Clinical Research Coordinator I

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 Dvision at Fred Hutch is seeking a Clinical Research Coordinator to join their dynamic team of dedicated and skilled research staff working on clinical trials in the field of hematologic malignancies. The Clinical Research Coordinator will participate in the planning, coordination, and implementation of multiple industry- sponsored and investigator-initiated oncology clinical trials involving human subjects. In addition, this position will provide data coordination for one or more clinical trials supported by the team.

This role will have the opportunity to work partially at our campus and remotely.

This individual will work under the supervision of the Clinical Program Operations Manager and will be required to perform his/her responsibilities with a high level of independence within the scope of study protocol(s) and institutional guidelines.

Protocol Coordination - 70%
• Serve as designee of the Principal Investigator (PI) to manage the daily clinical operations of assigned research studies in accordance with regulatory, GCP guidelines and institutional policy.
• Review study candidates' medical records in detail for study eligibility.
• Ensure informed consent, initiate patient enrollment, and ensure accurate enrollment records are maintained.
• Educate clinical teams, ancillary departments, and patients to ensure safe and accurate protocol implementation.
• Develop and maintain tools for study implementation, which may include data collection tools, study reference materials, and study specific orders. Revise and utilize tools as necessary to fulfill the aims of the clinical trial.
• Monitor and track upcoming patient visits. Initiate scheduling of patient clinic visits, and on-going study visits. Attend patient visits and ensure clinical procedures, lab tests, and other protocol specific activities are completed as outlined in the protocols.
• Collaborate with Investigational Drug Services (IDS) and/or Nuclear Medicine on drug assignment, dispensation information, and maintain regular communication regarding status of study subjects.
• Ensure study drug self-administration and accountability with patients, perform non-clinical ECGs, administer study questionnaires and other protocol-driven non-clinical assessments.
• Function as a protocol liaison with clinical teams, patients, consortium partners, other institutions, and sponsors when necessary.
• Coordinate monitoring visits and respond to queries and other requests from study monitors.
• Data Coordination and Abstraction - 15%
  • Work independently to obtain, abstract, code and enter complex clinical information from multiple sources (medical records, research records, etc.) for research subjects into various study-specific electronic data-capture systems in according to contractual timelines.
  • Resolve and answer data queries with minimal errors.
  • Understand research study flow and work with other team members to perform the required research support tasks at appropriate study appointments.
  • For some research studies, independently request copies of radiology images, complete requisition forms and submit to pharmaceutical companies.
  • Develop study-specific data acquisition forms.
  • Work professionally with sponsor representatives to review and correct data recorded in the case report forms. Exercise independent judgment on query resolutions.
• Administrative - 15%
  • Collate and establish study-specific research and reference binders.
  • File requisitions and other research documentation in each patients' research chart.
  • Independently screen third party safety reports and submit to PI for review.
  • Complete and collect required regulatory documents for submission to pharmaceutical sponsors, internal review committees, and other regulatory authorities.
  • Assist with maintaining regulator folders in the electronic Binder system.
• Perform other duties as assigned.

MINIMUM QUALIFICATIONS

• 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 synthesis 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.

PREFERRED QUALIFICATIONS

• Bachelor's degree or equivalent experience.
• 2+ years of oncology clinical research or relevant/related experience
• CCRP or CCRC accreditation
• Previous experience in oncology research
• Prior exposure to CTMS, Florence, and/or EDC platforms
• A self-starter with the ability to locate resources and operate productively in an environment where standard operating procedures, guidelines and policies are not always available.
• Must have the flexibility to manage patients visits that may occur before or after regular work hours.
• Flexibility with work schedule required as required in-person work will be driven by research patient visits, which will be variable.

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 $26.48 to $37.70 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).