Lead Clinical Trials Specialist (Lead CTS)
Apply NowCompany: University of Washington
Location: Seattle, WA 98164
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 Thoracic, Head & Neck and Neuro Oncology Research Program, in the Division of Hematology and Oncology, is looking to hire a Lead Clinical Trials Specialist (Lead CTS).
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. 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 Lead CTS reports to the Senior Research Implementation Manager and 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. This role is responsible for overseeing and facilitating investigator-initiated and pharmaceutical-sponsored trials in start-up, amendments, and contractual and financial maintenance activities across UW and FHCC clinical trials and grant systems. The Lead CTS works with minimal oversight and provides guidance, training, and lead task assignment of Clinical Trial Specialists (CTS) and start-up and budget development staff workloads. This position requires a high level of knowledge of protocol development, clinical research coordination, revenue cycle development, budgeting, compliance, and regulations.
Position Complexities:
The Lead CTS will be responsible for participating in the hiring and training of a Clinical Trial Specialist (CTS) and future start-up and budget development staff. In addition, the Lead CTS will participate in the delegation of trial start-up, amendments, and implementation workloads. The position will provide daily guidance and technical assistance to promote the management and integrity of clinical trial research in the program.
The research projects managed by this position are complex. The Lead CTS 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 must have a high level of experience negotiating optimal budgets and payment terms for federal and pharmaceutical-sponsored research that meets UW established budgeting and billing compliance standards.
The Lead CTS will maintain dynamic communication with the study investigators, research staff, UW and 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 and processing amendments. This position interacts with representatives from pharmaceutical companies, health care providers and colleagues in a manner that well-represents the UW.
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 Lead CTS is key to the success of the Thoracic, Head & Neck and Neuro Oncology Research Program as timely study start-up and amendment processing is of direct benefit to those we serve. This position will require a strong partnership with faculty and staff and external stakeholders.
DUTIES AND RESPONSIBILITIES
Coordinate clinical trial start-up processes (40%)
Establish and maintain methods to initiate study start-up budget and implementation planning, delegate tasks and provide forecasting of start-up workloads.
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.
Create Advanced Budget Numbers and work tags.
Guide regulatory staff for timing of necessary submissions (Scientific Review Committee, UW Human Subjects Division, Radiation Safety, FDA submissions, and IRB submissions), in order to meet projected start-up 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.
Coordinate with UW and FHCC offices and clinical areas to arrange for clinical services and orders.
Produce monthly and quarterly study start-up metric reports using established formats.
Budget and Contract Amendments (30%)
Review protocol amendments and new study materials for changes that impact billing, budget and research orders that impact clinical and financial implementation.
Process budget and contract amendments and order changes per UW and FHCC systems.
Work with regulatory team to coordinate implementation of new amendments and study documents.
Independently negotiate successful clinical trial budget amendments and payment terms with funder.
Create new eGC1s and budgets, if required, in accordance with UW OSP policies.
Lead Tasks (15%)
Assist in the hiring and training of the CTS and other start-up and budget development staff hired.
Act as a subject matter expert and provide technical guidance.
Work with the Senior Research Implementation Manager to review workloads and delegate tasks.
Track workloads and timelines, report findings to Senior Research Implementation Manager.
Integrity, Compliance and Oversight (15%)
Work with the program managers to identify areas for process improvements in subject tracking and charge capture.
Collaborate with program managers to address internal budget and subject tracking audit findings.
Develop and manage guidelines that standardize start-up, amendments and implementation workflows.
Perform other duties as assigned.
MINIMUM REQUIREMENTS
Bachelor's Degree in Business, Science or Health-related field (experience may substitute for education). A minimum of 3 years experience with budget development, clinical research coordination, or related project management or health care experience.
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
Experience in an academic medical center.
Experience as 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 regulation.
Strong working knowledge of Microsoft Office Suite.
Experience with REDCap, Clinical Trial Management System (CTMS), UW SAGE, and Epic.
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
CONDITIONS OF EMPLOYMENT
Fast-paced office environment, with a high volume of often-complex projects. The work may be deadline driven and requires rapid and requent 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.
Committed to attracting and retaining a diverse staff, the University of Washington will honor your experiences, perspectives and unique identity. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable and welcoming.
The University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran or disabled status, or genetic information.
To request disability accommodation in the application process, contact the Disability Services Office at [redacted] or [redacted].
Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law.
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, is looking to hire a Lead Clinical Trials Specialist (Lead CTS).
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. 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 Lead CTS reports to the Senior Research Implementation Manager and 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. This role is responsible for overseeing and facilitating investigator-initiated and pharmaceutical-sponsored trials in start-up, amendments, and contractual and financial maintenance activities across UW and FHCC clinical trials and grant systems. The Lead CTS works with minimal oversight and provides guidance, training, and lead task assignment of Clinical Trial Specialists (CTS) and start-up and budget development staff workloads. This position requires a high level of knowledge of protocol development, clinical research coordination, revenue cycle development, budgeting, compliance, and regulations.
Position Complexities:
The Lead CTS will be responsible for participating in the hiring and training of a Clinical Trial Specialist (CTS) and future start-up and budget development staff. In addition, the Lead CTS will participate in the delegation of trial start-up, amendments, and implementation workloads. The position will provide daily guidance and technical assistance to promote the management and integrity of clinical trial research in the program.
The research projects managed by this position are complex. The Lead CTS 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 must have a high level of experience negotiating optimal budgets and payment terms for federal and pharmaceutical-sponsored research that meets UW established budgeting and billing compliance standards.
The Lead CTS will maintain dynamic communication with the study investigators, research staff, UW and 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 and processing amendments. This position interacts with representatives from pharmaceutical companies, health care providers and colleagues in a manner that well-represents the UW.
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 Lead CTS is key to the success of the Thoracic, Head & Neck and Neuro Oncology Research Program as timely study start-up and amendment processing is of direct benefit to those we serve. This position will require a strong partnership with faculty and staff and external stakeholders.
DUTIES AND RESPONSIBILITIES
Coordinate clinical trial start-up processes (40%)
Budget and Contract Amendments (30%)
Lead Tasks (15%)
Integrity, Compliance and Oversight (15%)
Perform other duties as assigned.
MINIMUM REQUIREMENTS
Bachelor's Degree in Business, Science or Health-related field (experience may substitute for education). A minimum of 3 years experience with budget development, clinical research coordination, or related project management or health care experience.
ADDITIONAL REQUIREMENTS
DESIRED QUALIFICATIONS
CONDITIONS OF EMPLOYMENT
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.
Committed to attracting and retaining a diverse staff, the University of Washington will honor your experiences, perspectives and unique identity. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable and welcoming.
The University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran or disabled status, or genetic information.
To request disability accommodation in the application process, contact the Disability Services Office at [redacted] or [redacted].
Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law.