Salary is commensurate with experience and education
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 Oncology has an outstanding opportunity for a full-time Clinical Trials Specialist. This position is responsible for clinical trial study start up processes in the Head and Neck (H & N) Medical Oncology program in the Division of Medical Oncology. This position will accelerate clinical trial study start up by developing and optimizing new and ongoing study start-up processes. This position will coordinate the submission of a wide range of study start-up documents including pricing requests to various UW, SCCA, and FHCRC departments, developing study budgets, and staying current with numerous University, sponsor, and FDA policies, guidelines, and related procedures.
This position is required to use independent judgment, leadership and knowledge of the academic clinical trial business to effectively facilitate the work flow and promoting a collaborative work environment. The position will maintain dynamic communication with the study investigators, research staff, numerous University departments, SCCA departments, and the FHCRC departments, other development partners (other universities, federal, and industry partners). This position is supervised by and reports to the H & N Oncology Research Manager.
This position is constantly required to integrate information from multiple sources to ensure that all study start-up proposals meet the requirements of the University and external agencies, institutions and industry. This position is required to coordinate efforts and provide information across the Alliance partners including UWMC, FHCRC, SCCA, and Harborview departments and staff.
This position is key to the success of the H & N Oncology Clinical Research Program and promotes timely study start-up oncology clinical trials. It will require a strong partnership with faculty and staff within and external to the programs.
Manage clinical trial start-up processes
Establish and maintain methods to initiate study start-up budget planning.
Use knowledge of clinical research, medical terminology, and clinical processes to interpret complex oncology protocol requirements, identify protocol requirements that will impact clinical trial budgets and facilitate submissions to relevant compliance offices.
Working with the Research Manager and faculty, establish methods to translate study start-up pricing and budget efforts into study tracking tools, to streamline the invoicing of sponsors based on patient accrual and visits.
Forecast, track and report study start-up timelines.
Develop and track study start-up pieces and report progress to Research Managers, faculty, and study team members.
Produce monthly and quarterly study start-up metric reports using established formats.
Independently develop and implement research project procedures and tools that meet research objectives and ensure compliance with all aspects of Institution, 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). Communicate research requirements effectively with all providers involved in patient care.
Design, develop, document and maintain policies and procedures for protocol 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 satisfies research objectives. Design, document and implement procedures for audits to assure protocol compliance and to ensure research data quality. Develop and implement corrective action plans to ensure protocol adherence and data integrity. Perform other duties as assigned.
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.
Bachelor's Degree in Business, science or related field plus a minimum of two years experience with clinical research budget development, clinical research coordination, or related research or healthcare experience
Ability to work effectively and efficiently in a group environment
Exceptional organizational and customer service skills
Strong written and oral presentation skills
Ability to communicate effectively with all levels of faculty, management and clinical research staff
Ability to convey complex policy, financial and scientific/technical information in a manner that is understandable to a wide audience
Ability to teach and mentor others in group settings, in one-on-one sessions, and remotely
Ability to prioritize and organize work independently
Demonstrated skill in using Microsoft Excel
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
Experience in an academic medical center
Experience as a research study coordinator
Experience in oncology clinical research
Familiarity with interpreting regulatory and contractual documents, identifying and resolving ambiguities, negotiating pricing and payment terms, and interpreting complex implications of research protocols
Knowledge of the Medicare Clinical Trials Policy and other federal, state and institutional clinical research regulations
Experience with using International Classification of Diseases, 9th Revision (ICD-9), Current Procedural Terminology (CPT), and Healthcare Common Procedure Coding System (HCPCS) billing codes in a clinical research environment
Strong working knowledge of Microsoft Office Suite
CONDITIONS OF EMPLOYMENT
Appointment to this position is contingent upon obtaining satisfactory results from a criminal background check.
Fast-paced office environment, with a high volume of often-complex projects. The work is deadline driven and requires rapid and frequent communications, not only between individuals, but also by computer and/or telephone for much of the day. Projects may require travel between affiliate locations to facilitate budgeting communication.
The position is located in a clinical and research environment that is located at the Seattle Cancer Care Alliance on the Fred Hutchison Cancer Research Center campus.
This position requires a flexible work schedule. Stringent deadlines from sponsor organizations/companies to meet deadlines may require overtime including occasional evening and weekend overtime.
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 Workforce Authorization, Criminal Conviction History, 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.
Founded in 1861, the University of Washington is one of the oldest public institutions in the west coast and one of the preeminent research universities in the world. The University of Washington is a multi-campus university comprised of three different campuses: Seattle, Tacoma, and Bothell. The Seattle campus is made up of sixteen schools and colleges that serve students ranging from an undergra...duate level to a doctoral level. The university is home to world-class libraries, arts, music, drama, and sports, as well as the highest quality medical care in Washington State and a world-class academic medical center. The teaching and research of the University’s many professional schools provide undergraduate and graduate students the education necessary toward achieving an excellence that will serve the state, the region, and the nation. As part of a large and diverse community, the University of Washington serves more students than any other institution in the Northwest.