Research Manager, Startup Regulatory Operations

Fred Hutchinson Cancer Center (Fred Hutch); Seattle (WA); Remote; USD 99.000 - 157.000; Vollzeit

Benefits dieser Stelle

Comprehensive benefits

Paid time off

Tuition reimbursement

Onsite health clinic

Zusammenfassung

Fred Hutchinson Cancer Center in Seattle, WA, invites applications for Startup Regulatory Operations Manager, responsible for overseeing regulatory startup activities to activate clinical studies. You will coordinate documentation, trainings, and regulatory submissions, serving as liaison among investigators, sponsors, IRBs, regulators, and study teams.

The role leads regulatory processes, ensures compliance with FDA, ICH-GCP, and institutional policies, and drives startup timelines.

Qualifikationen

• Bachelor's degree or equivalent combination of education and experience.
• 5+ years of clinical research experience, including regulatory operations and startup.
• At least 2 years in leadership or supervision.
• Experience with regulatory submissions, IRBs, sponsors, and FDA regulations.
• Strong project management and organizational skills.
• Excellent verbal and written communication skills.

Aufgaben

• Lead regulatory startup and activation activities for multiple studies and ensure documentation, approvals, and training are in place.
• Monitor milestones, identify risks, and implement mitigations to meet activation timelines.
• Ensure regulatory compliance through review of protocols, consents, and essential documents, and support audits.
• Develop regulatory startup strategies and drive process improvements for efficiency.
• Act as primary regulatory liaison to investigators, sponsors, CROs, and stakeholders.
• Coach and develop regulatory staff and manage workload and performance.

Kenntnisse

Leadership experience

Project management

Regulatory knowledge

Communication skills

Ausbildung

Bachelor's degree or equivalent

Tools

FDA regulations

GCP compliance

IRB coordination

CTMS/eBinders familiarity

Jobbeschreibung

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 Startup Regulatory Operations Manager is responsible for overseeing and coordinating regulatory startup activities to support the timely activation of clinical research studies. This role serves as a key liaison among investigators, sponsors, research teams, institutional review boards (IRBs), regulatory agencies, ancillary departments, and institutional stakeholders to ensure regulatory compliance and operational readiness during study startup.

The position provides strategic and operational leadership for regulatory processes, including protocol review, regulatory submissions, study activation requirements, investigator and site documentation management, regulatory training compliance, and startup workflow optimization. The individual ensures adherence to federal regulations, Good Clinical Practice (GCP), institutional policies, sponsor requirements, and applicable research standards while supporting efficient study activation and enrollment timelines.

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

This is a remote position.

Job Details

Job ID: 31848

Type: Regular Full-Time

Location: US-WA-Seattle

Category: Clinical Research Support Services

Responsibilities

Regulatory Startup & Study Activation

• Lead regulatory startup and activation activities for a portfolio of industry-sponsored and investigator-initiated studies, coordinating required documentation, approvals, training, system access, and cross-functional startup activities.
• Monitor startup performance metrics, regulatory milestones, and activation timelines; identify risks and implement mitigation strategies to achieve departmental service-level expectations and accelerate study activation.

Regulatory Compliance & Quality Oversight

• Ensure regulatory compliance through review and collection of protocols, informed consents, Investigator's brochures, regulatory files, essential documents, investigator credentials, training records, and study documentation.
• Maintain inspection readiness and support audits, monitoring visits, quality assurance activities, and implementation of regulatory systems and document management processes.

Operational Excellence & Stakeholder Engagement

• Develop and implement regulatory startup strategies, standardized processes, best practices, and continuous improvement initiatives to enhance efficiency and reduce activation timelines.
• Serve as the primary regulatory liaison for investigators, sponsors, CROs, research teams, and institutional stakeholders, communicating progress, risks, and escalation items while fostering effective collaboration.

Leadership & Team Development

• Manage, coach, and develop regulatory staff through hiring, onboarding, performance management, workload oversight, and professional development.
• Establish team goals, performance standards, and accountability measures while promoting a culture of compliance, operational excellence, and continuous improvement.
• Lead resource planning, workload distribution, and prioritization strategies to ensure appropriate support for startup activities across the study portfolio.
• Champion adoption of new technologies, regulatory processes, and organizational initiatives to support operational scalability and continuous improvement.

Qualifications

MINIMUM QUALIFICATIONS

• Bachelor's degree or equivalent combination of education and experience.
• 5+ years of clinical research experience, including significant experience in regulatory operations, regulatory affairs and regulatory startup operations.
• At least 2 years of leadership, supervisory or team lead experience.
• Experience supporting regulatory submissions and study startup activities.
• Experience working with IRBs, sponsors, CROs, FDA regulations, and GCP requirements.
• Strong project management and organizational skills.
• Excellent verbal and written communication skills.
• Ability to interpret clinical protocols and regulatory guidance documents.
• Excellent organizational, project management, attention to detail and problem-solving skills.
• Ability to manage multiple studies and competing priorities within aggressive timelines.

PREFERRED QUALIFICATIONS

• Direct experience with Investigator-initiated trials.
• Demonstrated success leading, coaching, and developing geographically dispersed teams in a remote or hybrid work environment, including performance management, employee engagement and change leadership.
• Comprehensive knowledge of FDA regulations, ICH-GCP guidelines, OHRP requirements, and human subjects protection regulations.
• Startup regulatory management experience across both industry and non-industry studies.
• Florence eBinders, Veeva, CTMS, REDCap expertise.
• RAC, CCRP, CCRC, ACRP, CIP certifications.

The annual base salary range for this position is from $99,486 to $157,227, 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 [e-mail] or by calling 206-667-4700.