Clinical Research Coordinator I

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 looking for a Clinical Research Coordinator I to join our 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 clinical trials involving human subjects.

 

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

Responsibilities

This individual will work under the supervision of the Clinical Program Operations Manager and will be required to perform responsibilities with some independence within the scope of study protocols and institutional guidelines.

• 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.
• Initiate scheduling of patient clinic visits, and on-going study visits.  Attend patient visits and ensure clinical procedures, lab test, 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.
• Collaborate with Investigational Drug Services (IDS) 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, and when necessary, other institutions or drug companies. 
• Maintain appropriate source documentation, and complete or assist with accurate data entry into case report forms in a timely manner. 
• Coordinate monitoring visits and respond to queries and other requests from study monitors.
• Identify and report adverse events in accordance with protocol, regulatory guidelines, and institutional policy.
• Understand clinical trial budget and billing plans for patients enrolled on clinical trials.
• Collate and establish study-specific research and reference binders.
• File requisitions and other research documentation in patient's research charts.
• Provide back up for other Clinical Trial Coordinators as needed. Provide back up for Data Coordinator on applicable trials.
• Perform other duties as assigned.

Qualifications

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.
• Abil