Clinical Trial Specialist

Job Description

CLINICAL TRIAL SPECIALIST

Req #: 240792 Department: DEPARTMENT OF MEDICINE: HEMATOLOGY & ONCOLOGY Appointing Department Web Address: https://hemonc.uw.edu Job Location: Remote/Hybrid Job Location Detail: Will consider 100% remote working arrangement. Posting Date: 11/13/2024 Closing Info: Open Until Filled Salary: $6,752 - $8,834 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 Division of Hematology and Oncology has an outstanding opportunity for a Clinical Trial Specialist to join their team.
POSITION PURPOSE
The purpose of the Clinical Trial Specialist position is to promote the research objectives of the Hematologic Malignancy Program in the Division of Oncology. This position will be responsible for independently processing protocol amendments, negotiating budget amendments, facilitating contract amendment execution, and managing the clinical trial start-up process for pharmaceutical-sponsored and investigator-initiated clinical trials. Additionally, they will collaborate with Research Coordinators and Program Leadership to create and update source documents for clinical trials, and implement workflows that allow for protocol adherence, data integrity, and ensure efficiency and compliance.
The Clinical Trial Specialist will maintain daily and dynamic communication with the study investigators, research staff, University departments, Fred Hutchinson Cancer Center (FHCC) departments, and pharmaceutical sponsors.
This position is required to use independent judgment, leadership and knowledge of academic clinical trials to effectively facilitate processing of protocol amendments, budget/contract amendments, and study start-up workflow while promoting a collaborative work environment. This position requires the ability to understand clinical research coordination, revenue cycle development, budgeting, compliance, and regulations. The Clinical Trial Specialist is supervised by and reports to the Hematologic Malignancy Research Manager.
POSITION COMPLEXITIES
This position is required to constantly integrate information from multiple sources to ensure smooth and expeditious execution and implementation of administrative protocol amendments, budget/contract amendments, and start-up of clinic trials. Work must be completed in a manner that meet the requirements of the University, the Food and Drug Administration, the National Institutes of Health and the study sponsors. There are multiple resources available within the University system (e.g. Grant and Contract Services, Institutional Review Board, Office of Industry Relations) to help in this process, but ultimately, the work must be done independently and in a resourceful manner to expedite the Division's research objectives. This position interacts with representatives from pharmaceutical companies, health care providers and institutional department leadership in a manner that well-represents the University of Washington and Fred Hutchinson Cancer Center (FHCC).
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 Hematologic Malignancy Program in the Division of Oncology. It is responsible to manage processing of budget/contract amendments, and the clinical trial start up process, the majority of which provide significant financial support for the Division of Oncology. In the Hematologic Malignancy group, this translates into $8.6 million dollars.
DUTIES AND RESPONSIBILITIES
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 institutional departments. Up to 15 projects will be in progress simultaneously, with the expectation of additional projects in the future.
Budget and Contract Amendments (80%)

Receive and process budget amendments and other protocol documents from clinical trial sponsors.

Assist with development and implementation of protocol amendments and protocol documents for investigator-initiated trials.

Review study calendars, billing grids, and budget entry information within the Clinical Trial Management System (CTMS) to ensure efficient and compliant research revenue cycle operations.

Process budget and contract amendments by independently negotiating successful clinical trial budget amendments and payment terms with study sponsors.

Create new eGC1s, if required, for budget/contract amendment processing in accordance with OSP policies.

Partner with Research Manager, faculty, and fiscal staff to strengthen clinical research revenue cycle operations, ensuring smooth and efficient functioning with a goal of standardization.

Develop tools and metrics to track and analyze implemented process for improvements.

Interpret, analyze, and implement all institutional, state, and federal policies relates to clinical research fiscal cycle administration including Medicare Clinical Trials Policy and Medicare Secondary Payer Rule; function as subject matter expert on such policies.

Other duties/projects, as assigned
Manage Clinical Trial Start-up Processes (10%)

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 the CTMS study calendar, BG, clinical trial budgets and facilitate submissions to relevant offices.

Forecast, track, and report study start-up timelines/progress to Hematologic Malignancies Managers, Leads, faculty, and study team members.

Prepare and submit eGC1s for new study contracts/budgets 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 that support program goals.

Coordinate and communicate with UW and FHCC offices involved in the review and negotiation of clinical trial budgets and contracts, including UW Clinical Research Budget and Billing office, the UW Office of Sponsored Programs, the FHCC Clinical Trial Management Office, and the FHCC Clinical Operations-Research Services.

Guide regulatory staff for timing of necessary submissions (Scientific Review Committee, UW Human Subjects Division, Radiation Safety, FDA submissions, and IRB submissions), to meet projected start-up deadlines.

Assist Hematologic Malignancies Managers and Leadership with developing start-up tools and metric tracking.

Other duties/projects, as assigned
Protocol Implementation, Education and Communication (10%)

Collaborate with Hematologic Malignancies Managers and Leads to design, create and revise research instruments (e.g. case report forms and source documents) as necessary to ensure quality data that satisfies research objectives, protocol adherence, data integrity, and ensures efficiency/compliance.

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).

Design, develop, document and maintain policies and procedures for protocol implementation to ensure that research execution meets Good Clinical Practice guidelines.

Assist the Research Manager to develop and maintain standardized research procedures that ensure Program compliance with FDA, State, and inter-institutional regulations.

Assist the Research Manager to develop and maintain research procedures for the Program with the goal of standardization, increased efficiency, and ensuring compliance with Institutional guidelines.

Develop and lead on-going education regarding research budgeting and billing policies, regulations, and compliance matters.

Other duties/projects as assigned.
MINIMUM REQUIREMENTS

Bachelor's Degree in science or health-related field

Minimum three years' experience with clinical research coordination or related project management or healthcare experience
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
ADDITIONAL REQUIREMENTS

Demonstrated knowledge of FDA and NIH requirements relating to research involving human subjects

Ability to work in a fast-pace clinical research program

Strong attention to detail

Excellent written and verbal communication skills (i.e., ability to communicate effectively both verbally and in writing, and to work effectively with colleagues and study sponsor representatives)

Strong organization skills and demonstrated ability to prioritize multiple projects, simultaneously
DESIRED QUALIFICATIONS

Prior working experience at the UWMC and/or FHCC.

Experience working in a clinical environment with oncology patients

Experience in oncology clinical trial development, implementation and analysis

Knowledge of OnCore CTMS software.

Experience developing clinical trial budgets

Experience working in an academic medical center environment
CONDITIONS OF EMPLOYMENT

This position requires a flexible work schedule, with at least 40 hours worked per week.

Stringent deadlines from pharmaceutical companies for protocol implementation and data collection may require overtime.

Occasional evening and weekend work is required.

This position is 100% remote.
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.
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