ResponsibilitiesThe 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.
At UCLA Health, you can help heal humankind, one patient at a time by improving health, alleviating suffering and delivering acts of kindness. As you do, you’ll achieve great things in your life and your career. We’re a world-class health organization with four hospitals consistently recognized among the nation’s very best as well as an internationally-renowned medical school, primary and specialty care clinics and much more. Within our dynamic, innovative and growing organization, you’ll find exceptional opportunities to make the most of your abilities in a supportive, empowering and inclusive environment. If you embrace our values of Integrity, Compassion, Respect, Teamwork, Excellence and Discovery we invite you to see all you can accomplish at UCLA Health.