Regulatory Coordinator III - Hybrid

Cedars-Sinai Medical Center•West Hollywood, CA

3d•Hybrid

About The Position

This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable area. The Regulatory Coordinator III will provide supervision of other regulatory staff. Prepares and submits protocols and supporting documents to regulatory bodies such as PPC, PRMC, IBCS, Cedars-Sinai IRB, External IRB and IACUC. This role submits continuations, amendments, responds to questions, generates reports, and maintains files research files and documentation involving the regulatory requirements for the study/clinical trial. Other duties include, representing the Medical Center when meeting with pharmaceutical companies, attending weekly team meetings, and working with other staff to insure all regulatory documents and requirements are met and up-to-date. May plan and coordinate strategies for improving efficiency, action plans to improve quality, or training and education of personnel. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). Primary Duties and Responsibilities Oversees daily activities and provided supervision of regulatory staff, including Regulatory Coordinator I and II and assists with coverage as needed. Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC. Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies. Responds to all questions from the IRB or IACUC related to the regulatory aspects of the study. Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies. Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials. Meets with monitors from sponsors and represents the Cancer Center during these meetings. Works closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date. Attends research team meetings and updates staff and investigators on the status of regulatory submission and amendments. May participate in internal auditing of regulatory documents. Participates in required training and education programs and may provide training and education of other personnel. May participate in centralized activities of the department and/or institution. May plan and coordinate strategies to improve existing standard operating procedures related to regulatory affairs. May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA), Institutional Review Board(s), Good Clinical Practices (GCP) and HIPAA standards. Department specific duties: Oversees and coordinates all regulatory activities for projects managed by the Translational Research Concierge (TRC) group. Independently prepares and manages regulatory submissions, including: New study submissions, Protocol modifications, Continuing reviews/renewals, Adverse event reporting, and Study closures. Submits and manages regulatory documents with the Institutional Review Board (IRB), Food and Drug Administration (FDA), Protocol Review and Monitoring Committee (PRMC), and other ancillary review committees. Drives protocols through the regulatory review process to ensure timely approvals and efficient clinical trial activation. Serves as the primary regulatory lead for assigned clinical research protocols. Acts as a liaison between sponsors, regulatory agencies, pharmaceutical companies, and research partners, facilitating clear verbal and written communication. Maintains accurate and compliant regulatory documentation in OnCore and other clinical trial management systems and databases. Conducts patient chart reviews, eligibility screening, and informed consent processes, as needed. Supports the development of study workflows to facilitate clinical research implementation, trial activation, and study closeout. Thrives in a deadline-driven environment while maintaining flexibility and adapting to evolving institutional priorities. Demonstrates initiative, accountability, and a strong commitment to regulatory compliance and ethical research practices. Develops and maintains Standard Operating Procedures (SOPs), workflows, and regulatory guidelines. Leads project management activities from study activation through protocol implementation. Assists with study budget development and coordination with sponsors, as needed.

Requirements

BA/BS degree required.
Minimum of five (5) years of directly related regulatory experience supporting clinical research studies.
Must reside in a commutable area to Los Angeles work location.

Nice To Haves

Ability to thrive in a deadline-driven environment while maintaining flexibility and adapting to evolving institutional priorities.
Demonstrates initiative, accountability, and a strong commitment to regulatory compliance and ethical research practices.

Responsibilities

Provide supervision of other regulatory staff.
Prepare and submit protocols and supporting documents to regulatory bodies such as PPC, PRMC, IBCS, Cedars-Sinai IRB, External IRB and IACUC.
Submit continuations, amendments, respond to questions, generate reports, and maintain files research files and documentation involving the regulatory requirements for the study/clinical trial.
Represent the Medical Center when meeting with pharmaceutical companies.
Attend weekly team meetings.
Work with other staff to insure all regulatory documents and requirements are met and up-to-date.
Plan and coordinate strategies for improving efficiency, action plans to improve quality, or training and education of personnel.
Ensure compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Oversee daily activities and provide supervision of regulatory staff, including Regulatory Coordinator I and II and assist with coverage as needed.
Submit continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies.
Respond to all questions from the IRB or IACUC related to the regulatory aspects of the study.
Complete forms and generate all reports necessary to comply with regulatory requirements and institutional policies.
Establish and maintain research files and documentation pertaining to regulatory requirements for clinical trials.
Meet with monitors from sponsors and represent the Cancer Center during these meetings.
Work closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.
Update staff and investigators on the status of regulatory submission and amendments.
Participate in internal auditing of regulatory documents.
Participate in required training and education programs and may provide training and education of other personnel.
Participate in centralized activities of the department and/or institution.
Plan and coordinate strategies to improve existing standard operating procedures related to regulatory affairs.
Identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
Ensure compliance with all federal and local agencies including the Food and Drug Administration (FDA), Institutional Review Board(s), Good Clinical Practices (GCP) and HIPAA standards.
Oversee and coordinate all regulatory activities for projects managed by the Translational Research Concierge (TRC) group.
Independently prepare and manage regulatory submissions, including: New study submissions, Protocol modifications, Continuing reviews/renewals, Adverse event reporting, and Study closures.
Submit and manage regulatory documents with the Institutional Review Board (IRB), Food and Drug Administration (FDA), Protocol Review and Monitoring Committee (PRMC), and other ancillary review committees.
Drive protocols through the regulatory review process to ensure timely approvals and efficient clinical trial activation.
Serve as the primary regulatory lead for assigned clinical research protocols.
Act as a liaison between sponsors, regulatory agencies, pharmaceutical companies, and research partners, facilitating clear verbal and written communication.
Maintain accurate and compliant regulatory documentation in OnCore and other clinical trial management systems and databases.
Conduct patient chart reviews, eligibility screening, and informed consent processes, as needed.
Support the development of study workflows to facilitate clinical research implementation, trial activation, and study closeout.
Develop and maintain Standard Operating Procedures (SOPs), workflows, and regulatory guidelines.
Lead project management activities from study activation through protocol implementation.
Assist with study budget development and coordination with sponsors, as needed.