Under the general direction of the Manager of Clinical Trials Financial Operations, the Clinical Trials Budget Analyst II will have primary responsibility for managing the daily business and financial activities of Clinical Trials assigned to them. This position is responsible for the planning, implementation and post implementation phases of various types of Clinical Trials. The Clinical Trials Budget Analyst II, under the direction of the Manager of Clinical Trials Financial Operations, will determine the appropriate qualitative and quantitative measures to evaluate progress, successful implementation and completion of assigned Clinical Trials. The Clinical Trials Budget Analyst II will provide regular progress reports to their manager and other groups as appropriate. This role requires initiative, independent judgment and discretion.
Required Minimum Knowledge, Skills, and Abilities (KSAs)
- Bachelor’s Degree in a related field or 3 years’ experience as a Clinical Trials Budget Analyst. Master’s Degree preferred.
- A minimum of 3-5 years of work experience with clinical trials, or a combination of clinical trials and relevant work experience required
- Must have working knowledge of clinical trials via 1-2 years of industry or site experience
- Must understand what is standard of care or routine care and what is considered research-related in the context of a clinical trial
- Excellent organizational skills, ability to prioritize work independently with strong attention to detail and superior analytical and problem-solving skills
- Ability to work in collaboration with ancillary teams, departments, investigators, research staff, supporting administration, and sponsors/funding agencies.
- Provide excellent customer service while maintaining accurate results in a fast-paced, deadline-driven team environment.
- A minimum of 2-3 years direct experience budgeting and estimating clinical trials costs
Clinical Trials Management
- Review study protocols for financial and resource feasibility. Carry out periodic reviews of study files to ensure administrative quality, compliance, and consistency across clinical trials.
- Create and review Clinical Trial study budgets to ensure these budgets are developed in accordance with approved systems, tools and standards.
- Manage the process of the Clinical Trial lifecycle to ensure that accounting activities, such as tracking participant/study milestones, reconciling accounts, processing and approving study bills, invoicing sponsors, and reviewing account status with Principal Investigators.
- Monitor status of protocol or trials under development and facilitate timely coverage analysis, contracts, and budget proposals with external vendors
- Support the development of the overall study budget with functional inputs.
- Act as liaison between the study team and the vendor to resolve any questions regarding the schedule of events.
- Review protocol amendments for any revisions affecting the budget; update budget as necessary. Ensure amendments affecting the MCA or Agreements are processed in a timely and coordinated manner.
- Work independently and collaboratively on special projects and initiatives as assigned.
- Monitor study progress and flag milestones for Accounting to send invoices to sponsors or to transfer funds to other departments.
- Review Charges to ensure billing to study accounts is done in accordance with the study budge and MCA.
- Work with sites to resolve any budget questions and standard of care disputes to ensure resolution of budget and billing queries in a timely manner.
- Coordinate with the Institutional Review Board, Contracts, Grants, Medicare Coverage Analysts, and other internal / external parties to ensure that all required approvals are received prior to study initiation.
- Work collaboratively with Clinical Trials Sponsors to build and/or revise budgets for Clinical Trials
- Work collaboratively with the Clinical Trial Financial Operations Team to streamline processes and provide backup for teammates.
- Prepare reports to assist in determining feasibility and cost-effectiveness of a Clinical Trial.
- Work with Investigators and Study Teams to advise on feasibility and cost-effectiveness of their Clinical Trials
- Establish resource meetings with study teams and billing to review study logistics, the Medicare Coverage Analysis (MCA), budget, other study documents, and to make conventional care determinations to complete the final draft of the MCA.
- Facilitates billing compliance using the Medicare Coverage Analysis
- Entry and maintenance of research studies in the electronic medical record and other related systems
- CTMS Management and support
- In coordination with Lead Clinical Trial Budget Analyst and Manager Clinical Trial Business Operations- maintain tracking systems for all clinical trial awards and milestone deliverables throughout their lifecycle.
Maine Medical Center is a Magnet designated 606-bed tertiary care and teaching institution. MMC is Maine’s largest hospital and a state-wide health care resource. MMC offers outstanding career opportunities and quality of life in Portland.