Clinical Trial Startup Implementation Officer

Fred Hutch Cancer Center; Seattle (WA); Hybrid; USD 110,000 - 150,000; Full time

Job summary

Fred Hutchinson Cancer Center in Seattle seeks a Startup Implementation Officer to lead operational implementation of new clinical research protocols and amendments. You will translate protocol requirements into feasible, compliant workflows that support safe study activation and sustained conduct.

Collaborating with investigators, study teams, and service areas, you will develop execution plans, train staff, and ensure alignment with institutional policies to promote patient safety and

Qualifications

• Bachelor's degree required.
• Experience in clinical research operations or related field preferred.
• Strong collaboration and communication with multi-disciplinary teams.

Responsibilities

• Lead review of new clinical research protocols for feasibility and compliance.
• Develop implementation plans with clinical and operational leaders.
• Coordinate patient and research flow for new trials and ensure protocol adherence.
• Create study-specific education plans and materials for staff and clinicians.
• Bridge research and clinical operations to support protocol activation and execution.

Skills

Project management

Clinical research

Workflow design

Stakeholder collaboration

Training development

Education

Bachelor's degree

Job description

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 Implementation Officer role leads the operational implementation of new clinical research protocols and amendments. The role assumes responsibility for representing research visit flows at Fred Hutch & UW in close partnership with clinical and operational leaders across the enterprise. This role is responsible for translating protocol requirements into feasible, compliant, and executable workflows that support safe, efficient study activation and sustained protocol conduct. Key examples of responsibilities include detailed protocol review for new studies and amendments to existing studies, collaborating with research study teams (including Principal Investigators) and service areas to identify and resolve issues, reviewing orders, and developing study specific tools & training for both study teams and clinical service area staff.

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 role will have the opportunity to work partially at our campus and remotely.

Responsibilities

• Leads review of all new clinical research protocols and modifications to existing protocols for clinical and operational feasibility, drives detailed implementation planning, in collaboration with clinical /operational leaders by co-developing implementation plans and driving solutions for start-up and workflow concerns.
• In partnership with study team and service areas, develops and drives patient and research flow for new clinical trials ensuring all protocol requirements are met.
• Partners with faculty investigators, study team members and clinical and operational leadership to ensure there is alignment and preparedness for research protocols for enrollment to mitigate potential operational challenges.
• Prepares & disseminates summary of study procedures occurring in the clinical setting.
• Prepares and socializes concise summaries of study procedures occurring in the clinical setting, to ensure clarity and feasibility.
• Drives facilitation & coordination with all relevant clinic areas to vet protocol requirements and patient and research flow for new trials.
• Develops study specific education plan and educational materials specific to clinical & study staff; by partnering with clinical educators and other operational leaders to support clinical readiness for protocol implementation.
• Partners with clinical and operational leaders to interpret, communicate, and inform on institutional policies and procedures that support protocol compliance, patient safety, and efficient clinical operations.
• Collaborate with Principal Investigators, study teams, and clinical and operational leaders to anticipate and resolve clinic‑related barriers to protocol activation and sustained execution.
• Works collaboratively with all members of the study team and clinic teams.
• Communicates effectively with colleagues and other healthcare team members.
• Supports development and maintenance of clinical trials reference materials ("Knowledge Hub").
• Supports development of research orders from drafting through approval.
• Convenes and facilitates regular implementation meetings with clinical and operational leaders to review upcoming studies, obtain feedback on proposed workflows, and close the loop on issues identified during trial start up and conduct.
• Serves as a bridge between research and clinical operations, translating protocol requirements into workable processes co designed with clinical, nursing, and operational leadership teams.

Qualifications

MINIMUM QUALIFICATIONS:

Bachelor'