Senior Regulatory Coordinator

Job Description - Senior Regulatory Coordinator (10034573) Job Description Senior Regulatory Coordinator - ( 10034573 ) Description 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. Qualifications 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 setting OR Bachelor’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, please CLICK HERE . Primary Location : US-Nationwide-USA-Remote-US-Remote Job : Clinical Trials Operations Work Force Type : Remote Shift : Days Job Posting : May 7, 2026 Minimum Hourly Rate ($) : 44.903100 Maximum Hourly Rate ($) : 69.599300