CTO Research Finance, Pre-Award Specialist, Massey

Massey Comprehensive Cancer Center Mission

"To improve the lives of all Virginians by delivering cutting-edge cancer care through patient-centered prevention and treatment; high-impact, innovative research; community input and engagement; and education and training of the next generation of researchers and healthcare professionals.

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!

Job Summary

Administrators provide administrative management of one or more functional units, departments, auxiliary functions, or business units. They are typically responsible for overseeing and coordinating all administrative affairs, with strategic management of daily operations as a primary purpose. The role may have direct and indirect reports. Administrators typically serve as liaisons between internal departments or functional areas in order to achieve operational goals. They serve as resources to lower-level staff. Their decision-making has a significant impact on service delivery and student success. Administrators work under intermittent supervision, resolving complex issues independently and referring unprecedented issues to a higher level. They typically report to executive or senior leadership. NOTE: The primary purpose of the administrator job is the strategic management of daily operations and not primarily supervision, although the role may have direct and indirect reports.

The CTO Research Finance Pre-Award Specialist works directly with the Pre-Award Manager to support pre-award activities for research studies in relation to calendar builds, Medicare coverage analysis (MCA or CA) creations as well as budgets, grants, and contracts for clinical trials.

This position is eligible for flexible work arrangements.

Job description

• Responsible for creating and updating Clinical Trials Management System (CTMS) - OnCore Study Calendars grids in accordance with protocol schedule of events, local and national treatment guidelines

• Responsible for development, design and implementation of the Clinical Trials Management System (CTMS) Calendar specifications to describe clinical research protocol schedules in accordance with study protocol schedule of events and internal guidance for items needed for billing purposes

• Responsible for maintaining and updating all active protocol calendars and CAs for trials at MCC. This includes all protocol, budget, and contract amendments.

• Responsible for creating MCA grids in accordance with protocol schedule of events, local and national treatment guidelines

• Performs detailed review of protocols, budgets, informed consent forms, contracts, Notices of Grant Award (NOGA), FDA letters, and other relevant research documents to determine qualifying status and conduct a comprehensive MCA

• Consults Investigators to support billing coverage determinations

• Collaborates with other pre-award staff, VCU Health Office of Clinical Research, and the research study team to finalize the MCA report and billing grid and the cost estimates for each trial

• Maintains metrics regarding time to build and time to receive feedback from ancillary departments to identify any bottle necks

• Work collaboratively with clinical research administration to develop schedule of events to track patient care expense and sponsor payments

• Develops standardized budget templates and study team effort estimates for all clinical trials.

• Collaborates with clinical teams to ensure budgeted study items are congruent with the protocol, coverage analysis, contract, and informed consent.

• Responsible for negotiating clinical trial budgets with external sponsors to ensure all study costs are fully funded by sponsors.

• Collects and obtains appropriate approvals/signatures for internal budgetary documentation for all clinical trials and creates/finalizes the proposal submission in RAMS-SPOT for institutional review and approvals.

• Maintains budget and contract review status changes, in real time, in the Clinical Trial Management System (CTMS).

• Ensures all fully executed/approved budgets, correspondence, service agreements, and other essential documents are loaded into the CTMS and shared drive.

• Builds the finalized budgets into CTMS for post award management of externally funded studies.

• Completes an advanced index request for all assigned budgets and ensure new indexes are distributed to the post award team and saved on the shared drive.

• Manages, monitors, and maintains compliance for all aspects of clinical trial budgets throughout the life cycle of a clinical trial.

• Assists in the development and submission of requests for post-award modifications, such as re-budgeting and no cost extensions.

• Reviews protocol amendments to verify if they impact the calendar, coverage analysis, budget or contract, and initiates any necessary changes.

• Demonstrated ability to work with detailed financial data and to analyze financial information.

• Other job duties as assigned