What are the responsibilities and job description for the Sr. Regulatory Coordinator position at UCLA Health?
Description
The Regulatory Coordinator will manage the regulatory aspects of complex clinical research studies, ensuring compliance with internal UCLA, FDA, and sponsor requirements. This role involves reviewing clinical research protocols, preparing and submitting necessary regulatory documents, and collaborating with study monitors to ensure timely collection and processing of required paperwork. The position requires attention to detail and adherence to federal, state, and university regulations to support the successful execution of research studies.
Salary: $6,350 - $13,233.33 per month
Qualifications
Required:
The Regulatory Coordinator will manage the regulatory aspects of complex clinical research studies, ensuring compliance with internal UCLA, FDA, and sponsor requirements. This role involves reviewing clinical research protocols, preparing and submitting necessary regulatory documents, and collaborating with study monitors to ensure timely collection and processing of required paperwork. The position requires attention to detail and adherence to federal, state, and university regulations to support the successful execution of research studies.
Salary: $6,350 - $13,233.33 per month
Qualifications
Required:
- Minimum of 3 years of experience of clinical research coordination
- 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 ecommendations, 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.
- 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.
- Bachelors degree
Salary : $6,350 - $13,233
