Commensurate with education/ex
The University of Washington (UW) is proud to be one of the nation’s premier educational and research institutions. Our people are the most important asset in our pursuit of achieving excellence in education, research, and community service. Our staff not only enjoys outstanding benefits and professional growth opportunities, but also an environment noted for diversity, community involvement, intellectual excitement, artistic pursuits, and natural beauty.
The University of Washington's Division of Medical Oncology's includes 41 faculty members located at the UW Medical Center, the Fred Hutchinson Cancer Research Center, the Seattle Cancer Care Alliance, and the VA Puget Sound Health Care System. Over the past 25 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.
The Division of Medical Oncology has an outstanding opportunity for a full-time Research Coordinator. This position will provide research coordination and clinical trials management to the Sarcoma Research Program. At any given time, there will be approximately 20 active clinical research trials and anywhere from 5 to 10 trials in the process of being activated. This position will oversee all aspects of study coordination, including assisting with informed consent, order placement, protocol compliance, patient visits, and billing compliance. This position will be responsible for management of multiple comprehensive trials, and mentorship of junior staff. In addition, this position will have knowledge of and represent the assigned clinical trials to the three Cancer Consortium partner institutions: the Seattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center, and the University of Washington. This position will include management of phases I-IV industry, investigator-led, and NIH sponsored research studies.
This position is required to use independent judgement, leadership, and knowledge of the academic clinical trial operations processes to effectively facilitate work flow, and promote a collaborative work environment. This position will maintain dynamic communication with study investigators, research staff, numerous University departments, clinical trial participants, SCCA departments, FHCRC departments, federal agencies, and industry partners. This position may be responsible for independently designing and implementing multiple research projects to test the hypotheses in human subjects and facilitate laboratory correlative work.
This position is supervised by and reports to the Research Manager for the Sarcoma Program.
This position will work with minimal supervision in performing assignments, and will work closely with the Research Manager, Research Coordinators, Regulatory Coordinators, and Fiscal Analysts in making decisions within University Guidelines, and ensuring that all work is carried out in a timely and efficient manner.
This position is constantly required to integrate information from multiple sources to ensure that all clinical trials are maintaining appropriate conduct, and meet the requirements of the University, the Food and Drug Administration, the National Institutes of Health and the study sponsor.
This position requires independent decision making on all aspects of clinical trial management. This position is required to coordinate efforts across the Alliance partners, including UWMC, FHCRC, SCCA, and Harborview, as needed.
This position will have consistent contact and interactions with clinical trial participants. This position interacts with representatives from pharmaceutical companies, health care providers, and terminally ill patients in a manner that well-represents the University of Washington and its associated institutions.
This position is also responsible for, in collaboration with the Research Manager, organizing and facilitating sponsor-initiated, FDA-initiated, and institution-initiated audits of study data
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 essential to that mission. This position provides significant contributions to research development, implementation and analysis for the Sarcoma Program in the Division of Oncology. It is responsible for overseeing the management of up to 15 clinical trials, the majority of which provide significant financial support for the Division of Oncology.
This position must be able to work independently under administrative direction on multiple research projects without benefit of written policies or procedures. This position requires daily interaction with pharmaceutical 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 15 projects will be in progress simultaneously, with the expectation of additional projects in the future.
Research Patient Management
Communicate with external patients or external physicians who are interested in referring patients to UWMC/SCCA for Sarcoma oncology clinical trials. Work with internal and external physicians to screen patients and identify therapeutic pathways that optimize patient's clinical trial participation opportunities. Communicate with sponsors to get approval to enroll patients.
Manage complex study appointments, ordering tests and procedures to facilitate protocol adherence, billing compliance, and to ensure accurate and reliable data collection. Participate in consenting of patients with providers. Escort patients to study appointments. Educate patients about the trial requirements and visit schedule. Conduct interviews with patients to collect research data per protocol. Assist in monitoring patient toxicities and interacting closely with clinical providers to ensure patient safety and protocol adherence. Communicating protocol requirement for treatment modifications to providers.
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 research staff when financial milestones have been met.
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 (e.g. investigator financial disclosure requirements of the FDA).
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, complete 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.
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.
Process labs for clinical trials, including collecting, centrifuging and aliquoting specimens, and ship specimens in accordance with federal and institutional biologic shipping regulations.
Assist in developing clinical research protocols that clearly describe the research objectives and procedures necessary to test the hypotheses of the research project. Work with multiple UW, SCCA, and Fred Hutchinson Cancer Research Center (FHCRC) groups (e.g. UW Grant and Contract Services, UW Human Subjects Review Committee, UW and SCCA Radiation Safety Committee, UW and FHCRC Bio safety Committee, SCCA Clinical Trials Planning Committee and UWMC General Clinical Research Center) to ensure timely implementation of each research project.
Manage complex clinical research protocols successfully and meet all regulatory and compliance guidelines.
Develop key research collaborations with internal and external partners.
Maintain direct communication with faculty members within and external to the Division of Oncology, UW departments, funding sponsors and research collaborators in support of individual studies and the entire research program.
Involve physician leadership as appropriate to identify and ameliorate bottlenecks with clinical trial implementation. Use problem solving and interpersonal skills to assist with organized process improvement efforts.
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.
Other Projects As Assigned
Although not responsible for the supervision of staff, this position is expected to mentor less experienced staff within Sarcoma Program as directed by Sarcoma management.
Bachelor’s Degree in Life science, health related, or relevant field.
A minimum of 2 years experience in clinical research project coordination and/or clinical trials management
Knowledge of FDA and NIH requirements
Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to complete it within 30 days of hire.
Oncology clinical trial coordination experience.
Knowledge of University of Washington/Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance processes.
CONDITIONS OF EMPLOYMENT:
The ability to multi-task and be flexible while maintaining a professional demeanor is crucial as priorities change throughout each day. May have to respond to multiple requests for information (e-mail, voicemail, ****-543-6452 (tty) or ****