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The Division of Nephrology has an outstanding opportunity for a Research Coordinator in the Kidney Transplant Program. Under the direction of the Medical Director of the Kidney Transplant Program, this individual will work with faculty in the Kidney Transplant Program to facilitate investigator-initiated and pharmaceutical-sponsored clinical trials.
This position requires operational knowledge of the University of Washington and requires in-depth understanding of the research process and an ability to integrate this knowledge with research priorities to implement programmatic goals.
Specific responsibilities include the following:
Independently develop and implement research project procedures per the requirements outlined in sponsored research protocols. Procedures should 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.
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 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,
Bachelor's degree in sciences, public health, or related discipline and two to three years of experience in an academic research environment or equivalent combination of education and experience.
Able to work independently and be a team player; to maintain positive vision, sense of humor, and flexibility; to multi-task as priorities change; and to maintain a professional demeanor at all times.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
Prior experience working with transplant patient population, 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 and Adobe Acrobat.
Prior experience with recruitment and facilitating studies in immunocompromised transplant patients in solid organ transplant patients.
Competence with Excel, Word, Powerpoint, Access Database, and biostatistics.
Training in blood borne pathogens, shipping of hazardous materials, certification in Good Clinical Practice, Human subjects ethics training, DMID source document and regulatory document training, HIPAA and other clinical research training.
Experience with EPIC/ORCA/MINDSCAPE/MAX record systems.
Related college coursework in immunology, physiology/anatomy, and microbiology.
Prior experience as a research coordinator, GCP training and/or Research Certification.
CONDITIONS OF EMPLOYMENT
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.