"Clinical Trial Budget Analyst"

Advertising Summary

Virginia Commonwealth University (VCU) School of Medicine is a premier academic medical center located in the heart of Richmond. Accounting for almost half of VCU’s sponsored research, the School of Medicine is internationally recognized for patient care and education. Virginia Commonwealth University is an equal opportunity employer.

https://vcujobs.com/why-richmond

Unit

School Of Medicine MBU

Department

Dean's Office - Office of Clinical Research

Duties & Responsibilities

Seeking candidates with strong financial, analytical, and communication skills to join the School of Medicine (SOM) Office of Research Administration’s Clinical Research Office (CRO). Clinical research is a continually expanding area at VCU and in healthcare in general, and the CRO Budgeting team is committed to supporting VCU clinical researchers in advancing medical science in our region. Candidates’ clinical, analytic and financial skills can be applied in areas of coverage analysis and clinical trials budget development and negotiation. The selected candidate will be trained according to local and national standards and practices in developing clinical trial budgets. This position provides an opportunity to work in a fast-paced environment with potential for career growth in the field of Research Administration for those presenting a willingness to learn and ability to work collaboratively with a diverse group of faculty and staff.

This position is a key part of a team focused on supporting SOM clinical investigators with activation of clinical trials in a positive and dynamic environment. Working under supervision of Senior CRO Budgeting staff, key responsibilities this position will be trained to fulfill include:

• Working with principal investigators (PIs) on their investigator-initiated protocols by identifying all required costs and services needed for each study.
• Collaborating with the SOM Research Administration (SOMRA) team on proposals to ensure clinical trial budgets meet the proposal requirements.
• Conducting coverage analyses, develop and negotiate clinical trial budgets for all studies assigned. Ensure study billing grids are audit-ready and well interpreted by study teams.
• Working with sponsors of clinical research studies as well as SOM clinical researchers and study teams, and institutional offices to ensure efficient and effective financial implementation of SOM clinical studies.
• Actively participating in the development of best practice guidance and work aids for study teams in areas such as coverage analysis, pre-award finance, study activation, study coordination, data management, and records management.
• Providing support for maintaining and managing school level study activation processes; contributing to process improvement initiatives and other activities aimed at increasing efficiency.
• Serving as project lead in specific areas as assigned, e.g. project intake, coverage analysis, budget development.

Core Responsibilities

1. Responsibility 1 (10%): Accountability

Accountability, empowerment and excellence in customer service. Promote accountability by maintaining clear documentation of internal SOPs and working guidance, as well as providing clear communications to our customers. Understand the importance of ownership of tasks and responsibilities. Continue on the path to customer service excellence - continue to grow relationships with customers, develop trust, deliver on the services we are to provide. Seek feedback from all those with ideas and potential solutions to problems both internally and from our customers. Treat all those we encounter and work with respectfully and professionally. Support study administrative activation and amendment processes; facilitate various activities, e.g., intake, OnCore (clinical trial management system) build out, Division of Sponsored Programs (DSP) activity for contract review, interface with VCUHS (health system).

• Task 1: Develop and nurture relationships with PIs, all members of the study teams, departmental personnel, colleagues and co-workers throughout VCU and SOM, study sponsors.
• Task 2: Continually assess project priorities and timelines to ensure milestones for clinical research/trials in development are met.

2. Responsibility 2 (70%): Coverage analysis and budgeting

Perform tasks associated with coverage analysis and study budget development, including cross-training/ cross-coverage among coverage analysis and pre-award financial responsibilities for all types of studies.

• Task 1: Collaborate with PIs on their investigator initiated clinical research/trials by identifying services and other costs associated with protocol required assessments. Perform coverage analysis processes to ensure compliant clinical research billing. Review clinical trial materials and gain familiarity with respect to determining whether a trial meets the requirements to qualify for coverage, including documentation of qualification and desirable characteristics, where appropriate. Perform a detailed review of the clinical events in a protocol in order to determine the eligibility of each test, procedure or intervention for coverage. Engage in discussion with study team and other members of the CRO in order to develop proper billing grids to be utilized throughout study (with revision as necessary to align with protocol amendments). Coordinate the collection and electronic filing of all relevant components of the coverage analysis process to ensure consistent and reliable documentation for each study (audit-ready).
• Task 2: Maintain a key role in the development and improvement of standardized processes and ongoing education of research personnel. Ensure consistency with Center for Medicare & Medicaid Services (CMS), National Coverage Determination (NCD) for Routine Costs in Clinical Trials (310.1) and the Clinical Trial Policy (CTP).
• Task 3: Provide education related to research compliance, coverage analysis and budgetary standards to study teams as appropriate.
• Task 4: Develop, finalize and negotiate new study budgets for clinical trials in SOM for assigned projects, departments and divisions. Ensure all necessary VCUHS pricing is received for study related items, tests, and procedures. Support the acquisition of internal price quotes for ancillary services in a timely manner (e.g., pharmacy, radiology). Track for timeliness and consistency of pricing in order to ensure efficiency and standardization among studies. Facilitate study teams’ development of time/effort estimates for study activities. Develop budget components in accordance with University and SOM standards/
• Task 5: Proactively work with the SOMRA team to ensure alignment of trial costs with sponsor published guidelines. And to ensure proposal submission timelines are met.
• Task 6: Work with OnCore team and others as appropriate to improve study builds (e.g., calendar creation) and data collection methods to maximize efficiencies and clarity in documentation for hand-offs to post-award team. At or before study activation, participate where appropriate in a “hand-off” or in-service to post-award financial staff where appropriate and serve as a continuing resource to post award financial staff to answer queries related to study budget and/or contract terms related to financial management of the study.

