Sr. Clinical Research Operations Specialist

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.

We are actively expanding our central research teams to support Principal Investigators (PIs) and study teams who are focused on mission-critical clinical trials programs. The Sr. Clinical Research Operations Specialist will be primarily responsible for project managing clinic implementation activities to help ensure all clinical trial implementation gaps and issues for a study are identified and addressed in a timely manner until the trial is open to enrollment, and then subsequently project manage clinical trial implementation of amendments through the life cycle of the study.

The role is a key member of the Clinical Readiness Team within the Fred Hutch Clinical Research Support Department, and actively collaborates with Clinical Trial Nurses, pharmacists, clinical service areas and research teams in driving implementation activities. This is a high-growth opportunity that allows for learning & impact in a variety of dimensions including cutting edge clinical trial operations, process improvement, technology tools and data-driven decision making.

Most Fred Hutch jobs require some on-campus work. However, there may be flexibility for certain positions. Please check with the recruiter if you are an out-of-state applicant interested only in working outside of the Seattle area.

Responsibilities

* Track & manage a portfolio of 20+ clinical trials.

* Set goals and timetables for each trial submitted to the Clinic Readiness team, ensuring that all clinic implementation activities related to study startup are completed.

* Using standard tools & templates, maintain and track detailed project plan & issues tracker for clinic implementation activities from pre-submission support to open to accrual;
Subsequently support clinic implementation project management of amendments through the lifecycle of a study.

* Anticipate issues & barriers to study implementation and lead proactive steps to resolve issues & barriers.

* Lead multi-disciplinary project teams interacting with many different levels of staff within Clinical Research Support & other departments at Fred Hutch & UW

* Effectively use written and oral communication skills. This includes exceptional note taking, maintaining clear, concise project management documents.

* Serve as study liaison, representing the study to other Center departments from a clinic implementation perspective. Give presentations as necessary.

* Analyze and apply expertise related multiple complex clinical trial protocols & associated documents.

* Draw out key information to help identify how research will be integrated into clinic activities.

* Call out areas and influence solutions where additional operational workflow/training are needed to accommodate protocol activities and identify implementation barriers.

* Troubleshoot any areas where documents are inconsistent or require additional clarification and define pathways to resolution.

* Serve as subject matter expert on operational practices at Fred Hutch and UW to help identify where specific protocols may not adhere to standard operating practices and require additional process analysis before they can be implemented.

* Lead stakeholder meetings, prepping agendas and pre-read materials, collecting & synthesizing inputs, guiding discussions in a solution-oriented way, documenting minutes, and following up on action items.

* Provide timely & accurate updates on status to customers and leadership.

* Organize and manage time and tasks independently.

* Continually advocate, identify & lead process improvement efforts.

* Work with a variety of systems and tools including project management tools such as Smartsheet, ticketing systems such as Zendesk,…