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The Department of Hematology is seeking a full time Clinical Data/Research Coordinator.

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

This position is responsible for implementing multiple research projects to test the hypotheses in human subjects.  This position requires the ability 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.  With guidance, 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.

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. 

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.

RESPONSIBILITIES:

Protocol Management

•  With minimal guidance, implement research project procedures that meet research objectives and ensure compliance with all aspects of the institution, the Food and Drug Administration (FDA), and the 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.
•  Work with clinical research staff to design, create, and revise research instruments (e.g. case report forms) as necessary to ensure quality data that satisfies research objectives.
•  Prompt completion of electronic data capture systems and electronic case report forms. Timely resolution of queries and questions from industry sponsors, contract research organizations, and Institutional Review Boards.
•  Work with Regulatory Coordinator to ensure that reports to the Institutional Review Board and study sponsors are timely, accurate, and satisfy applicable regulation. With minimal guidance, develop and implement corrective action plans to ensure protocol adherence and data integrity.
•  Work collaboratively with research team to ensure that projects are executed successfully and completed within required time frames to meet research objectives.

Patient Management

•  Advise clinical staff which tests and procedures are needed during each research visit to facilitate protocol adherence, billing compliance, and to ensure accurate and reliable data collection. Work closely with clinical providers to ensure that study therapy is administered in accordance with the clinical protocol (e.g. dose modifications are implemented when required by the protocol).
•  Communicate with outside physicians who are interested in referring patients to UWMC/SCCA for Hematology clinical trials.
•  Prepare laboratory and specimen collection kits for data collection purposes. Work with different departments across SCCA, UW, and FHCRC to collect, process, and transport specimen samples.
•  Understand clinical trial budget and billing plan for patients enrolled on clinical trials.
•  Work with internal partners to ensure clinical trials are performed in accordance with institutional requirements for billing compliance.  Assist in financial audits as necessary.
•  Communicate with investigators and research staff when financial milestones have been met.

Analysis and Reporting

•  Prepare interim reports for principal investigators, industry sponsors, and Institutional Review Boards to ensure that each project is moving toward timely completion.
•  This position will work with clinical research involving human subjects within UW Medicine and therefore Clinical Research Coordinator (CRC) training is required.  The training requirement for this position include UW Medicine-specific, SCCA-specific, Fred Hutch-specific, and general training.

MINIMUM REQUIREMENTS:

•  Bachelor's degree in related field
•  Experience can substitute for degree
•  Minimum of 1 year experience working in human subjects research, experience in research implementation or data analysis and entry, 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 90 days of hire.
•  Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.

DESIRED EXPERIENCE:

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

WORK ENVIRONMENT:

• This position requires a flexible work schedule.  Stringent deadlines from sponsors and faculty for protocol implementation and data collection may require overtime.  Integrating required elements of research into complex patient schedules (e.g collecting and processing multiple blood specimens for pharmacokinetic sampling) may also require occasional overtime.
• Sitting at desk for majority of working hours; working on a computer and on the telephone in a cubicle in a public area with little privacy.  Ability to multi-task and be flexible while maintaining a professional demeanor is crucial as priorities change throughout each day. May respond to multiple requests for information (e-mail, voicemail, fax, verbal), determining priorities.
• This position is located in a clinical and research environment that is located at the Seattle Cancer Care Alliance on the Fred Hutchinson Cancer Research Center campus and requires the ability to walk between offices, clinic, and other facilities, up to 1 mile.
• Must be available to enroll patients and maintain email/pager contact with 24/7 availability.  Some evening and weekend travel to study meetings and sites may be required.  

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 Workforce 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.