Description
The Department of Medicine, Division of Digestive Diseases, is seeking to hire an experienced Research Compliance Analyst to oversee the regulatory coordination of complex clinical research studies within its assigned units, departments, or divisions. This role involves conducting thorough reviews of clinical research protocols and using that information to prepare, manage, and submit all necessary study and regulatory documents, including applications and forms required by UCLA, the FDA, study sponsors, and other regulatory bodies. The analyst will collaborate with study monitors to ensure the timely processing, review, and collection of regulatory documents, maintaining full compliance with federal, state, and university laws, regulations, and policies. Annual range: $76,200-$158,800
Qualifications
Required:
- Minimum of 3+ years of experience of clinical research coordination
- 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.
- 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.
- Demonstrated 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.
Preferred:
|