|Req #: ||145207 |
|Department: ||HEMATOLOGY |
|Job Location: || Health Sciences Center |
|Posting Date: ||05/19/2017 |
|Closing Info: || Open Until Filled |
|Salary: ||Salary is commensurate with experience and education |
| The University of Washington (UW) is proud to be one of the nation's premier educational and research institutions. Our people are the most important asset in our pursuit of achieving excellence in education, research and community service. Our staff not only enjoys outstanding benefits and professional growth opportunities, but also an environment noted for diversity, community involvement, intellectual excitement, artistic pursuits, and natural beauty. |
The University of Washington Division of Hematology is seeking an experienced Research Coordinator for clinical trials in patients with thrombocytopenia and bleeding disorders. This exciting position will collaborate in the design, organization and implementation of research protocols exploring the best treatments. The Research Coordinator will be involved in recruitment, enrollment, sample collection, completion of case report forms, organization and analysis of study data, completing Internal Review Board applications, ensuring compliance, and acting as a liaison to clinical staff and study sponsors on clinical trial activities.
Must be able to work independently 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.
Protocol Development and Management, and Regulatory
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.
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
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
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.
This position will work with clinical research involving human subjects within UW Medicine and therefore clinical Research Study Coordinator (RSC) training is required. The training requirement for this position includes UW Medicine- specific as well as general training.
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.
| Bachelor's Degree in nursing or a relevant field AND two years of experience OR equivalent education/experience. |
Current license to practice as an LPN or RN in the State of Washington.
Previous experience working with both inpatient and outpatient research setting.
Must have strong attention to detail.
Demonstrated effective written, verbal and interpersonal communication skills.
Demonstrated familiarity with computerized, analysis, records management, including demonstrated computer skills using MS Office and web based data management. Must be highly organized, able to multi-task and work independently, take initiative to start and complete projects.
There may be instances where individual positions must have additional licenses or certification. It is the employer's responsibility to ensure the appropriate licenses/certifications are obtained for each position.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
| Applicants should be highly motivated and energetic and while remaining personable, professional and organized under potentially stressful situations. |
Experience with regulatory paperwork and the Institutional Review Boards involved with research of human subjects; technical writing skills helpful.
Previous experience in clinical research project coordination; knowledge of FDA 21 CFR 50, and HHS 45 CFR 46 regulations, HIPAA, ICH Guidelines, and Good Clinical Practice; as well as, experience in clinical trial development, implementation, and analysis.
|CONDITION OF EMPLOYMENT:|
| Appointment to this position is contingent upon obtaining satisfactory results from a criminal background check. |
This position requires a flexible work schedule. 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.
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
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, Criminal Conviction History, 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.