Clinical Trial Startup Implementation Officer

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.

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 clinicrelated 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.

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, Power Point, 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.

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

Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, 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), and paid parental leave (up to 4 weeks).

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to Human Resources at hrops@fredhutch.org or by calling 206-667-4700.