Research Manager, Startup Regulatory Operations

Fred Hutchinson Cancer Center•Seattle, WA

30d•Remote

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.