Regulatory Assistant

Fred Hutchinson Cancer Center•Seattle, WA

About The Position

The Regulatory Assistant provides administrative and regulatory support for the activation, maintenance, monitoring, and closeout of clinical research studies as part of the eRegulatory Support team. The role supports Regulatory Coordinators and study teams by maintaining regulatory documentation, preparing submissions, tracking regulatory requirements, and ensuring study records are complete and audit-ready. The Regulatory Assistant works with investigators, research staff, sponsors, IRBs, and institutional committees to support compliant study conduct in accordance with federal regulations, institutional policies, and Good Clinical Practice (GCP) guidelines. The position also provides first-level support for electronic regulatory systems and applications, including Florence eBinders and eConsent. It provides instructions for team training and access, triages support requests, and escalates technical or workflow issues as needed. Most Fred Hutch jobs require some on-campus work, although there may be flexibility for certain positions; applicants interested in working only outside the Seattle area are advised to check with the recruiter. Fred Hutchinson Cancer Center is an independent nonprofit organization providing adult cancer treatment and conducting research focused on cancer and infectious diseases. Based in Seattle, it is Washington’s only National Cancer Institute-designated cancer center and operates eight clinical care sites, with network affiliations with hospitals in five states. Its mission is to discover new cures for serious diseases and make life beyond cancer a reality. Employees are expected to demonstrate collaboration, compassion, determination, excellence, innovation, integrity, and respect.

Requirements

High school diploma or equivalent combination of education and experience.
Ability to organize, manage, and maintain complex documentation.
Strong attention to detail and ability to perform quality review of records and documents.
Ability to manage competing priorities and adapt to changing business needs.
Ability to maintain confidentiality and exercise sound judgment.
Ability to communicate and collaborate effectively and provide customer support in a predominantly remote work environment.
Proficiency in Word, SharePoint, Excel, Acrobat, and OneDrive.

Nice To Haves

Six months or more of experience in an administrative support position.
Experience in a research, healthcare, or regulated environment.
Familiarity with clinical research, human subject protections, or regulatory compliance processes.
Experience reviewing, organizing, or maintaining compliance-related documentation.
Experience with clinical trial management systems or electronic regulatory document platforms.
Experience in an oncology or academic research setting.

Responsibilities

Assist Regulatory Coordinators with regulatory startup, maintenance, continuing review, amendment, and study closeout activities for designated research teams.
Gather and prepare required regulatory documents and site information to support study startup and activation.
Assist with regulatory correspondence and maintain regulatory documentation in accordance with institutional procedures.
Support documentation related to safety report review and regulatory reporting requirements.
Respond to routine information requests from Regulatory Coordinators, study teams, and institutional offices, escalating complex regulatory issues and contingencies as appropriate.
Maintain study regulatory files and binders so documentation is complete, current, and audit-ready.
Ensure investigator and study staff credentialing is maintained and filed appropriately.
Manage protocol-specific training records and study personnel delegation documentation.
Enter and maintain accurate study information in regulatory and clinical trial management systems, including electronic regulatory platforms.
Perform quality checks to identify missing, expired, or incomplete documentation.
Assist in preparing materials for monitor visits, audits, and regulatory inspections.
Assist Regulatory Coordinators with tracking and documenting corrective actions related to routine monitoring findings.
Report potential compliance concerns to Regulatory Coordinators and management.
Participate in quality improvement initiatives and departmental process improvement activities.
Support collection and reporting of departmental metrics and operational data.
Serve as a resource for routine regulatory document and process questions and collaborate with investigators, study teams, and departmental partners to support study activation and maintenance.
Monitor and respond to inquiries received through shared departmental communication channels.
Maintain effective working relationships with internal and external stakeholders and provide timely, professional customer service to investigators, research personnel, sponsors, and institutional offices.
Participate in departmental meetings, training activities, and team projects.
Provide instructions for training and access to Florence eBinders and eConsent.
Provide first-level support for electronic regulatory systems and applications, escalating technical or workflow issues as appropriate.
Review and file Cancer Consortium staff credential and training documents, and notify staff of upcoming document expirations and renewal tracking.
Triage and respond to inbox requests for technical support and information about Florence eBinders and eConsent, escalating as needed.