RESEARCH COORDINATOR, RADIATION ONCOLOGY: CLINICAL TRIALS

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The Department of Radiation Oncology, within School of Medicine, has an outstanding full-time opportunity for a Research Coordinator to join our team. This position will provide professional-level support for clinical research studies open in Radiation Oncology and serve as point of contact for clinical trial regulatory and compliance. The coordinator will maintain all regulatory documents for all trials and provide compliance and regulatory expertise to faculty PI and their research team. This position will work closely with the Cancer Consortium clinical research support and Clinical Trial Office to ensure regulatory and compliance requirements are met for Radiation Oncology clinical research trials.

The Department of Radiation Oncology is an integral part of the Cancer Program at the University of Washington and a major contributor to the contribution margin of each of the seven centers at which we provide professional services: University of Washington Medical Center (UWMC); the Gamma Knife facility at Harborview Medical Center (HMC); the Fred Hutch Cancer Care (FHCC); the Radiation Oncology Suite on the Northwest Hospital Campus (FHCC@NWH); the FHCC Proton Therapy Center (PTC); Seattle Children’s Hospital (SCH);  Seattle Puget Sound VA Medical Center; and most recently, the SCCA Peninsula .  We have 29 physician faculty, 28 science PhD faculty, 12 ARNP faculty, 11 radiation oncology residents, 4 medical physics residents, and 2 fellowship faculty on staff with additional postdoctoral fellows and graduate students participating in various research projects in radiation biology and molecular medicine, medical physics, and radiation chemistry.

The UW School of Medicine is a large school within the UW and a critical partner in delivering care through UW Medicine.  Radiation Oncology, within the school, is the only local provider of proton and neutron therapy for tumors, in addition to the more traditional photon treatments. This has a significant impact on UW’s national reputation.  Radiation Oncology will be a key clinical and research partner with Fred Hutch Cancer Center and Radiation Oncology’s success with make a significant impact on the success of this new partnership between UW and FHCC. This position is essential to support the department research mission. 

RESPONSIBILITIES:

•  Support, coordinate, and implement all regulatory submissions to internal and external governing bodies. These include but are not limited to the Institutional Review Board, the Institutional Biosafety Committee, the Institutional Radiation Safety Committee, and the Scientific Review Committee. This includes new study applications, annual reviews, and modifications to existing studies, serious adverse events, and protocol deviations.

• Maintain and update all required regulatory documents (FDA Form 1572 and/or 1571, protocol signature page, Investigator's Brochure, financial disclosures, laboratory accreditations, laboratory reference ranges, CVs, medical licensures, delegation of authority logs, and related forms per sponsor or federal requirements).

•  Write clinical research trial consent forms in accordance with GCP and FDA guidelines, ensuring all appropriate elements of informed consent.

•  Assist in writing Investigational New Drug applications and annual reports for investigator-initiated clinical trials. Coordinate initial, ongoing submissions and annual reports to the FDA.
•  Translate complicated research protocol requirements into language easily understandable by research participants and laypersons.

•  Maintain knowledge and understanding of all active UW Radiation Oncology clinical trials to ensure regulatory compliance.

•   Work with the Clinical Research Manager to create and maintain applicable Standard Operating Procedures (SOPs)/guidelines, as well as ensure compliance with the SOPs/guidelines. This position may also perform Quality Assurance checks on regulatory files as needed and implement/maintain relevant training of research staff and collaborators. This position will also implement and maintain standardization of research records in both electronic and hard copy format in order to simplify cross coverage and ensure optimal research compliance and communication.

•  Work with the Clinical Research Manager on the development of SOPs/guidelines and identify/maintain training requirements of the research team and collaborators. Implement/maintain standardization and organization of research records and communication in electronic and hard copy format to ensure optimal research compliance and communication within and outside of the research team.

•  Assist in study start up activities.

•  Assist in the development of protocols for therapeutic clinical trials as well as minimal risk translational research projects and chart review projects.

•  Perform related tasks as assigned.

MINIMUM REQUIREMENTS:

Bachelor's Degree in Biology or other related science/medical or Health Information Management AND two years experience in program management of a research project OR equivalent education and experience.

ADDITIONAL REQUIREMENTS:

Must have worked in previous positions that require excellent organizational and communication skills in medical or related field and have some knowledge of regulatory requirements as it applies to research.

Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.

DESIRED EXPERIENCE:

Certification in SoCRA, ACRP.  Previous work in research study coordination or experience working in an IRB or experience with working in CRBB. 

Application Process:

The application process for UW positions may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process.  These assessments may include Work Authorization, Cover Letter and/or others.  Any assessments that you need to complete will appear on your screen as soon as you select “Apply to this position”. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment you will be prompted to do so the next time you access your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.