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The University of Washington's Division of Allergy & Infectious Disease includes more than 50 faculty members located at the UW Medical Center, the Fred Hutchinson Cancer Research Center, the Seattle Cancer Care Alliance, and the VA Puget Sound Health Care System. Over the past 10 years, clinical and research programs in organ transplant infections have been in place to serve the needs of the regional organ transplant population and to participate in research aimed at improving the prevention, diagnosis, and treatment of infections in organ transplant recipients. The organ transplant infectious disease program is deeply committed to conducting research that aims to better understand and improve the care of infectious complications in transplant patients.
The Division of Allergy & Infectious Disease has an outstanding opportunity for a Research Coordinator in the Organ Transplant Infectious Disease Program. This individual will work with faculty in the Organ Transplant Infectious Disease Program to facilitate investigator-initiated and pharmaceutical-sponsored clinical trials, identify research problems and design hypotheses to be tested. This individual is responsible for independently designing and implementing multiple research projects to test hypotheses in human subjects.
A key mission of the Organ Transplant Infectious Disease Program is the conduct of clinical and translational research. At any given time, numerous clinical trials are actively recruiting at the within the transplant program. Under the direction of the Director of the Organ Transplant Infectious Disease Program, this individual will provide professional level support for clinical research studies involving human subjects.
This position requires operational knowledge of the University of Washington and Harborview Medical Center and requires in-depth understanding of the research process and ability to integrate this knowledge with research priorities to implement programmatic goals.
The position will: Participate in the design, conduct, analysis, and presentation of clinical research studies. Provide support to all aspects of clinical trials by completing Institutional Review Board applications, modifications, and annual status reports. Maintain adherence to research protocols and verify accuracy of research data. Continue excellent communication with sponsors, monitors, health care providers and outside agencies regarding ongoing research activities. Some complexities of this job are: a broad range of activities that require a diverse skill set, frequent short time frame deadlines, contact with patients with potentially transmissible infections and direct interactions with critically-ill patients. Full description of duties below.
Duties and Responsibilities:
Independently develop and implement research project procedures that 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).
Design, develop, document and maintain policies and procedures for patient registration and protocol 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 satisfies research objectives. Design, document and implement procedures for audits to assure protocol compliance and to ensure research data quality. Develop and implement corrective action plans to ensure protocol adherence and data integrity.
Develop and continually assess priorities to ensure that projects are executed successfully and completed within required time frames to meet research objectives.
Travel for protocol/study initiation meetings.
Coordinate clinical and research appointments, order tests and procedures to facilitate protocol adherence, billing compliance, and to ensure accurate and reliable data collection. Assist in monitoring patients and interacting closely with clinical providers to ensure patient safety and protocol adherence.
Communicate with outside physicians who are interested in referring patients to UWMC for clinical trials.
Develop 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.
Obtain patient specimens (e.g., blood, urine, stool, nasal swabs, etc.) and must have good hand-eye coordination and fine dexterity to aliquot patient specimens. Coordinate and oversee processing, inventory, and shipping of study specimens. Obtain research specimens from outside providers in compliance with institution and federal regulations.
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.
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 and general training (GCP, HIPAA, etc.).
Collaborate with internal and external partners. Maintain direct communication with faculty members, UW departments, funding sponsors, and research collaborators in support of the overall research plan.
Develop. manage and oversee lab safety protocols for the Research Lab including Standard Operating Procedures (SOPs) for specimen collection, processing (blood, urine, stool, saliva, respiratory samples), storage and/or shipping according to biohazard standards.
Ensure that all team members have been safely orientated to the lab, and have up to date training modules.
Direct training and supervision of Research assistants.
Develop clinical research protocols that clearly describe the research objectives and procedures necessary to test the hypotheses of the research project.
Write informed consent documents that meet institutional guidelines and satisfy Institutional Review Board requirements.
Work with multiple groups (e.g. UW Grant and Contract Services, UW Human Subjects Review Committee, Clinical Research Budgets & Billing, study sponsors) to ensure timely implementation of each research project
May direct the work of student helper, research assistant or research trainee.
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 Chemistry or equivalent plus at least one year experience in an academic research environment, preference will be given to candidate with prior research experience, knowledge of FDA and NIH requirements relating to research involving human subjects, knowledge of clinical trial development, implementation and analysis, excellent written and verbal communication skills, experience with Microsoft Office/Access/PowerPoint/Excel and Adobe Acrobat.
Able to work independently, self-starter, take on a leadership role whilst also being a team player; to maintain positive vision, sense of humor, and flexibility; to multi-task as priorities change, maintaining a professional demeanor at all times. Work ethic is incredibly important and prior experience in a work environment is preferred.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
2-3 years relevant experience
Prior experience with recruitment and facilitating research studies in a an academic environment
Competence with Excel, Word, PowerPoint, Access Database, and biostatistics.
Training in blood borne pathogens, shipping of hazardous materials,ncertification in Good Clinical Practice, Human subjects ethics training,nDMID source document and regulatory document training, HIPAA and other clinical research training.
Experience with EPIC/ORCA/MINDSCAPE/MAX/LIS record systems.
Related college coursework in immunology, physiology/anatomy, and microbiology.
Prior experience as a research assistant/coordinator, GCP training and/or Research Certification.
CONDITIONS OF EMPLOYMENT
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.
Founded in 1861, the University of Washington is one of the oldest public institutions in the west coast and one of the preeminent research universities in the world. The University of Washington is a multi-campus university comprised of three different campuses: Seattle, Tacoma, and Bothell. The Seattle campus is made up of sixteen schools and colleges that serve students ranging from an undergraduate level to a doctoral level. The university is home to world-class libraries, arts, music, drama, and sports, as well as the highest quality medical care in Washington State and a world-class academic medical center. The teaching and research of the University’s many professional schools provide undergraduate and graduate students the education necessary toward achieving an excellence that will serve the state, the region, and the nation. As part of a large and diverse community, the University of Washington serves more students than any other institution in the Northwest.