Research Coordinator

** Job Description
** 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 Division of Hematology & Oncology has an outstanding opportunity for a full-time
** Research Coordinator**. 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.
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* Position Responsibilities:

** This position must be able to work with limited supervision on multiple research projects; at times, without the benefit of written policies or procedures, while concurrently helping to create best practices moving forward. This position requires daily interaction with sponsors, physicians, the U.S. Food and Drug Administration, other health care personnel (e.g. nurses, patient care coordinators, insurance companies), and patients.

Up to 10 projects will be in progress simultaneously, with the expectation of additional projects in the future.

Protocol Management, and Regulatory - 50%
* Implement research project procedures that meet research objectives and ensure compliance with all aspects of Institution, Food and 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).
* Use knowledge of clinical research, medical terminology, and clinical processes to interpret standard protocol requirements and identify protocol procedures that will impact clinic operations.
* Design, develop, document, and maintain policies and procedures for protocol registration and 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 correlates with research objectives.
* Design, document, and implement procedures for protocol audits to assure protocol compliance and to ensure research data quality.
* Work with research team to ensure that projects are executed successfully and completed within required time frames to meet research objectives.
* Prompt completion of electronic data capture systems and electronic case report forms. Timely resolution of queries and questions from industry sponsors, contract research organizations, and Institutional Review Board.
* Work with Regulatory Coordinator to ensure that reports to the Institutional Review Board and study sponsors are timely, accurate, and satisfy applicable regulation. Work with research team on developing and implementing corrective action plans to ensure protocol adherence and data integrity.
* 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.
* Communicate with investigators and research staff when financial milestones have been met.

Study Subject Management – 40%
* 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).
* Take action to correct problems such as deviation from protocol requirements to ensure research quality.
* Ensure that projects are executed successfully and completed within needed time frames to meet research objectives.
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