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The purpose of this position is to promote the research objectives of the Division of Hematology. This position works with Division of Hematology faculty to facilitate investigator-initiated and industry-sponsored clinical trials.

This position is constantly required to integrate information from multiple sources to ensure that all research proposals meet the requirements of the University, the Food and Drug Administration, the National Institutes of Health and the study sponsor. This position develops procedures that ensure that all research meets or exceeds these requirements while expeditiously furthering the research objectives of the Division of Hematology. There are multiple resources available within the University system (e.g. Grant and Contract Services, Institutional Review Board, Office of Industry Relations) to help in this process, but ultimately, the work must be done independently and in a resourceful manner to expedite the Division’s research objectives. This position is also responsible for organizing and facilitating sponsor-initiated, FDA-initiated, and institution-initiated audits of study data. Finally, this position interacts with representatives from federal and state agencies, foundations, pharmaceutical companies, health care providers and cancer patients in a manner that well-represents the University of Washington and its associated institutions (FHCRC and SCCA).

The mission statement of the University of Washington Medical Center states that the Medical Center serves as a research resource, providing an environment in which clinical research may be conducted. This position is essential to that mission. This position provides significant contributions to research development, implementation and analysis for the Division of Hematology. It is responsible for overseeing the management of clinical trials.

This position must be able to work independently under administrative direction on multiple research projects; at times, without the benefit of written policies or procedures, while concurrently helping to create best practices moving forward. This position requires daily interaction with sponsors, physicians, the U.S. Food and Drug Administration, other health care personnel (e.g. nurses, patient care coordinators, insurance companies), and patients. Up to 15 projects will be in progress simultaneously, with the expectation of additional projects in the future.

DUTIES AND RESPONSIBILITIES
Protocol Development and Management, and Regulatory - 45%

Write informed consent documents that clearly describe the nature and risks of the research project in language that is easily understandable to the individual patient.

Timely and appropriate reporting of Adverse Events and Serious Adverse Events to sponsors and review boards to ensure compliance to protocol and FDA requirements.

Work with multiple UW, SCCA, and Fred Hutchinson Cancer Research Center (FHCRC) groups (e.g. UW Grant and Contract Services, UW Human Subjects Review Committee, UW and SCCA Radiation Safety Committee, UW and FHCRC Biosafety Committee, SCCA Research Implementation Office, and UWMC General Clinical Research Center) to ensure timely implementation of each research project.

Protocol Management – Independently develop and implement research project policies and procedures that meet research objectives and that ensure compliance with all aspects of 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).

Design, develop, document and maintain policies and procedures for protocol registration and implementation to ensure that research execution meets good clinical practice guidelines.

Design, create and revise research instruments (e.g. case report forms) as necessary to ensure quality data that correlates with research objectives.

Design, document and implement procedures for protocol audits to assure protocol compliance and to ensure research data quality.

Study Subject Management - 40%

Take action to correct problems such as deviation from protocol requirements to ensure research quality.

Ensure that projects are executed successfully and completed within needed time frames to meet research objectives.

Process labs for clinical trials, including collecting, centrifuging and aliquoting specimens, and ship specimens in accordance with federal and institutional biologics shipping regulations.

Patient Management - Ensure protocol compliance by managing patient appointments and coordinating with patient’s clinical providers (e.g. physicians, physician assistants, and nurses) to collect reliable and accurate data.

Ensure patient safety while participating in clinical trials by monitoring patients and interacting closely with patient’s clinical providers.

Initiate and maintain communication with outside physicians who refer patients to UWMC for Hematologic clinical trials.

Analysis and Reporting – 15%

Analysis and Reporting – Prepare interim reports for principal investigators, industry sponsors and Institutional Review Board to ensure that each project is moving toward timely completion.

Prompt completion of electronic data capture systems and electronic case report forms. Timely resolution of queries and questions from industry sponsors, contract research organizations, institutional groups and our affiliates.

Other duties as assigned.

MINIMUM REQUIREMENTS

Bachelor's Degree in Biology or health related field AND two years of relevant work experience

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

ADDITIONAL REQUIREMENTS

Knowledge of HIPAA regulations.

Knowledge of FDA and GCP (Good Clinical Practice).

Strong attention to detail and ability to multi-task, organize and prioritize projects.

Experience working in inpatient/outpatient research setting.

Excellent written and verbal communication skills, experience with Microsoft Office.

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 30 days of hire.

DESIRED QUALIFICATIONS

Previous experience working with Hematology patients.

CCRC or CCRP endorsement

Application Process:
The application process 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.