Remote Regulatory Startup Lead for Clinical Trials

Fred Hutchinson Cancer Research Center; Seattle (WA); Remote; USD 99,000 - 157,000; Full time

Benefits offered by this job

Medical & vision

Dental

Retirement plans

Paid vacation

Sick leave

Paid holidays

Paid parental leave

Tuition reimbursement

Onsite health clinic

Job summary

Fred Hutchinson Cancer Center in Seattle, WA, is seeking a Startup Regulatory Operations Manager to oversee regulatory startup activities for a portfolio of studies. The role serves as a liaison among investigators, sponsors, IRBs, and regulatory agencies to ensure compliance and timely study activation.

You will lead regulatory processes, training, document management, risk mitigation, and efficiency initiatives, while coaching regulatory staff and coordinating with cross-functional teams in a

Qualifications

• Bachelor’s degree or equivalent combination of education and experience.
• 5+ years of clinical research experience, including regulatory 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.

Responsibilities

• 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.
• 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.
• 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.
• 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.

Skills

Regulatory operations

Leadership

Project management

Regulatory submissions

GCP compliance

IRB coordination

FDA regulations

Communication

Education

Bachelor’s degree

Tools

Florence eBinders

Veeva

CTMS

REDCap

Job description

Fred Hutchinson Cancer Center in Seattle, WA, is seeking a Startup Regulatory Operations Manager to oversee regulatory startup activities for a portfolio of studies. The role serves as a liaison among investigators, sponsors, IRBs, and regulatory agencies to ensure compliance and timely study activation.

You will lead regulatory processes, training, document management, risk mitigation, and efficiency initiatives, while coaching regulatory staff and coordinating with cross-functional teams in a