Cures Start Here. Fred Hutchinson Cancer Research Center (Fred Hutch), home of three Nobel laureates, is an independent, nonprofit research institution dedicated to the development and advancement of biomedical research to eliminate cancer and other potentially fatal diseases. Recognized internationally for its pioneering work in bone-marrow transplantation, Fred Hutch’s five scientific divisions collaborate to form a unique environment for conducting basic and applied science. The Fred Hutch, in collaboration with its clinical and research partners, the University of Washington and Seattle Children’s, is the only National Cancer Institute-designated comprehensive cancer center in the Pacific Northwest. Careers Start Here.

The Clinical Research Coordinator is responsible for day-to-day coordination of interventional, high-risk Phase I gene therapy clinical trials. S/he will participate in the planning, coordination, and implementation of complex investigator-initiated and cooperative group clinical research studies involving human subjects. This individual will work under the supervision of the Lead Clinical Research Coordinator/Research 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.

 
Responsibilities

• Serve as designee of the Principal Investigator (PI) to manage the daily clinical operations of clinical gene therapy studies in accordance with Good Clinical Practice guidelines, regulatory policies/guidelines, and institutional policies.
• Prepare study start-up templates and documentation including eligibility checklists, study-specific clinic orders, study calendars, data collection tools, and study reference materials. Revise and utilize tools as necessary.
• Review study candidates’ medical records for study eligibility, register enrolled patients, and ensure accrual enrollment records are maintained.
• Initiate scheduling of patient clinic visits and ensure that all 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. Coordinate research sample collections with research laboratory staff.
• 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.
• Work with internal partners to obtain and submit budget and billing information.

Other Duties that may be required

• Serve as project/study liaison, representing the project/study to other Center departments, funding sources, affiliated individuals or institutions, and outside organizations.
• Maintain or assist in maintaining IRB correspondence and study regulatory documentation. Prepare or assist in preparing annual renewals, protocol and informed consent form modifications, serious adverse event reports, and other study reports.
• Prepare or assist in preparing reports for Principal Investigator, Investigational New Drug Sponsor, FDA, IRB, NIH OSP, or industry sponsors.
• Participate in the review of charges for patients on clinical trials to ensure billing compliance.
• Other duties as assigned.

• BA/BS in related field required with a minimum of two to three years post-bachelor's work. Experience in clinical oncology research is preferred.
• Strong written and verbal communication skills, organizational skills, problem-solving and multi-tasking abilities are required. Collaborative focus is essential.
• Must have ability to work independently and take initiative in a dynamic environment. Must exhibit excellent dependability and ability to adapt and respond appropriately to competing priorities.