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The Division of Cardiology has an outstanding opportunity for a full-time Program Operations Specialist. The purpose of this position is to manage and administer the grant and financial operations of the Clinical Trials Unit (CTU) in the Division of Cardiology as well as grant and financial portfolios of Clinical Trial faculty/investigators (20+). The CTU is currently composed of the faculty program head, one research manager, three supervisors (regulatory, device and drug), and nine research staff. The Program Operations Specialist is an active member of the Cardiology Finance and Grants Team and the CTU workgroup comprised of Clinical Trial investigators and staff developed to assess and drive process improvement in the management of clinical trials within the Division of Cardiology.
The Program Operations Specialist (POS) is required to use independent judgment, strong leadership skills, and knowledge of clinical trial business operations to effectively facilitate work flow and promote a collaborative work environment. This position will maintain dynamic communication with principal investigators, steering committees, vendors, industry sponsors, federal agencies, program and other division staff, and numerous university departments. The POS will act independently and on behalf of the program by applying knowledge of institutional, divisional, federal, and state policies and regulations. This POS will advise faculty of rules and regulations of the University of Washington and various granting agencies and ensure compliance with those rules.
This position reports to the CTU Faculty Program Head and Research Manager and is supervised by the Grants and Contracts Manager/Specialist. Functional areas include grant and contract administration, clinical trial post-award performance, gift processing, and oversight of the financial operations for Division of Cardiology faculty utilizing the services of the Cardiology Clinical Trials Unit. Work of this position is evaluated in terms of adherence to program goals, budgetary limitations, and compliance with laws, regulation and general institutional policies.
The successful candidate for this position will develop and maintain expertise in managing in clinical trial finances as well as pre- and post-award management. This position requires a large amount of self-reliance, self-ruling and autonomy. The Program Operations Specialist will maintain dynamic communication with principal investigators, steering committees, vendors, industry sponsors, federal agencies, program and other division staff, as well as numerous university departments. The POS will act independently and on behalf of the program by applying knowledge of institutional, divisional, federal, and state policies and regulations.
This position is constantly required to integrate information from multiple sources to ensure that all grant proposals meet the requirements of the University of Washington and external agencies, institutions and industry. This position requires independent decision making on key aspects of program operations including budget and finance, purchasing, and fiscal compliance. The Department of Medicine is committed to the goals and mission of the School of Medicine and the University. This position supports the teaching and research activities by assisting the Division of Cardiology, specifically the Cardiology Clinical Trials Unit. This position will provide program financial management support specifically towards these efforts including funding management for a portfolio totaling approximately 4 million dollars.
DUTIES & RESPONSIBILITIES:
The Program Operations Specialist is independently responsible for overall financial management of the CTU program and faculty funding portfolios totaling in more than $4M and includes sponsored research, gifts, surplus, discretionary, endowments, and operational funds. This position serves as the program’s expert on University, state and federal regulations and conditions, and works with clinical trial research staff and faculty to operate effectively within those guidelines. This key role will work directly with the Program Director, grants and finance team, research staff and faculty, industry sponsors, outside institutions, and relevant UW offices to develop agreements, manage revenue and expenditures, report on the program finances, propose and to manage strategic initiatives to optimize the program’s financial wellbeing.
Establishes processes to oversee the financial operations of the CTU program, ensuring financial accountability and compliance, and provides key information, regular reports and analysis, informing program decision making.
Analyzes and interprets study contract documents (inclusive of amendments) and create appropriate study cost projections and visit trackers. Works closely with research staff to make sure startup, on-study and closeout processes are appropriately set up and executed.
Establishes, manages and evaluates complex faculty and staff salary allocations. Ensures salary allocations are in compliance with University and granting organizations’ regulations. In tandem with the CTU Research Manager, manages staff salary allocations for all studies.
Maintains invoicing system and manages issuing and receipt of invoices for all contracts in the portfolio.
Ensures proper billing of UWP hospital charges and research charges. Represents the program’s interest with UWP and other hospital entities on all issues related to clinical billing.
Prepares and provides regular faculty funding-portfolio reports. Prepares regular programmatic financial reports for upper-level management. Organizes and moderates CTU Operations and CTU Leadership meetings.
Holds regular and frequent meetings with assigned faculty, research staff and CTU Leadership to discuss study and portfolio finances.
Serves as an essential member of the Division Finance team by contributing to Division policies and procedures, operational decision making, and serving as a peer resource for other program managers.
Serve as the primary finance team resource and trainer for clinical trial management within the Division of Cardiology.
