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The purpose of this position is to promote the research objectives of the Cancer Vaccine Institute (CVI) in the Division of Medical Oncology. This position works directly with clinical and laboratory-based faculty members who specialize in translational immunotherapy research targeting a variety of cancers. This position will work as a member of the clinical research team that conducts primarily Phase I and Phase II Investigator-initiated clinical trials to test immune-based therapies for cancer.

Position Complexities

Complexities and dimensions of this position include the requirement for close collaboration with research partners in community oncology practices to identify potential study patients, to interview patients to assess interest in clinical trial participation, and to review medical records to determine if patients are eligible for immunotherapy trials. Patients currently being enrolled in CVI trials typically have advanced stage cancer, and the emotional impact of working closely with this patient population can be a challenge. In addition, the position ensures that research activities meet all institutional, sponsor, and federal requirements.

To implement investigator-initiated studies, this position will be well versed in all applicable Human Subjects Research regulations, HIPAA rules that protect patient privacy, and Good Clinical Practice guidance issued by the federal government. In addition, they will work closely with the CVI Immune Monitoring Lab, the UW CRBB, the UW Institute for Translational Health, the Fred Hutch Consortium IRB, and various UW clinical departments that provide research testing services.

This position requires the collection and organization of a large volume of detailed medical and clinical research information, and the ability to continually refine processes and procedures to work more efficiently and effectively. Continuous process improvements are routinely written as formal clinical Standard Operating Procedures.

Position Dimensions and Impact to the University

The UW Medicine CVI's mission is to conduct basic and clinical research that leads to the development of effective immune-based cancer therapies and diagnostic tests. The Research Coordinator will play a key role in implementing clinical trials that test new cancer therapies. They will work independently as a study recruitment leader, and as a member of a high functioning clinical research team. They will be knowledgeable and observant of all applicable rules, regulations, and guidelines for the safe and ethical conduct of clinical research.

RESPONSIBILITIES:

This position must be able to work independently on multiple research projects with minimal written policies or procedures.  This position requires daily interaction with pharmaceutical sponsors, physicians, other health care personnel (e.g. nurses, patient care coordinators, insurance companies), and patients. Up to 10 projects will be in progress simultaneously, with the expectation of additional projects in the future.

PROTOCOL MANAGEMENT – (40%)

Develop and implement research project procedure

•Ensure procedures meet research objectives and ensure compliance with all aspects of Institution, Federal Drug Administration (FDA) and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects (e.g. investigator financial disclosure requirements of the FDA).
•Develop, document, and maintain procedures for patient registration and protocol implementation to ensure that research execution meets Good Clinical Practice guidelines.
•Assist in the design, creation and revision of research instruments (e.g. case report forms, AE logs, Study guides) as necessary to ensure quality data that satisfies research objectives.
•Create and maintain complete source documentation for patients on assigned studies.

Assist with Regulatory Affairs

•Work with Regulatory Coordinator to ensure that reporting to the Institutional Review Board and study sponsors is timely, accurate and satisfies applicable regulation. Develop and implement corrective action plans to ensure protocol adherence and data integrity.
•Assist in preparing and conducting sponsor monitoring visits.

Other Protocol Management tasks

•Assist with minimal risk protocols, including consenting patients for sample collection.
•Assist with the maintenance of a manual for program-wide Standard Operating Procedures (SOPs) for clinical research.

PATIENT MANAGEMENT – (30%)

Implement research protocols

•Implement research protocols at UWMC and SCCA, integrating research and clinical requirements to ensure patient safety and protocol compliance.
•Communicate research requirements effectively with all providers involved in patient care.

Patient management and coordination

•Coordinate and assist with patients visits at the UW Medical Center with CVI clinical research staff.
•Manage complex patient schedules.
•Align research requirements and clinical care to ensure collection of accurate and reliable data.
•Assist in ensuring patient safety while participating on a clinical trial by monitoring patients and interacting closely with the patient's clinical providers.

Identifying eligible patients

•Independently obtain patient medical records, and develop a preliminary assessment of patient eligibility for Principal Investigator approval.
•Explain logistical, clinical, and scientific aspects of clinical trials to potential study participants by telephone, e-mail, and/or in written documents.
•Communicate with outside physicians who are interested in referring patients to UWMC/SCCA for clinical trials.

DATA MANAGEMENT – (30%)

•Retrieve data from patient charts and/or source documents, abstracts information from complex medical records and reports for entry into sponsor provided case report forms/database.  Case report form may be paper based or electronic.  CRF completion and data entry responsibility may be shared with other team members, necessitating accurate and timely communication with all team members.
•Prepare source data documents to collect/support all data associated with research protocols. 
•Work independently to obtain, abstract, and code complex clinical information from multiple sources (medical records, research records, etc.) for research subjects.  Code and record said information into various study-specific data-capture systems (both electronic and paper-based).
•Work professionally with sponsor representatives to review and resolve data and queries recorded in the case report forms. Exercise independent judgment on query resolutions.

OTHER

•Communicate with cancer patients effectively and with empathy
•Promote a proactive and professional relationship with internal and external staff and affiliates.
•Maintain strictest confidentiality.
•Actively participate in meetings and/or training as required.
•Serve as subject matter and protocol expert for assigned studies.
•Work with Manager and fellow team members to insure adequate staffing levels for Program, including helping to cover sick call, vacations, etc.
•Responsible for maintaining computer spreadsheets and databases for research studies.
•Understand research study flow, work with clinic staff, support services and research team as needed to implement clinical trials.

MINIMUM REQUIREMENTS:

•Bachelor's Degree in Life Sciences or health-related field or equivalent experience
•One year of experience in research setting or data analysis and entry

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


ADDITIONAL REQUIREMENTS:

•Excellent written and verbal communication skills
•Competency in Microsoft Office software
•Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to complete it within 90 days of hire

DESIRED

•Previous experience working with oncology patients
•Previous experience conducting research in a hospital or academic setting

WORKING CONDITIONS:

The Cancer Vaccine Institute is located at the UW Medicine at South Lake Union campus in a translational research environment that includes laboratory, clinical research and administrative office areas.

• Work week occasionally exceeds 40 hours.

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.