Clinical Trial Startup Implementation Officer

About the role

The Startup Implementation Officer leads the operational implementation of new clinical research protocols and amendments at Fred Hutchinson Cancer Center. This role represents research visit flows across Fred Hutch and UW in close partnership with clinical and operational leaders, translating protocol requirements into feasible, compliant, and executable workflows that support safe, efficient study activation and sustained protocol conduct. Key activities include detailed protocol review for new studies and amendments, collaborating with research study teams (including Principal Investigators) and service areas to identify and resolve issues, reviewing orders, and developing study‑specific tools and training for both study teams and clinical service area staff. The position offers a hybrid schedule with partial on‑campus and remote work.

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 teams 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 alignment and preparedness for research protocols for enrollment to mitigate potential operational challenges.
• Prepares and disseminates summaries of study procedures occurring in the clinical setting to ensure clarity and feasibility.
• Drives facilitation and coordination with all relevant clinic areas to vet protocol requirements and patient/research flow for new trials.
• Develops study‑specific education plans and educational materials for clinical and study staff; partners with clinical educators and 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.
• Collaborates 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’s degree in nursing or related field.
• At least 2 years of experience in Oncology in an academic or hospital setting.
• Demonstrated experience interpreting clinical trial protocols and applying protocol requirements to operational workflows, order development, or clinical implementation planning.
• Demonstrated ability to work effectively across interdisciplinary teams and to coordinate stakeholders with differing operational priorities.
• Strong analytical, critical thinking, problem‑solving, and organizational skills, with the ability to manage multiple competing priorities and meet deadlines.

Preferred Qualifications:

• 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.
• Demonstrated process improvement experience and ability to identify workflow gaps and implement practical solutions.
• Demonstrated ability to work as an effective member of an interdisciplinary team.
• Ability to successfully work to deadlines and targets.
• Experience in the care of oncology patients.
• Proficiency with Microsoft Office applications (Word, PowerPoint, Excel, Outlook, Teams).
• Strong written and verbal communication skills.
• Certification in clinical research (e.g., ACRP, SOCRA) or related advanced training in clinical research management.

Pay

The annual base salary range for this position is $107,079 to $169,228; 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.

Benefits

• Medical, vision, and dental insurance
• Flexible spending accounts
• Life and disability insurance
• Retirement plan
• Family life support and 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)
• Paid parental leave (up to 4 weeks)