminate necessary study information to Network sites. Work with the Network Regulatory Affairs Team, which supports the UCLA/Community Oncology Research and Translational Research In Oncology-US, Inc. Network sites. Collaborate with Network Staff and the Clinical Research Unit in the conduct of clinical trials Network practices are located throughout United States and assist with International sites, as required.
· be flexible in handling work delegated by more than one individual
· concentrate and focus in a work environment that contains distracting stimuli and competing deadlines
· handle confidential material with judgement and discretion
· multi-task and prioritize effectively
· organize multiple projects for efficiency and cost-effectiveness
· work efficiently and complete tasks with a high degree of accuracy
· work flexible hours to accommodate research deadlines
Analytical skills sufficient to work and solve problems with minimal supervision.
Strong interpersonal communication skills to effectively and diplomatically interact with others.
Strong written communication skills, ability to compose correspondence and maintain large file system.
Sufficient computer and computer networking knowledge to problem solve common hardware and software problems for novice users via the telephone.
Typing and computer skill/ability including word-processing, use of spreadsheets, e-mail and data entry into clinical trials and Network database (MAC, PC, WORD, WORD PERFECT, EXCEL, MIRCOSOFT).
Clinical research experience in an administrative position in the subspecialty of Hematology- Oncology. 1-year experience with regulatory document submission to central IRB for review, followed by document tracking and follow-up, with continuing review report and amendment submissions as needed.
One-year experience in clinical research in the subspecialty of Hematology-Oncology preferred
Knowledge and experience in a Network research setting. Research certification preferred.
Demonstrated experience with multi-study and multi-site clinical research activities.
Demonstrated knowledge and understanding of human research policies, regulations, procedures and standards as according to HIPAA, IRB, FDA, ICH, and GCP guidelines.
Demonstrated knowledge of FDA and Sponsor regulatory requirements.
Knowledgeable of FDA and QA audit processes.
Demonstrated familiarity with the requirements for network and Sponsor study and regulatory documentation.
Required knowledge of Microsoft Word, Excel, PowerPoint, Outlook, Internet Explorer, and FileMaker Pro.
Working knowledge of good clinical practices for clinical research Hematology-Oncology.
Sufficient math ability and knowledge of clinical trials budgeting process to assist with the preparation of clinical trial budgets.
UCLA is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.
Internal Number: 87306336
About UCLA Health
Altria Group is a FORTUNE 200 company that leads the premier tobacco companies in the United States. Headquartered in Richmond, Virginia, Altria Group holds diversified positions across tobacco, alcohol, and cannabis. Our tobacco companies include some of the most enduring names in American business: Philip Morris USA, U.S. Smokeless Tobacco Company, John Middleton. We have 35 percent ownership of JUUL Labs, Inc., the nation’s leading e-vapor company. And we have an 80 percent interest in Helix Innovations, which manufactures and markets on!, an oral tobacco-derived nicotine pouch product. We complement our total tobacco business with our ownership of Ste. Michelle Wine Estates and our significant equity investment in Anheuser-Busch InBev, the world's largest brewer. Altria’s significant stake in Cronos Group, a leading global cannabinoid company, represents an exciting new global growth opportunity.
At Altria, we celebrate the power of diverse teams working together to shape our future. We are inspired to bring our best because our unique strengths are valued. We believe our personal success and progress should be guided by Our Cultural Aspiration, a new articulation of what w...e value and who we aspire to be, collectively. Our Cultural Aspiration respects and complements individual identity, embracing each other’s unique strengths, welcoming newcomers and developing the best, most inclusive and diverse teams. Over the next 10 years, we have the opportunity to make more progress on harm reduction than we have in the past 50 years. Join us as we work together to shape a better future for adult tobacco consumers, our employees, and our shareholders. Each Altria company is an equal opportunity employer.