Lead Clinical Trials Specialist -- Department of Medicine, Division of Hematology & Oncology

Job Description

The Department of Medicine, Division of Hematology & Oncology has an outstanding opportunity for a Lead Clinical Trials Specialist (Research Coordinator 3) to join their Thoracic, Head & Neck Oncology Clinical Trials Research Program.

About this Opportunity

Reporting to the Clinical Research Implementation Project Manager of the UW Thoracic, Head &  Neck Oncology Research (THOR) Program, the Lead Clinical Trials Specialist (CTS) (Research Coordinator 3) provides operational leadership for investigator-initiated and industry-sponsored clinical trials, overseeing study start-up, protocol amendments, contract execution, budget development, and ongoing financial and regulatory maintenance across UW and FHCC clinical trials and grants management systems. This role is a fully functional, professional research coordinator that provides daily guidance and technical assistance to promote management, integrity, and continual improvement of work practices of clinical trial research in the program. This position serves as a key liaison across multiple stakeholders, including FHCC and UW clinical and administrative departments, regulatory committees, pharmaceutical sponsors, Clinical Research Organizations (CROs), and external academic institutions. This position will engage with multiple clinical trials simultaneously, with the expectation of additional projects in the future.

The Lead Clinical Trials Specialist works on-site at the Fred Hutch Cancer Center (FHCC), and project work visits may be required during the work shift at local affiliate locations. The position may be eligible to be considered for a hybrid telework work schedule based on business needs, working remotely up to two day per week, once fully trained and demonstrating telework readiness.

Key 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 program leadership and faculty to ensure appropriate study start-up pricing and budget efforts into study tracking.
• Independently negotiate successful clinical trial budgets and payment terms with study sponsors, per the program's set requirements.
• 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.
• 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.
• Prepare and submit eGC1s in accordance with CTO requirements and deadlines.
• Ensure SFI compliance is completed and required approvals are received by CTO deadlines.
• Create Advanced Budget Numbers and work tags.
• Assist research and finance program managers with developing communicating study start-up metrics and goals.
• Forecast, track and report study start-up timelines.
• Produce monthly and quarterly study start-up metric reports using established formats.
• Coordinate with UW and FHCC offices and clinical areas to arrange for clinical services and orders.

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 CTS and other start-up and budget development staff hired.
• Act as a subject matter expert and provide technical guidance.
• Work with program leadership to review workloads and delegate tasks.
• Track workloads and timelines, report findings to program leadership.

Integrity, Compliance and Oversight (15%)

• Work with the program leadership to identify areas for process improvements in subject tracking and charge capture.
• Collaborate with program leadership to address internal budget and subject tracking audit findings.
• Develop and manage guidelines that standardize start-up, amendments and implementation workflows.

Perform other related duties as assigned.

Required Qualifications

To be considered for this opportunity your application must demonstrate you meet both the minimum qualifications and additional qualifications listed below. Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.

Minimum Qualifications

• Bachelor’s degree in a related field and four years of relevant experience.
• Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.

Applicants who do not meet these minimum qualifications WILL NOT be forwarded to the Hiring Manager.

Additional Qualifications

• Experience with budget development, clinical research coordination, or related project management or health care experience.
• Demonstrated ability to work and communicate effectively and efficiently in a group environment and with all levels of faculty, management, and clinical research staff
• Exceptional organizational and customer service skills.
• Strong attention to detail and ability to multitask and independently organize and prioritize multiple projects. 
• Strong written and verbal presentation skills.
• 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.
• Strong computer skills; competency with Microsoft Office suite.
• Ability to multi-task and adjust to rapidly changing priorities and new projects, while maintaining positive attitude and professional demeanor under potentially stressful situations. 

Preferred Qualifications

• Experience as research study coordinator in an academic medical center and/or 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 REDCap, Clinical Trial Management System (CTMS), UW SAGE, and Epic.

Working Conditions

• This position is in a clinical and research setting that is located on the Fred Hutch Cancer Center campus and may require workday travel between local affiliate locations.
• There may be meetings or appointments over which an individual has no control and that require a flexible schedule in order to accommodate, such as patient coordination needs, study sponsor deadlines, research program needs, grant deadlines, and faculty needs. Work hours may exceed 40 hours per week and can be deadline dependent.
• This position will 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. Several projects will be in progress simultaneously, with the expectation of additional projects in the future.
• Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to complete this training within 30 days of hire.

About the Team

The University of Washington's Division of Hematology & Oncology includes 200+ staff members and 450+ faculty members located at the UW Medical Center (UWMC), the Fred Hutch Cancer Center (FHCC), and the VA Puget Sound Health Care System. As the premier hematology/oncology program in the Pacific Northwest, we balance the twin aims of innovative, life-saving research and knowledge-driven, patient-focused cancer care. Over the past 40 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.

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Compensation, Benefits and Position Details

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About the UW 

Working at the University of Washington provides a unique opportunity to change lives – on our campuses, in our state and around the world.  

UW employees bring their boundless energy, creative problem-solving skills and dedication to building stronger minds and a healthier world. In return, they enjoy outstanding benefits, opportunities for professional growth and the chance to work in an environment known for its diversity, intellectual excitement, artistic pursuits and natural beauty. 

Our Commitment 

The University of Washington is committed to fostering an inclusive, respectful and welcoming community for all. As an equal opportunity employer, the University considers applicants for employment without regard to race, color, creed, religion, national origin, citizenship, sex, pregnancy, age, marital status, sexual orientation, gender identity or expression, genetic information, disability, or veteran status consistent with UW Executive Order No. 81.

To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or dso@uw.edu. 

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.