Research Coordinator ; NE S UAW Research

Position: Research Coordinator 2 (NE S UAW Research)
** Job Description
**** The Division of Hematology & Oncology has an outstanding opportunity for a full-time Research Coordinator 2.
** The purpose of this position is to promote the research objectives of the UW Hematology Clinical Research Program, which includes Acute Leukemia, Myeloid Neoplasms, and Classical Hematology disease indications. This position works with faculty, staff, and departments across multiple institutions to implement and coordinate multiple investigator-initiated and pharmaceutical-sponsored clinical trials.

The University of Washington's Division of Hematology & Oncology includes 130+ faculty members located at the UW Medical Center, the Fred Hutchinson Cancer Center, and the VA Puget Sound Health Care System. Over the past 40 years, members of the Division have developed the world's leading bone marrow transplant program. In addition, members of the Division have made substantial contributions to many other areas of cancer treatment, including the use of tumor vaccines, cellular therapy for cancer, antibody-based treatments, and novel forms of chemotherapy and hormonal therapy.

Our division is deeply committed to maintaining its position as one of the leading centers for research and treatment of cancer in the world.
** DUTIES AND RESPONSIBILITIES
***** Protocol, Patient, and Data Management - 75%
**** 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.
* Design, develop, document and maintain policies and procedures for protocol registration and implementation to ensure research execution meets good clinical proactive guidelines.
* Design, create, revise, and complete research instruments (e.g. case report forms, protocol visit checklists, subject trackers) as necessary to ensure quality data that correlates with research objectives.
* Ensure that projects are executed successfully and completed within needed time frames to meet research objectives.
* Prepare laboratory and specimen collection kits according to protocol and lab manual instructions. Work with different departments across UW and FHCC to collect, process, and transport specimen samples.
* May process labs for clinical trials, including centrifuging and aliquoting specimens, and ship specimens in accordance with federal and institutional biologics shipping regulations.
* Ensure protocol compliance by managing patient appointments, including proposing research specific orders within the EMR, and coordinating with patient's clinical providers (e.g. physicians, physician assistants, and nurses) to collect reliable and accurate data.
* Advise clinical staff which tests and procedures are needed during each research visit to facilitate protocol adherence, billing compliance, and to ensure accurate and reliable data collection. Work closely with clinical providers to ensure that study therapy is administered in accordance with the clinical protocol (e.g. dose modifications are implemented when required by the protocol).
* Support and ensure complete protocol compliance and data collection in clinic. This includes collection of adverse events, concomitant medications, administering quality of life questionnaires, or other procedures required by protocol.
* Ensure patient safety while participating in clinical trials by monitoring patients and interacting closely with patients' clinical providers and care team.
* Timely and appropriate reporting of Adverse Events and Serious Adverse Events to sponsors and review boards to ensure compliance to protocol and FDA requirements.
* Understand 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 fiscal staff when financial milestones have been met.
* Record and track patient protocol visits and assessments, including procedures in the Clinical Trial Management System.
* Work with the Regulatory Coordinator to ensure that reports to the Institutional Review Board, FDA, and/or study sponsors are timely, accurate, and satisfy applicable regulations. With minimal guidance, develop and implement corrective action plans to ensure protocol adherence and data integrity.
* Assist with implementing procedures for protocol audits to assure protocol compliance and research data quality.
* Take action to correct problems such as deviations from protocol requirements to ensure research quality. Assist with creating and implementing CAPA plans.
* May initiate and maintain communication with outside physicians who refer patients to UWMC and/or FHCC for clinical trials.
* Work independently and with study team members to obtain, abstract, and code…