University of Washington
CLINICAL TRIAL START-UP COORDINATOR
University of Washington, Seattle, Washington, us, 98127
Req #: 239618
Department: HEMATOLOGY AND ONCOLOGY
Appointing Department Web Address: https://hemonc.uw.edu/
Job Location Detail: Fred Hutchinson Cancer Center
Posting Date: 11/04/2024
Closing Info: Open Until Filled 11/11/2024
Salary: $6,000 - $7,084 per month
Shift: First Shift
Notes: 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. (https://hr.uw.edu/benefits/wp-content/uploads/sites/3/2018/02/benefits-professional-staff-librarians-academic-staff-20230701_a11y.pdf)
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 Department of Hematology and Oncology has an outstanding opportunity for a Clinical Trial Start-Up Coordinator to join their team. POSITION PURPOSE
This position is responsible for the clinical research start-up processes for industry-sponsored and investigator-initiated clinical trials in the Division of Hematology and Oncology. This position works with Acute Leukemia, MDS/MPN, and Classical Hematology disease group faculty. This position will accelerate clinical research start-up by developing and optimizing new and ongoing study start-up processes. This position requires thorough understanding of the clinical research process and the ability to integrate this knowledge with research priorities to develop strong and robust study budgets. This position will shepherd studies through internal and external study start-up processes and approvals.
POSITION COMPLEXITIES
This position will shepherd clinical research studies through the implementation process within the Hematology Clinical Research group at the UW/FH Cancer Consortium. This position will coordinate the submission of a wide range of study start-up documents to various UW and FHCC departments, develop and amend study budgets, and staying current with numerous University, sponsor, Medicare, and FDA policies, guidelines, and related procedures.
This position is required to use independent judgment and knowledge of the academic clinical trial business to effectively facilitate workflow and promote a collaborative work environment. The position will maintain dynamic communication with study investigators, research staff, numerous UW and FHCC departments, and other development partners (other universities, federal, and industry partners).
This position is required to integrate knowledge from multiple sources to ensure that all study start-up proposals meet the requirements of the UW, FHCC, the UW/FH Cancer Consortium, and external agencies, institutions, and industry sponsors. This position is required to coordinate efforts and provide information across the Cancer Consortium partners including UW and FHCC departments and staff.
This position is key to the success of the Hematology Clinical Research Program and promotes timely study start-up of hematology oncology and benign hematology clinical trials. It requires a strong partnership with faculty and staff within and external to the program.
This position will report to the Hematology Clinical Research Manager.
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. This position provides significant contributions to research development, implementation and analysis for the Division of Hematology and Oncology. It is responsible for overseeing the management of clinical trials.
DUTIES AND RESPONSIBILITIES
This position must be able to work independently under administrative direction 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 and other regulatory authorities, other health care personnel (e.g. nurses, patient care coordinators, insurance companies).
Clinical trial start-up processes (70%)
Establish confidentiality disclosures between UW and industry sponsors, and partner with the UW Office of Sponsored Programs to ensure appropriate documents are in place.
Review clinical trial protocols for feasibility and site selection forms; communicate with Sponsors about site capabilities. Coordinate facility tours and visits with sponsors to demonstrate site qualification.
Triage and review site selection letters and receipt of comprehensive start-up package.
Create, update, and maintain Clinical Trial Management Systems entries for all protocols.
Facilitate submission of new study start-up documents to relevant offices within UW and FHCC departments.
Interpret complex human subject protocols, with a thorough understanding of medical terminology and clinical processes, to determine adequate budgeting for protocol tasks and assessments, including invoiceable and pass-through items, to develop budgets that are self-sustaining. Ensures that budgets meet compliance standards for both clinical and financial aspects. Assess impacts to clinical operations.
Review and approve all clinical trial study visit calendars, protocol assessment billing designations, and protocol specific details in the institution’s Clinical Trial Management System.
Ensure clinical trial registration with the appropriate service areas, develop clinical trial management and tracking documents, create protocol-specific workflow and checklist tools.
Collaborate with Regulatory Coordinators to ensure appropriate regulatory approvals are in place, and training and delegations are completed.
Forecast, track and report study start-up timelines.
Develop and track study start-up report progress, with metrics, to Research Managers, faculty, and study team members.
Train and guide study team members regarding CTMS entry requirements for correct post-award invoicing and to accurately interpret clinical trial budgets for proper invoice approval.
