Remote Monitoring Coordinator

2 weeks ago

London, Greater London, United Kingdom UC Irvine Health Full time
Regulatory Affairs Coordinator - Hybrid A

Location:
Remote-Campus

Reports To:
Regulatory Program Manager

Working Title:
REGULATORY AFFAIRS COORDINATOR - HYBRID

Bargaining Unit:

RX

Under the supervision of the Regulatory Program Manager (RPM) of the Regulatory Affairs Unit, the Regulatory Affairs Coordinator (RAC) supports the clinical research efforts of the Chao Family Comprehensive Cancer Center by providing comprehensive, regulatory management of cancer-related protocols in accordance with human subject federal regulations, internal standard operating procedures (SOPs), and University policies and procedures.

Responsibilities related to regulatory coordination activities include independently managing and preparing submissions of new studies, modifications, renewals, adverse events, and study closures to the Institutional Review Board (IRB), Food and Drug Administration (FDA) and other ancillary committees including, but not limited to, Disease-Oriented Teams (DOTs), Protocol Review and Monitoring Committee (PRMC), Data and Safety Monitoring Board (DSMB), Institutional Biosafety Committee (IBC), Radiation Safety Committee (RSC), and Epidemiology Infectious Prevention (EIP).

The RAC is responsible for effectively shepherding protocols through the regulatory committee process in a timely manner to ensure activation of trial and for all regulatory aspects of the protocols assigned.

In addition, the RAC serves as the liaison to sponsors, governing agencies and facilitates transmission of verbal and written communication to National Clinical Trials Network (NCTN) groups, pharmaceutical companies, and other research entities as needed.

The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, including attending Disease Oriented Teams (DOTs) meetings, interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.

The incumbent must accurately maintain regulatory information in the clinical trial management system (OnCore) and adhere to institutional policies and external Cancer Center Support Grant guidelines for reporting to the National Cancer Institute (NCI).


Total Compensation:

These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks.

Please utilize the links listed here to learn more about our compensation practices and benefits .
~ Institutional Review Board, Protocol Review Monitoring Committee, Data Safety Monitoring Board, Institutional Biosafety, Radiation Safety Committee, and Epidemiology Infectious Prevention.
~3 to 5 Years of related work coordination work experience with Bachelor of Arts/Bachelor of Science, or equivalent experience
~ Institutional Review Board, Protocol Review Monitoring Committee, Data Safety Monitoring Board, Institutional Biosafety, Radiation Safety Committee, and Epidemiology Infectious Prevention.
~ Ability to work collegially and cooperatively in a small office and to establish and maintain cooperative working relationships
~ Ability to think critically, compiles data from various sources, analyze data, and prepare reports.
~ Ability to perform ongoing needs analysis and recommend solutions to resolve concerns.
~ Ability to prioritize assignments and achieve high productivity/quality with short time frames, under rigid deadlines, and /or in environments with frequent workload changes and competing demands
~ Working knowledge of computer software including Microsoft Office (Outlook, Word, Excel, and PowerPoint

National Group, Industrial, and Investigator-authored.
May require travel to satellite sites.

The University of California, Irvine (UCI) seeks to provide a safe and healthy environment for the entire UCI community.

Legal Right to work in the United States
Smoking and Tobacco Policy
The following additional conditions may apply, some of which are dependent upon business unit or job specific requirements.
~ California Child Abuse and Neglect Reporting Act


All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC nondiscrimination policy .

Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming.
UCI provides reasonable accommodations for applicants with disabilities upon request.

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