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#10031795 STERILE PROCESSING TECHNICIAN - EVE
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Anywhere, USA
SENIOR REGULATORY COORDINATOR - 10034573
Anywhere, USACity of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases.
Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope’s translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies and numerous breakthrough cancer drugs are based on technology developed at the institution. AccessHope™, a wholly owned subsidiary, was launched in 2019 and is dedicated to serving employers and their health care partners by providing access to City of Hope’s exceptional cancer expertise.
A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nation’s “Best Hospitals” in cancer by U.S. News & World Report and received Magnet Recognition from the American Nurses Credentialing Center. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona.
Pay Rate: $44.9 - $69.6 per hour
Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today.
Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today.
Under the direction of the Manager, Post-Activation Regulatory Support Services Senior Regulatory Coordinators lead Regulatory Support Services teams and other research teams through day-to-day questions. The Senior Regulatory Coordinator provides mentoring and training to staff (new and on-going) and to COH teams outside of RSS, as a lead representative of the department. The Senior Regulatory Coordinator guides teams through audit preparation, attends audit exit meetings, and collaborates with SCT Quality Assurance team. The Senior Regulatory Coordinator may assist with drafting Correction and Preventative Action Plans. The Senior Regulatory Coordinator assists Managers with tracking departmental metrics and Key Performance Indicators and following up with Regulatory Coordinators and Associate Regulatory Coordinators. The Senior Regulatory Coordinator facilitates protocol-related submissions such as continuing reviews, amendments and clarifications to applicable research regulatory oversight committees including but not limited to: IRB, C/PRMC, RSC, and IBC. To prepare for committee submissions, Senior Regulatory Coordinators are responsible for liaising with study team members to obtain relevant documents and study-related updates required for review and completion of the committee applications. Senior Regulatory Coordinators also serve as a liaison to regulatory committees and external sponsors. Senior Regulatory Coordinators are also responsible for working with investigators and sponsors to address regulatory oversight committee conditions and requests for information.
Senior Regulatory Coordinators play a significant role in supporting studies through the life of the trial and maintaining the regulatory binder. Senior Regulatory Coordinators must have knowledge of institutional policies and SOPs, GCP and OHRP practices and federal and state regulations. Senior Regulatory Coordinators lead and participate in workgroups for process and system improvements to enhance department operations.
As a successful candidate, you will:
- Leads regulatory oversight for clinical trials, including preparation and submission of amendments, continuing reviews, safety reports, deviations, and study close-out documentation to IRB, DSMC, PRMC, IBC, and other regulatory committees while ensuring compliance with institutional and federal guidelines.
- Maintains accurate and audit-ready electronic regulatory binders and essential study documents, ensuring ongoing compliance with GCP, protocol requirements, regulatory standards, and internal policies during monitoring visits and external audits.
- Serves as a primary regulatory liaison between investigators, research teams, sponsors, CROs, and regulatory agencies, facilitating timely protocol approvals, resolving study-related questions, and communicating submission status updates to key stakeholders.
- Provides regulatory expertise and operational guidance to investigators and research staff by leading onboarding, training, educational sessions, and development of reference materials related to clinical trial policies, procedures, and compliance requirements.
- Collaborates with legal teams, sponsors, and study personnel to review informed consent documents, ensure consistency in institutional and contractual language, and implement protocol and staffing updates as required.
- Participates in departmental meetings, process improvement initiatives, and cross-functional workgroups to enhance regulatory operations, strengthen compliance practices, and support efficient clinical research program execution.
Your qualifications should include:
Minimum Education & Minimum Experience: Associates degree and 5 years of experience related to the management and conduct of clinical trials in an academic settingORBachelor’s degree and 3 years of experience related to the management and conduct of clinical trials in an academic setting. Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form and protocol development.
City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location.
City of Hope is an equal opportunity employer.
To learn more about our Comprehensive Benefits, pleaseCLICK HERE.






