Responsible for regulatory coordination of clinical research studies within assigned units, departments or divisions. Performs detailed review of clinical research protocols and utilizes that information to prepare, manage and submit all required study/regulatory documents and all required applications and forms related to internal UCLA requirements, FDA requirements, sponsor requirements, etc. Works with study monitors to process, review and collect the appropriate regulatory documents in a timely manner and in compliance with federal, state, and university mandated laws, regulations and policies.
QualificationsRequired:
• Minimum of 1+ years of experience as a clinical researcher
• Interpersonal skills to effectively communicate information in a timely, professional manner and establish and maintain cooperative and effective working relationships with students, staff, faculty, external collaborators and administration and to work as a member of a team.
• Ability to set priorities and complete ongoing tasks with competing deadlines, with frequent interruptions, to meet the programmatic and department needs, while complying with applicable University policies and federal and state regulations.
• Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions.
• Close attention to detail to ensure accuracy in a fast-paced, fluctuating workload environment.
• Organization skills to create and maintain administrative and regulatory files effectively as well as independently balance the various tasks to ensure deadlines are met.
• Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, to perform daily tasks efficiently and accurately.
• A learning and professional growth mentality so that new software tools, systems, and processes can be adopted quickly and efficiently.
• Working knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws.
• Knowledge of and experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc.
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.
