What are the responsibilities and job description for the CLINICAL TRIALS SPECIALIST position at University of Washington (UW) Medicine?
Req #: 242135 Department: DEPARTMENT OF MEDICINE: HEMATOLOGY & ONCOLOGY Appointing Department Web Address: https://hemonc.uw.edu/ Job Location: Seattle - Other, Seattle - South Lake Union Job Location Detail: This job is located at the Fred Hutchinson Cancer Center campus. Posting Date: 12/31/2024 Closing Info: Open Until Filled Salary: $5,417 - $7,084 per month Other Compensation: 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, click here.
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 Thoracic, Head & Neck and Neuro Oncology Research Program, in the Division of Hematology and Oncology, has an outstanding opportunity for a Clinical Trials Specialist (CTS) to join their team.
POSITION PURPOSE
The Division of Hematology and Oncology is within the Department of Medicine. The Division’s primary mission is to improve cancer care by moving discoveries made in the laboratory to a clinical setting and finding new and innovative ways to use existing therapies. Our vision is to be national leaders in oncology translational medicine. The Division of Hematology and Oncology is primarily located in the Fred Hutchinson Cancer Center (FHCC) campus, but also has faculty and staff located at the University of Washington (UW) Medical Center, Harborview Medical Center, the VA Puget Sound Health Care System, and South Lake Union.
The CTS reports to the Senior Research Implementation Manager and Lead Clinical Trial Specialist. This position interacts closely with multiple process partners, including FHCC and UW clinical and administrative departments, multiple regulatory committees, pharmaceutical companies, Clinical Research Organizations (CROs), and external academic institutions. The CTS is responsible for clinical trial study start up in the Thoracic, Head & Neck and Neuro Oncology program in the Division of Hematology and Oncology and will accelerate clinical trial study start up by developing and optimizing new and ongoing study start-up processes. This position works with minimal supervision and negotiates optimal pricing and payment terms with federal and pharmaceutical sponsors; coordinating the submission of a wide range of study start-up documents including pricing requests to various UW and FHCC departments, developing study budgets, and negotiating study budgets. This position requires the ability to understand clinical research coordination, revenue cycle development, budgeting, compliance, and regulations.
POSITION COMPLEXITIES
The research projects managed by this position are complex. This position requires the ability to integrate information from multiple sources to ensure that all research proposals meet the requirements of the UW, FHCC, the Food and Drug Administration, the National Institutes of Health, and the study sponsor. This position is required to use independent judgment and knowledge of the academic clinical trial business to effectively facilitate the workflow and promote a collaborative work environment.
The CTS will maintain dynamic communication with the study investigators, research staff, UW departments, FHCC departments, and other development partners. There are multiple resources available within the UW and FHCC systems to help in this process, but ultimately, the work must be done with limited assistance and in a resourceful manner to expedite opening clinical trials. This position interacts with representatives from pharmaceutical companies, health care providers and colleagues in a manner that well-represents the University of Washington.
POSITION DIMENSIONS AND IMPACT TO THE UNIVERSITY
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. The CTS is key to the success of the Thoracic, Head & Neck and Neuro Oncology Research Program as timely study start-up is of direct benefit to those we serve. This position will require a strong partnership with faculty and staff within and external to the programs.
DUTIES AND RESPONSIBILITIES
This position must be able to work independently on multiple research projects with minimal written policies or procedures. This position requires daily interaction with pharmaceutical sponsors, physicians, program research team members, and other partners. Up to 8 projects will be in progress simultaneously, with the expectation of additional projects in the future.
Coordinate Clinical Trial Start-up Processes (75%)
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 Thoracic, Head & Neck and Neuro Oncology Research Program, in the Division of Hematology and Oncology, has an outstanding opportunity for a Clinical Trials Specialist (CTS) to join their team.
POSITION PURPOSE
The Division of Hematology and Oncology is within the Department of Medicine. The Division’s primary mission is to improve cancer care by moving discoveries made in the laboratory to a clinical setting and finding new and innovative ways to use existing therapies. Our vision is to be national leaders in oncology translational medicine. The Division of Hematology and Oncology is primarily located in the Fred Hutchinson Cancer Center (FHCC) campus, but also has faculty and staff located at the University of Washington (UW) Medical Center, Harborview Medical Center, the VA Puget Sound Health Care System, and South Lake Union.
The CTS reports to the Senior Research Implementation Manager and Lead Clinical Trial Specialist. This position interacts closely with multiple process partners, including FHCC and UW clinical and administrative departments, multiple regulatory committees, pharmaceutical companies, Clinical Research Organizations (CROs), and external academic institutions. The CTS is responsible for clinical trial study start up in the Thoracic, Head & Neck and Neuro Oncology program in the Division of Hematology and Oncology and will accelerate clinical trial study start up by developing and optimizing new and ongoing study start-up processes. This position works with minimal supervision and negotiates optimal pricing and payment terms with federal and pharmaceutical sponsors; coordinating the submission of a wide range of study start-up documents including pricing requests to various UW and FHCC departments, developing study budgets, and negotiating study budgets. This position requires the ability to understand clinical research coordination, revenue cycle development, budgeting, compliance, and regulations.
