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Description

The Regulatory Coordinator is responsible for regulatory coordination of clinical research studies within assigned units, departments or divisions. You will perform detailed review of clinical research protocols and utilize 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. You will work 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.

Other duties include:

+ Utilizing research compliance concepts and apply organizational policies and procedures to perform detailed review of clinical research protocols and develop and implements activation project plan.

+ Reviewing protocol amendments or changes in order to determine if budget and/or contract amendments must be implemented. Notify Principal Investigator, Central Administration, team leader and study team of protocol changes and revision requirements. Act as liaison between all other required hospital and clinic departments in order to reassess protocol requirement changes and prices.

+ Managing all document updates and uploads in the Clinical Research Management System (CRMS) including updated consents, and that research staff are aware of the need to re-consent patients if the informed consent has been amended.

+ Overseeing and managing study closeout visits, and ensure proper submission and maintenance of all required regulatory documentation for study closure, in accordance with applicable laws and institutional policies.

Salary Range: $30.56 - $60.82/Hourly

Qualifications

All Required:

+ Bachelor's degree in related area and/or equivalent combination of education and experience.

+ 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.

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