Management of the Cardiology Clinical Trials Unit requires excellent interpersonal, verbal, and written communication skills and the ability to independently assess projects and workload in order to prioritize and manage tasks and timelines. Responsibilities include:
Conducts business planning and performance reporting. Provides reports and analyses during monthly program meetings to the Faculty Program Head and to the Division Head to support program decision making. Identifies risks and opportunities, and makes recommendations to faculty and the program head that support operating goals.
Organizes and contributes to strategic planning initiatives. Prepares and presents information to and on behalf of the program.
Works closely with other UW Cardiology and Heart Institute partners to ensure successful and smooth functioning of the Cardiology Clinical Trials Unit.
Drafts and composes internal and external communications about the program on behalf of the Program Head.
Develops tools and metrics to track and analyze implemented process improvements. Identifies risks and opportunities. Makes recommendations to program leadership that support its operating goals.
Ensures compliance with University regulations that govern the activities of the Cardiology Clinical Trials Unit and the Division of Cardiology.
A person in this position should keep up-to-date with activities of research staff.
Grant & Contract Management:
Manages all pre- (grant and contract application preparation and submission) and post-award (funds, compliance and reporting management) activities of 20+ Clinical Trial faculty for foundation, federal research grants, and clinical contracts in compliance with University, State and sponsor standards for the Clinical Trials Unit. Additional responsibilities to include:
Develops and prepares complex budgets, graphs, figures, and other administrative sections of proposals for grants and contracts based on knowledge of sponsor requirements and program objectives. Prepares eGC-1, ASSIST, AHA portal and other sponsor platforms for application submission.
Ensures that budget proposals are adequate to meet the financial operating needs of the program and account for all procedural and resource costs. Reviews and provides feedback on CTU study feasibility budgets.
Assists faculty in preparing all documents including the science and business items being submitted to grant application. Ensures all required items (bio-sketches, letters of support, etc.) are included in submission.
Manages and oversees post-award responsibilities including preparing annual progress reports (i.e. NIH RPPRs) and final status reports for grants and contracts in partnership with the faculty and Division staff.
Works with faculty to review and provide recommendations on proposals for potential IRB, IACUC and SFI compliance issues.
Assesses and analyzes opportunities and leads changes to enhance the research revenue cycle process by streamlining processes and improving efficiencies.
Maintains up to date knowledge of research-related University, Federal and State regulations inclusive of federal cost principles per OMB regulations.
Builds and maintains professional working relationships with industry sponsors, national funding agencies and administrative offices on campus such as, but not limited to NIH, NHLBI, American Heart Association, Clinical Research Budget and Billing (CRBB), Grant and Contract Accounting (GCA), and the Office of Sponsored Programs (OSP).
Serve as the primary grants and finance team resource and trainer for clinical trial management within the Division of Cardiology.
Other Projects as assigned
Assists principal investigators and study team with preparation and analysis of study data for publication and grant preparation
Participates in Division-wide workgroups, teams and projects.
This position has program leadership responsibilities for the electronic, written, and verbal communications with a variety of sponsors, faculty, staff, professional organizations, patients, and with the general public.
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.
Bachelor’s Degree in Business Administration, Public Administration or other applicable field and 2 years related experience
Advanced skills and work experience, particularly with Excel but also with Microsoft Office, PowerPoint, and financial and scheduling software
Ability to work independently and make decisions as necessary; ability to manage multiple priorities and to coordinate projects in a complex organization
Knowledge of administrative requirements of clinical research projects.
Comprehensive knowledge of FDA and ICH guidelines, Standard Operating Procedures (SOP), and Good Clinical Practice (GCP).
Highly organized, service-oriented, team-oriented, flexible, and resourceful
Strong organizational, communication (written and verbal) and problem-solving skills
Strong attention to detail
Ability to prioritize and handle multiple tasks on a frequent basis
Ability to thrive in a fast-paced environment that often requires responding to deadlines with short lead times
Ability to interact with people from diverse backgrounds
Ability to periodically work outside of normal business hours (including weekends) to meet deadlines
Demonstrated ability to effectively interact with faculty, staff and students, and vendors, and federal and industry representatives
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
Understanding of theoretical objectives of clinical research projects.
Experience working with UW fiscal and administrative systems and departments.
Experience in clinical research regulatory affairs and data collection/abstraction
Experience with research administration
CONDITIONS OF EMPLOYMENT
The Division of Cardiology is located at the Health Sciences building on the University of Washington Medical Center Campus. Work is typically deadline driven and requires a high level of accuracy, extensive communication with scientists, staff and external collaborators from diverse backgrounds. Work week regularly exceeds 40 hours to complete projects or meet deadlines
Application Process: The application process for UW positions 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 Workforce 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 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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