POSITION COMPLEXITIES
The research projects managed by this position are complex. This position requires the ability to integrate information from multiple sources to ensure that all research proposals meet the requirements of the UW, FHCC, the Food and Drug Administration, the National Institutes of Health, and the study sponsor. This position is required to use independent judgment and knowledge of the academic clinical trial business to effectively facilitate the workflow and promote a collaborative work environment.
The CTS will maintain dynamic communication with the study investigators, research staff, UW departments, FHCC departments, and other development partners. There are multiple resources available within the UW and FHCC systems to help in this process, but ultimately, the work must be done with limited assistance and in a resourceful manner to expedite opening clinical trials. This position interacts with representatives from pharmaceutical companies, health care providers and colleagues in a manner that well-represents the University of Washington.
POSITION DIMENSIONS AND IMPACT TO THE UNIVERSITY
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. The CTS is key to the success of the Thoracic, Head & Neck and Neuro Oncology Research Program as timely study start-up is of direct benefit to those we serve. This position will require a strong partnership with faculty and staff within and external to the programs.
DUTIES AND RESPONSIBILITIES
This position must be able to work independently on multiple research projects with minimal written policies or procedures. This position requires daily interaction with pharmaceutical sponsors, physicians, program research team members, and other partners. Up to 8 projects will be in progress simultaneously, with the expectation of additional projects in the future.
Coordinate Clinical Trial Start-up Processes (75%)
• Establish and maintain methods to initiate study start-up budget planning.
• Use knowledge of clinical research, medical terminology, and clinical processes to translate complex oncology protocol requirements into clinical trial budgets and facilitate submissions to relevant compliance offices.
• Work with research and finance program managers and faculty to translate study start-up pricing and budget efforts into study tracking.
• Forecast, track and report study start-up timelines.
• Prepare and submit eGC1s in accordance with OSP requirements and deadlines
• Ensure SFI compliance is completed and required approvals are received by OSP deadlines
• Independently negotiate successful clinical trial budgets and payment terms with study sponsors, per the program's set requirements.
• Coordinate and communicate with UW and FHCC offices involved in the review and negotiation of clinical trial budgets and contracts, including UW Clinical Trial Office (CTO), the UW Office of Sponsored Programs (OSP), and the FHCC Clinical Research Support (CRS) office.
• Assist research and finance program managers with developing communicating study start-up metrics and goals.
• Develop and track study start-up pieces and report progress to program managers, faculty, and study team members.
• Produce monthly and quarterly study start-up metric reports using established formats.
Budget and Contract Amendments (25%)
Budget and Contract Amendments (25%)
• Process budget and contract amendments.
• Independently negotiate successful clinical trial budget amendments and payment terms with study sponsors.
• Create new eGC1s, if required, in accordance with OSP policies.
Perform other duties as assigned.
MINIMUM REQUIREMENTS
Perform other duties as assigned.
MINIMUM REQUIREMENTS
• Bachelor's Degree in business, science or health-related field (experience may substitute for education)
• Minimum two years of experience with budget development, clinical research coordination, or related project management or health care experience
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
ADDITIONAL REQUIREMENTS
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
ADDITIONAL REQUIREMENTS
• 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 Office Suite
• 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 90 days of hire.
DESIRED QUALIFICATIONS
DESIRED QUALIFICATIONS
• Experience in an academic medical center
• Experience as research study coordaintor
• Experience in onoclogy 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 regulation
• Strong working knowledge of Microsoft Office Suite
• Experience with REDCap, Clinical Trial Management System (CTMS), UW SAGE, and Epic
WORKING ENVIRONMENTAL CONDITIONS
Fast-paced office environment, with a high volume of often-complex projects. The work may be deadline driven and requires rapid and frequent communications.
This position is located in a clinical and research environment that is located at the Fred Hutchinson Cancer Center. Work hours may exceed 40 hours per week and can be deadline dependent.
Application Process: The application process 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 Work Authorization, 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 access 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.
#UWDeptMedicineJobs
WORKING ENVIRONMENTAL CONDITIONS
Fast-paced office environment, with a high volume of often-complex projects. The work may be deadline driven and requires rapid and frequent communications.
This position is located in a clinical and research environment that is located at the Fred Hutchinson Cancer Center. Work hours may exceed 40 hours per week and can be deadline dependent.
Application Process: The application process 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 Work Authorization, 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 access 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.
#UWDeptMedicineJobs
Salary : $5,417 - $7,084
