RESEARCH STUDY ASSISTANT-REGULATORY (FIXED DURATION/TEMPORARY)
University of Washington
- Seattle, WA
- $3,477-3,907 per month
- Temporary
- Part-time
Req #: 230583
Department: DEPARTMENT OF MEDICINE: HEMATOLOGY & ONCOLOGY
Appointing Department Web Address:
Job Location: Seattle - South Lake Union
Job Location Detail: Fred Hutchinson Cancer Research Center-South Lake Union
Posting Date: 02/06/2024
Closing Info: Open Until Filled
Salary: $3477 - $3907 per month
Other Compensation:
Union Position: Yes
Shift: First Shift
Benefits: As a UW employee, you will enjoy generous benefits and work/life programs. For a complete description of our benefits for this position, please visit our website,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 Phase 1 Program ( ) within the Department of Medicine's Division of Hematology and Oncology has an outstanding opportunity for a Temporary Clinical Research Assistant based at the Fred Hutchinson Cancer Center. Under the general direction and supervision of the Phase 1 Regulatory Manager, to promote the research objectives of the Phase 1 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 implementing multiple research and regulatory projects for the Phase 1 Oncology Clinical Trials Program. This position must be able to work on multiple projects, work efficiently, and support various staff at any given time.The Research Study Assistant will work provide administrative, technical, and regulatory support to the Phase 1 team to 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 many oncology patients across the disease program may be enrolled on clinical trials at any given time. 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.This position must be able to work on multiple research/regulatory projects without benefit of written policies or procedures. This position requires daily interaction with research staff, health care personnel, pharmaceutical company sponsors and any other groups integral to the successful completion of the research project.Specific ResponsibilitiesRegulatory coordination
Complete and collect required regulatory documents for submission to pharmaceutical sponsors, internal review committees, and other regulatory authorities.Assist with maintaining regulatory approval files.Assist with maintaining regulator folders in the eBinder system.Assist research staff with ongoing IRB and other regulatory submissions.Independently screen third party safety reports and submit to PI for review.Assist with consent form modifications as directed by a coordinator.Assist with processing of incoming MedWatch/IND safety reports.Delivery and transmittal of important/urgent documents to IRB and other institutional committees.Data Coordination and AbstractionWork independently to obtain, abstract, code and enter complex clinical information from multiple sources (medical records, research records, etc.) for research subjects into various study-specific electronic data-capture systems.Resolve and answer data queries with minimal errors.Gathering data for various reports i.e. Continuing Review.Complete data entry and document management in OnCore Clinical Trial Management System (CTMS).Make independent judgments about the relevance of the clinical data to the research.Work with Research Coordinators to develop study-specific data acquisition forms.Protocol Coordination
Independently maintain and track laboratory sample supplies, complete requisition forms, and assemble kits for upcoming research subject visits for assigned clinical trials.Obtain medical records from external providers and facilities. Assist with compilation of medical chart documents and scanning/filing.For some research studies, independently request copies of study images, complete requisition forms and submit for process.Administrative
Assist with general files organization and archiving, recording and routing documents and reports for signatures.Collate and establish study-specific research and reference binders.Manage, sort, and distribute incoming/outgoing mail and faxes. Follow study specific guidelines for collection, labeling, and/or shipping of research samples.Schedule and document meetings.Check voicemails and route messages appropriately.Handle Outlook shared accounts email correspondence.Perform related tasks as assigned; Other projects and duties as needed.Minimum Requirements:
- Two years of college-level course work in a relevant academic area AND one year of appropriate experience or equivalent education/experience.
- Excellent oral and written communication skills.
- Outstanding attention to detail and problem-solving skills.
- Ability to work independently and prioritize tasks.
- Maintain a high degree of confidentiality and professionalism.
- Excellent Microsoft Outlook, Word, and Excel skills.
- Tech-savvy and can learn new web-based systems and software.
- Must be a fast learner, enthusiastic, and motivated.
- Knowledge of Oncology practice and terminology
- Prior working experience at the UWMC and FHCC
- Prior experience in basic processing laboratory samples
- Competency in Microsoft Office software.
- Knowledge of HIPAA regulations