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. These values are grounded in and expressed through the principles of diversity, equity and inclusion. 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. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

The Clinical Research Coordinator II is responsible for the day-to-day coordination of pediatric clinical research studies aimed at bringing innovative new treatment options to our pediatric patients. The pediatric research program is cross-institutional with research activities taking place at Fred Hutch and at Seattle Children's Hospital. The unique cross-institutional model offers dynamic opportunities to work with multi-disciplinary teams across the Fred Hutch/University of Washington/Seattle Children's Cancer Consortium. Based at Fred Hutch the Clinical Research Coordinator will serve as an integral member of the pediatric research program to manage bone marrow transplant, gene therapy and other pediatric clinical trials from start-up to close-out.

This role will have the opportunity to work partially at our campus and remotely. Travel from Fred Hutch to Seattle Children's may be required.

Cover letters are optional but highly encouraged.

Responsibilities

• Provide day-to-day coordination of oncology clinical trials within Fred Hutch and Seattle Children's setting including, screening patients for protocol eligibility, ensuring informed consent has been properly obtained, enrolling subjects, collecting data, and communicating with clinic staff.
• Collaborate with clinic providers and staff, ancillary services, and research staff regarding protocol implementation and operations.
• Liaise between Fred Hutch and Seattle Children's departments and staff to facilitate cross-site research activities including study start-up and initial implementation.
• Initiate scheduling of participant clinic visits and on-going study visits. As needed, attend participant visits, and ensure clinical procedures, lab tests, and other protocol specific activities are completed as outlined in the protocols.
• Complete requisition forms, assemble kits for upcoming research visits, transport laboratory samples, and ensure samples are processed and shipped according to study specific guidelines, while tracking and maintaining research supplies
• Perform data collection, abstraction and reporting from and into multiple data management systems.
• Serve as liaison for Investigational Drug Services (IDS) on drug assignment, dispensation information, and maintain regular communication regarding status of study participant.
• Identify, and report adverse events in accordance with protocol, regulatory guidelines, and institutional policy
• Manage protocol, regulatory files and study related activity in the IRB, eReg, CTMS and other systems, including dual submission and management of some studies in separate but similar platforms.
• Coordinate research protocol monitoring and auditing visits and take action to correct problems such as deviation from protocol requirements to ensure research quality.
• Respond to data queries and other requests from data coordinators and study monitors in a timely manner.
• Provide back-up for other Clinical Research Coordinators as needed. Provide back up for Data Coordinator on applicable trials.
• Other duties as assigned.

Qualifications

MINIMUM QUALIFICATIONS:

• High School Diploma
• Minimum two years' experience working in clinical research
• Knowledge of FDA regulations, GCP guidelines, Human Subjects protections and other applicable regulations
• Ability to work independently and prioritize work in a dynamic environment
• Collaborative and skilled working across multidisciplinary interinstitutional teams including clinical teams
• Resourceful and able to solve problems, yet seek guidance when needed
• Comfortable working in clinic setting and interacting with patients, including children
• Strong attention to detail and ability to work according to Standard Operating Procedures (SOPs)
• Exceptional interpersonal skills both in-person and on telephone calls
• Strong written and verbal communication skills
• Travel between the Fred Hutch south lake union campus and Seattle Children's Hospital is required

PREFERRED QUALIFICATIONS:

• Bachelor's degree
• Experience in pediatric or oncology trials strongly preferred
• Clinical research-related professional certification
• Experience working with electronic medical records (EMR) and a clinical trial management system (CTMS)

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

The hourly pay range for this position is from $31.21 to $46.80 and pay offered will be based on experience and qualifications. 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), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).

Our Commitment to Diversity