3. Responsibility 3 (20%): Ongoing team support and continual improvement of processes

Provide ongoing support for clinical research operations and administration in SOM; ongoing communication with departments/divisions, study teams, administrators.

• Task 1: Actively participate in continual evaluation and improvement of clinical trial operations in CRO/SOMRA as well as with SOM departments/ divisions/centers. This includes evaluating processes and workflows for coordination and administration of clinical trials and making recommendations for improvement. Each member of the team is responsible for meeting departmental standards for activation of studies assigned to them, and for continually striving for improvement of processes and internal timelines/metrics. Each member of the CRO Budgeting team will serve as a SOM resource for defining school-level best practices and use of OnCore and other systems and tools within the SOM.
• Task 2: Each team member is also given ownership to lead efforts for development in key areas. Each team member’s niche is determined based on their strengths and the needs of the team. Examples include refinement of the new project intake process, Award system (SPOT) entry and interface with DSP, coverage analysis, budget development, team metrics and analytics, enhancements in formal updates to departments and divisions.
• Task 3: All team members recognize the importance of effective and efficient trial activation and management; they are responsible for supporting and implementing measures to collect data driven metrics, e.g., OnCore Task Lists and participation in developing or enhancing shared tools. Each member fully supports departmental needs to stay abreast of the status of clinical trials or clinical research projects under review for start-up or amendment processing. This includes the development, maintenance and continual improvement of departmental status updates, with expected enhancements to be determined, e.g., improved activation beyond CA and budget development, accrual reporting, financial tracking. Each team member fully embraces the supportive nature of the CRO Budgeting Team function within overall picture of clinical research at VCU and VCUHS.

Qualifications

Minimum Qualifications

• Bachelor’s degree in business management, finance, accounting or healthcare administration equivalent applicable combination of training, education and experience.
• Strong analytic, financial, organizational, time management and communication skills. Attention to detail is key. Ability to set priorities, make timely decisions and meet deadlines while working on multiple projects.
• Excellent customer service, verbal and written communication. Ability to work collaboratively and cooperatively in a large and complex organization and in a diverse and fast-paced work environment.
• Must be proficient in the use of computers and programs such as MS Office (e.g., Excel, Word) with an ability to learn new systems and software applications with ease.
• Demonstrated ability to work in and foster an environment of respect, professionalism and civility with a population of faculty, staff, and students from all backgrounds and experiences, or a commitment to do so as a staff member at VCU.

Preferred Qualifications

• Working knowledge of Medicare Clinical Trials Policy and other Federal, State and institutional clinical research regulations
• Experience working in Oncore or other CTMS systems
• Experience with clinical research protocols, developing and negotiating clinical trial budgets; creating/revising/implementing reports, tracking tools, professional documents; reading and interpreting complex contractual and budget terms
• Experience as a research study coordinator and/or fiscal specialist in a healthcare setting
• Understanding of federal proposal requirements and submission practices is a plus

Position will remain open until filled.

VCU is committed to hiring veterans! VCU will include a veteran's period(s) of military service in the calculation of their annual leave accrual rate. This may provide veterans with an increased leave accrual!

Salary Range

$65,000-$75,000

Benefits

All full-time university staff are eligible for VCU’s robust benefits package that includes comprehensive health benefits, paid annual and holiday leave granted up front, generous tuition benefits, retirement planning and savings options, tax-deferred annuity and cash match programs, employee discounts, well-being resources, abundant opportunities for career development and advancement, and more.

FLSA Exemption Status

Exempt

Restricted Position

No

ORP Eligible

No

Flexible Work Arrangement

Hybrid

University Job Title

3421B - Research Administrator Base