"Alerted.org

Description

Under the direct

supervision of the Clinical Trials Administrator, The Regulatory Coordinator is

responsible for submitting and managing all regulatory documentation for the

Institute of Urologic Oncology's clinical research portfolio according to

institutional and federal guidelines. Key duties include submitting

applications to the FDA, IRB, ISPRC, DSMB, ancillary departments, and other

applicable review committees (including at start-up, for all amendments, and at

continuing review); maintaining communication with aforementioned regulatory

bodies; developing informed consent forms; and maintaining regulatory files in

paper and electronic form. The incumbent recognizes and performs necessary

tasks to manage projects and prioritizes work to meet necessary deadlines. The

incumbent is responsible for planning and organizing necessary tasks to ensure

adherence to the study protocol and applicable regulations, such as institutional

policy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good

Clinical Practice (GCP). The Clinical Research Coordinator collaborates with

the Principal Investigator (PI), ancillary departments, central research

infrastructure teams, sponsors, institutions, and other entities as needed to

support the administration of all aspects of studies, including, but not

limited to, compliant conduct, financial management, and adequate personnel

support.

The full hourly salary range for this position is $31.51 - $62.64. Please note that the department's target hourly pay is $31.51.

Qualifications

Required:

+ 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.

UCLA Health welcomes all individuals, without regard to race, sex, sexual orientation, gender identity, religion, national origin or disabilities, and we proudly look to each person’s unique achievements and experiences to further set us apart.