Regulatory Assistant

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

The Regulatory Assistant provides administrative and regulatory support for the activation, maintenance, monitoring, and closeout of clinical research studies. The Regulatory Assistant 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 closely 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.

At Fred Hutchinson Cancer Center, all employees are expected to demonstrate a commitment to our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.

This position will be within the eRegulatory Support team.

Most Fred Hutch jobs require some on-campus work. However, there may be flexibility for certain positions. Please check with the recruiter if you are an out-of-state applicant interested only in working outside of the Seattle area.

Responsibilities

Regulatory Support & Study Administration:

- Assist Regulatory Coordinators with the regulatory startup, maintenance, continuing review, amendments, and study closeout activities for designated research teams.

- Support study startup and activation activities by gathering and preparing required regulatory documents and site information.

- Assist Regulatory Coordinators with processing regulatory correspondence and maintaining regulatory documentation in accordance with institutional procedures.

Institutional & External Reviews:

- Support maintenance of documentation related to safety report review and regulatory reporting requirements.

- Respond to routine requests for information from Regulatory Coordinators, study teams and institutional offices.

- Escalate complex regulatory issues and contingencies to Regulatory Coordinators or management.

Documentation & Systems:

- Maintain study regulatory files and binders, ensuring documentation is complete, current, and audit-ready.

- Ensure required investigator and study staff credentialing are maintained and filed appropriately.

- Manage protocol-specific training records and study personnel delegation documentation.

- Enter and maintain accurate study information within regulatory and clinical trial management systems, including electronic regulatory platforms.

- Perform quality checks of regulatory files to identify missing, expired, or incomplete documentation.

Compliance, Quality & Monitoring Support:

- Assist in preparing materials for monitor visits, audits, and regulatory inspections.

- Assist Regulatory Coordinators with tracking and documenting corrective actions associated with routine monitoring findings.

- Report potential compliance concerns to Regulatory Coordinators and management.

- Participate in quality improvement initiatives and department process improvement activities.

- Support the collection and reporting of departmental metrics and operational data

Collaboration & Communication:

- Serve as a resource for routine regulatory document and process questions.

- 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 to support efficient regulatory operations.

- Participate in departmental meetings, training activities, and team projects.

- Provide professional and timely customer service to investigators, research personnel, sponsors, and institutional offices.

eRegulatory Support:

- Provide instructions for training and access to teams using 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 expiration notices for documents and tracking renewals.

- Triage and respond to inbox requests for technical support and information related to using Florence eBinders and eConsent, escalating as needed.

Qualifications

MINIMUM QUALIFICATIONS:

- High school diploma or equivalent combination of education and experience required.

- Demonstrated 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 judgement.

- Ability to effectively communicate, collaborate, and provide customer support in a predominantly remote work environment. Proficiency in Word, SharePoint, Excel, Acrobat, OneDrive

PREFERRED QUALIFICATIONS:

- Six months or more of 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.

The hourly pay range for this position is from $25.72 to $36.62 and pay offered will be based on experience and qualifications.Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), and paid parental leave (up to 4 weeks).

## Additional Information
We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to Human Resources at [email protected] or by calling 206-667-4700.