Assess new protocol amendments and identify impacts to study calendars, billing grids, and budgets. Amend existing study budgets to support changes in protocol and/or correct errors.Protocol implementation (25%)
Collaborate with UW and FHCC clinical teams to assess how to implement protocol in relevant service areas.
Independently develop and implement research project procedures and tools that meet research objectives and ensure compliance with all aspects of Institution, Sponsor, FDA, NIH regulations pertaining to clinical research in human subjects. 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.
Use knowledge of clinical research, medical terminology, and clinical processes to interpret complex protocol requirements, review for clinical feasibility, and identify requirements that will impact clinical implementation.
Coordinate and oversee vendor access for clinical trial databases, pharmacy dispensation systems, image submission systems, etc, as needed prior to study activation.
Schedule and oversee Site Initiation Visits for clinical trial activation.Perform other duties as assigned (5%) MINIMUM REQUIREMENTS
Bachelor's degree in science or health-related field
At least two years of experience Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration. ADDITIONAL REQUIREMENTS
Clinical research working with human subjects.
Working in hematology and/or oncology.
Experience working within the UW/FHCC setting.
Familiarity with Epic electronic health record system.
Knowledge of HIPAA regulations, GSP and HSD training, and FDA guidelines relating to research involving human subjects.
Strong attention to detail and ability to multi-task, organize, and prioritize projects and competing deadlines.
Excellent written and verbal communication skills.
Strong computer skills and competency with Microsoft Office software. CONDITITONS OF EMPLOYMENT Sitting at desk for majority of hours worked; working on a computer and on the telephone in a cubicle in a public area with little privacy. Ability to multi-task and be flexible while maintaining a professional demeanor is crucial as priorities change throughout each day. May respond to multiple requests for information (e-mail, voicemail, fax, verbal), determining priorities. Flexible work schedule. Stringent deadlines from sponsors and faculty for protocol implementation may require overtime. Some evening and weekend travel to study meetings and sites may be required.This position is located in a clinical research environment at the Fred Hutchinson Cancer Center campus and requires the physical ability to get between offices, clinic, and other facilities, up to 1-mile distance. 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.
University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sexual orientation, gender identity, sex, age, protected veteran or disabled status, or genetic information.
Department: HEMATOLOGY AND ONCOLOGY
Appointing Department Web Address: https://hemonc.uw.edu/
Job Location Detail: Fred Hutchinson Cancer Center
Posting Date: 11/04/2024
Closing Info: Open Until Filled 11/11/2024
Salary: $6,000 - $7,084 per month
Shift: First Shift
Notes: 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. (https://hr.uw.edu/benefits/wp-content/uploads/sites/3/2018/02/benefits-professional-staff-librarians-academic-staff-20230701_a11y.pdf)
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 Department of Hematology and Oncology has an outstanding opportunity for a Clinical Trial Start-Up Coordinator to join their team. POSITION PURPOSE
This position is responsible for the clinical research start-up processes for industry-sponsored and investigator-initiated clinical trials in the Division of Hematology and Oncology. This position works with Acute Leukemia, MDS/MPN, and Classical Hematology disease group faculty. This position will accelerate clinical research start-up by developing and optimizing new and ongoing study start-up processes. This position requires thorough understanding of the clinical research process and the ability to integrate this knowledge with research priorities to develop strong and robust study budgets. This position will shepherd studies through internal and external study start-up processes and approvals.
POSITION COMPLEXITIES
This position will shepherd clinical research studies through the implementation process within the Hematology Clinical Research group at the UW/FH Cancer Consortium. This position will coordinate the submission of a wide range of study start-up documents to various UW and FHCC departments, develop and amend study budgets, and staying current with numerous University, sponsor, Medicare, and FDA policies, guidelines, and related procedures.
This position is required to use independent judgment and knowledge of the academic clinical trial business to effectively facilitate workflow and promote a collaborative work environment. The position will maintain dynamic communication with study investigators, research staff, numerous UW and FHCC departments, and other development partners (other universities, federal, and industry partners).
This position is required to integrate knowledge from multiple sources to ensure that all study start-up proposals meet the requirements of the UW, FHCC, the UW/FH Cancer Consortium, and external agencies, institutions, and industry sponsors. This position is required to coordinate efforts and provide information across the Cancer Consortium partners including UW and FHCC departments and staff.
