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REGULATORY ASSISTANT (Fixed Duration/Temporary)
REGULATORY ASSISTANT (Fixed Duration/Temporary) |
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As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem-solving skills, and dedication to build stronger minds and a healthier world.
UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits, and natural beauty. The University of Washington Division of Hematology and Oncology has a Temporary position for a Regulatory Assistant to support the Hematological Malignancies Clinical Trials Research Program. The purpose of this position is to promote the research objectives of the Heme Malig Program in the Division of Hematology and Oncology. This position works with Division of Hematology and Oncology faculty and research staff to facilitate investigator-initiated and pharmaceutical-sponsored clinical trials. This position will work in conjunction with research staff implementing multiple research projects to test hypotheses in human subjects. The Regulatory Assistant will work to provide administrative and technical support to the research team to collect and maintain staff credentials. The Research Study Assistant will also provide administrative support to the Regulatory Coordinators to download and screen safety reports, assist with completion of regulatory documents, and help obtain signatures. At any one time upwards of 50 clinical trials may be active across the disease program. It is critical that this person be able to prioritize numerous concurrent tasks. This position also needs to manage both short term and long-term multi-step tasks. 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 integral to that mission. This position provides significant contributions to research development and implementation for the Division of Hematology and Oncology. It is responsible for assisting in the management of clinical trials, the majority of which provide significant financial support for the Division of Hematology and Oncology. Duties and Responsibilities This position must be able to work on multiple research projects without benefit of written policies or procedures. This position requires daily interaction with research staff, health care personnel (e.g. nurses, patient care coordinators, patient service representatives, medical assistants), pharmaceutical company sponsors and any other groups integral to the successful completion of the research project. Safety Data Coordination, Abstraction and Analysis • Work independently to abstract safety data from multiple sources (sponsor portals and reports, etc.) for research analysis by Regulatory Coordinators and Principal Investigators. • Make independent judgments about the relevance of the safety data to the research for complicated oncology research studies. • Principally responsible for monitoring and tracking upcoming pharmaceutical sponsor and government audits and maintaining research credentials. • Understand research study flow and work with research regulatory team members to perform the required research support tasks at appropriate study timepoints. Credential Coordination • Independently maintain and track current and former staff credentials and trainings. • Obtain laboratory credentials from external facilities. Administrative • Obtain faculty signatures both in-person and electronically. • Assist administrative staff with archiving of older documents. • Regulatory records management. • Perform related tasks as assigned. MINIMUM QUALIFICATIONS • Two years of college-level course work in a relevant academic area AND one year of appropriate experience or equivalent education/experience DESIRABLE QUALIFICATIONS • Bachelor's Degree in science-related field. • Demonstrated understanding of medical terminology. • Strong computer skills and experience with data entry and databases. • Strong attention to detail and ability to organize work. • Ability to communicate effectively both verbally and in writing, and to work effectively with colleagues, research subjects, and study sponsor representatives. • Demonstrated ability to work independently and to carry out complex tasks. • Knowledge of Oncology practice and terminology. • Prior working experience at the UWMC, FHCC, and/or SCCA. • Prior experience in basic processing laboratory samples. • Competency in Microsoft Office software. • Knowledge of HIPAA regulations. Working Environmental Conditions • This position is located in a clinical and research environment on the Fred Hutchinson Cancer Center campus. • Work hours may exceed 40 hours per week and can be deadline dependent. 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 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. |
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Committed to attracting and retaining a diverse staff, the University of Washington will honor your experiences, perspectives and unique identity. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable and welcoming. The University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran or disabled status, or genetic information. To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or dso@uw.edu. Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law. |
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