Clinical Trial Startup Implementation Officer

Fred Hutchinson Cancer Center•Seattle, WA

12d•Hybrid

About The Position

The Clinical Trial Startup Implementation Officer leads the operational implementation of new clinical research protocols and amendments. The role represents research visit flows at Fred Hutch and UW in close partnership with clinical and operational leaders across the enterprise. It translates protocol requirements into feasible, compliant, and executable workflows that support safe, efficient study activation and sustained protocol conduct. The Officer reviews protocols, collaborates with study teams and service areas to identify and resolve issues, reviews and supports development of research orders, and creates study-specific tools and training for study teams and clinical service area staff. The role serves as a bridge between research and clinical operations, ensuring teams are aligned and prepared for protocol enrollment and execution. The position may be performed partially on campus and remotely.

Requirements

Bachelor’s degree in nursing or a related field.
At least 2 years of experience in oncology in an academic or hospital setting.
Demonstrated experience interpreting clinical trial protocols and applying requirements to operational workflows, order development, or clinical implementation planning.
Demonstrated ability to work effectively across interdisciplinary teams and coordinate stakeholders with differing operational priorities.
Strong analytical, critical-thinking, problem-solving, and organizational skills, including the ability to manage competing priorities and meet deadlines.

Nice To Haves

Experience supporting startup, activation, or implementation of oncology clinical trials in an academic medical center or hospital-based setting.
Experience with oncology research orders, treatment plans, or order sets in Epic.
Knowledge of clinical workflow design, protocol operationalization, and readiness planning in oncology settings.
Process improvement experience and ability to identify workflow gaps and implement practical solutions.
Demonstrated ability to work effectively as a member of an interdisciplinary team.
Ability to work to deadlines and targets.
Experience in the care of oncology patients.
Proficiency with Microsoft Office applications, including Word, PowerPoint, Excel, Outlook, and Teams.
Strong written and verbal communication skills.
Certification in clinical research (e.g., ACRP or SOCRA) or related advanced training in clinical research management.

Responsibilities

Lead review of new clinical research protocols and modifications to existing protocols for clinical and operational feasibility.
Drive detailed implementation planning with clinical and operational leaders, co-developing implementation plans and resolving study-startup and workflow concerns.
Develop and drive patient and research workflows for new clinical trials with study teams and service areas, ensuring protocol requirements are met.
Partner with faculty investigators, study team members, and clinical and operational leadership to align teams and prepare for enrollment while mitigating operational challenges.
Prepare and disseminate concise summaries of procedures occurring in clinical settings.
Coordinate with relevant clinic areas to review protocol requirements and patient and research flows for new trials.
Develop study-specific education plans and materials for clinical and study staff in partnership with clinical educators and operational leaders.
Partner with clinical and operational leaders to interpret, communicate, and inform on institutional policies and procedures supporting protocol compliance, patient safety, and efficient clinical operations.
Work with Principal Investigators, study teams, and clinical and operational leaders to anticipate and resolve clinic-related barriers to protocol activation and sustained execution.
Communicate and collaborate effectively with study teams, clinic teams, colleagues, and other healthcare team members.
Support development and maintenance of clinical trials reference materials, including the Knowledge Hub.
Support development of research orders from drafting through approval.
Convene and facilitate regular implementation meetings with clinical and operational leaders to review upcoming studies, gather workflow feedback, and resolve issues identified during trial startup and conduct.
Translate protocol requirements into workable processes co-designed with clinical, nursing, and operational leadership teams.