This position is key to the success of the Hematology Clinical Research Program and promotes timely study start-up of hematology oncology and benign hematology clinical trials. It requires a strong partnership with faculty and staff within and external to the program.
This position will report to the Hematology Clinical Research Manager.
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. This position provides significant contributions to research development, implementation and analysis for the Division of Hematology and Oncology. It is responsible for overseeing the management of clinical trials.
DUTIES AND RESPONSIBILITIES
This position must be able to work independently under administrative direction 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 and other regulatory authorities, other health care personnel (e.g. nurses, patient care coordinators, insurance companies).
Clinical trial start-up processes (70%)
Establish confidentiality disclosures between UW and industry sponsors, and partner with the UW Office of Sponsored Programs to ensure appropriate documents are in place.
Review clinical trial protocols for feasibility and site selection forms; communicate with Sponsors about site capabilities. Coordinate facility tours and visits with sponsors to demonstrate site qualification.
Triage and review site selection letters and receipt of comprehensive start-up package.
Create, update, and maintain Clinical Trial Management Systems entries for all protocols.
Facilitate submission of new study start-up documents to relevant offices within UW and FHCC departments.
Interpret complex human subject protocols, with a thorough understanding of medical terminology and clinical processes, to determine adequate budgeting for protocol tasks and assessments, including invoiceable and pass-through items, to develop budgets that are self-sustaining. Ensures that budgets meet compliance standards for both clinical and financial aspects. Assess impacts to clinical operations.
Review and approve all clinical trial study visit calendars, protocol assessment billing designations, and protocol specific details in the institution’s Clinical Trial Management System.
Ensure clinical trial registration with the appropriate service areas, develop clinical trial management and tracking documents, create protocol-specific workflow and checklist tools.
Collaborate with Regulatory Coordinators to ensure appropriate regulatory approvals are in place, and training and delegations are completed.
Forecast, track and report study start-up timelines.
Develop and track study start-up report progress, with metrics, to Research Managers, faculty, and study team members.
Train and guide study team members regarding CTMS entry requirements for correct post-award invoicing and to accurately interpret clinical trial budgets for proper invoice approval.
Assess new protocol amendments and identify impacts to study calendars, billing grids, and budgets. Amend existing study budgets to support changes in protocol and/or correct errors.Protocol implementation (25%)
Collaborate with UW and FHCC clinical teams to assess how to implement protocol in relevant service areas.
Independently develop and implement research project procedures and tools that meet research objectives and ensure compliance with all aspects of Institution, Sponsor, FDA, NIH regulations pertaining to clinical research in human subjects. 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.
Use knowledge of clinical research, medical terminology, and clinical processes to interpret complex protocol requirements, review for clinical feasibility, and identify requirements that will impact clinical implementation.
Coordinate and oversee vendor access for clinical trial databases, pharmacy dispensation systems, image submission systems, etc, as needed prior to study activation.
Schedule and oversee Site Initiation Visits for clinical trial activation.Perform other duties as assigned (5%) MINIMUM REQUIREMENTS
Bachelor's degree in science or health-related field
At least two years of experience Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration. ADDITIONAL REQUIREMENTS
Clinical research working with human subjects.
Working in hematology and/or oncology.
Experience working within the UW/FHCC setting.
Familiarity with Epic electronic health record system.
Knowledge of HIPAA regulations, GSP and HSD training, and FDA guidelines relating to research involving human subjects.
Strong attention to detail and ability to multi-task, organize, and prioritize projects and competing deadlines.
Excellent written and verbal communication skills.
Strong computer skills and competency with Microsoft Office software. CONDITITONS OF EMPLOYMENT Sitting at desk for majority of hours worked; working on a computer and on the telephone in a cubicle in a public area with little privacy. Ability to multi-task and be flexible while maintaining a professional demeanor is crucial as priorities change throughout each day. May respond to multiple requests for information (e-mail, voicemail, fax, verbal), determining priorities. Flexible work schedule. Stringent deadlines from sponsors and faculty for protocol implementation may require overtime. Some evening and weekend travel to study meetings and sites may be required.This position is located in a clinical research environment at the Fred Hutchinson Cancer Center campus and requires the physical ability to get between offices, clinic, and other facilities, up to 1-mile distance. 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.
University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sexual orientation, gender identity, sex, age, protected veteran or disabled status, or genetic information.