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.

The Clinical Research Coordinator I-II works under the direction of the Clinic Operations Manager to provide onsite administrative and operational support for clinical research studies at the Vaccine Trials Unit (VTU). The candidate will be a proactive and self-motivated team member responsible for facilitating study participants' visits and assisting VTU staff in daily clinic operations. The candidate may assume additional responsibilities as they become more proficient in their job.

Please include a cover letter with your application describing your interest in this position.

Responsibilities

Clinical Research Coordinator I

• Assist clinicians with the day-to-day coordination of clinical research studies and study participant visits, including (subject to appropriate training/experience) performing phlebotomy, ECGs, vital signs, provision and labeling of tubes, and completion and verification of requisitions.
• Schedule and coordinate active study participants' visits within the required protocol timeframe and update appointment notes in a timely manner.
• Enter, submit, review and/or monitor clinical trial data utilizing both paper and electronic source documentation, and multiple electronic data capture (EDC) systems (e.g. REDCap, Medidata Rave, eClinical, and other sponsor-specific systems)
• Perform ongoing data quality control and routine data quality assurance to ensure quality and completeness of data submitted
• Monitor adherence to protocol data collection requirements, investigating any data deviations or violations
• Conduct data quality assurance activities
• Maintain ongoing contact with clinicians and others collecting data to ensure timely and complete reporting
• Assist in the establishment of timetables for data collection and processing tasks
• In conjunction with study clinicians, manage development of, and updates to, protocol-specific source documentation and protocol-specific charts for screening, enrollment, and follow-up of research participants
• File study materials and charts, copy and print materials needed for other staff members and overall clinical research activity.
• Coordinate sample deliveries to various labs at Fred Hutch and other collaborating institutions, including Harborview, UW Lab, Bloodworks NW, etc. Proactively and accurately update Outlook calendars and promptly respond to Microsoft Teams chats to ensure clear communication between clinic and lab personnel.
• Pack and process laboratory specimens and coordinate communications between labs and shipping companies.
• Accompany study participants to off-site locations where research procedures are conducted, including Bloodworks NW for leukapheresis and Harborview Medical Center for radiology services.
• Conduct quality control activities prior to, and after, the collection of laboratory specimens obtained for clinical testing and research assays.
• Maintain required training/certification related to research conduct and to specific research protocols as required by study sponsors.
• Participate in front desk reception and assist with upkeep of VTU
• Train, or assist with training, new employees and other VTU staff in duties related to front desk support.
• As needed, assist with scheduling and setup of study-related meetings.
• Participate in weekly staff meetings and assist in tracking agenda topics, recording of meetings and storing meeting recordings.
• Maintain and update administrative duties as outlined in the Operations Manual.
• Other duties as assigned.

Clinical Research Coordinator II

All responsibilities of a Clinical Research Coordinator I, plus:

• Assist clinicians with mucosal biopsy collection, including coordination of visit-scheduling and on-site procedural assistance and sample processing.
• Schedule and track maintenance and calibration of equipment utilized for clinical visits and procedures.
• Coordinate front desk reception and assist with upkeep of VTU suite, including implementation of the building's emergency operating procedures.
• Order, track and organize supplies for the clinic and recruitment supplies for study participants. Conduct regular inventory management.
• Provide fiscal support by compiling and verifying monthly and end-of-year payment reports.
• Coordinate with scheduling and setup of study-related meetings.

Qualifications

MINIMUM QUALIFICATIONS:

Clinical Research Coordinator I:

• High school diploma or equivalent.
• Minimum one year experience in a clinical research or cancer registry environment with regulatory or human research protections.
• Demonstrated knowledge of how to synthesize study conduct.
• Ability to apply judgement in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.
• Excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment.
• Collaborative focus is essential, as well as strong written and verbal communication skills, including computer skills.

Clinical Research Coordinator II:

Minimum requirements for Clinical Research Coordinator I, plus:

• Minimum two to three years' experience in a clinical research or cancer registry environment with regulatory or human research protections.
• Knowledge of clinical trials records, procedures, and computerized data processing systems.
• Ability to work with multiple data management systems including generating reports and sourcing data from systems.
• Ability to extract data from medical records.

PREFERRED QUALIFICATIONS:

Clinical Research Coordinator I:

• Associate or Bachelor's degree preferred, particularly in biological, social or clinical science.
• Certified Clinical Research Coordinator (CCRC) or certification as Clinical Research Professional (SOCRA).
• Two years of experience in a research environment with regulatory or human research protections.
• Phlebotomy training
• Previous experience working with NIH, FDA and OHRP regulations and medical terminology.
• Knowledge of clinical trials records, procedures, and computerized data processing systems.
• Ability to understand and follow complex clinical research protocols at various sites.
• Strong working knowledge of Microsoft Outlook, Teams, Word and Excel.
• Willingness to maintain flexible working hours, including occasional work during early mornings and evenings

Clinical Research Coordinator II:

Preferred qualifications for Clinical Research Coordinator I, plus:

• Bachelor's degree in biological, social or clinical science preferred
• Bachelor's degree in another field with relevant experience in a clinical or laboratory setting will also be considered

Clinical Research Coordinator I

The hourly pay range for this position is from $26.48 to $37.70 and pay offered will be based on experience and qualifications.

Clinical Research Coordinator II

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).

Additional Information