Senior Regulatory Coordinator

Foundation

Senior Regulatory Coordinator overseeing regulatory compliance for clinical trials at City of Hope. Managing audit preparations, submissions, and acting as liaison between teams and regulatory bodies.

Posted 5/8/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $45 - $70 per hourWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

Health insurance
401(k) matching
Flexible work hours
Paid time off
Remote work options

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory oversightclinical trials managementGCP complianceprotocol developmentamendments preparationsafety reportsaudit readinesssubmission documentationmonitoring visitstraining and onboarding

Soft Skills

communicationcollaborationproblem-solvingleadershiporganizational skillsfacilitationeducational guidancestakeholder engagementprocess improvementcross-functional teamwork