Clinical Research Administration (CRA) provides centralized services and oversight functions for coordinating, facilitating and reporting on clinical research by assisting Investigators and research staff with developing protocols and submitting grants. These services include providing staff with efficient protocol preparation, revision, activation, including a focus on collaborative activity. Since there are many elements unique to managing clinical research funding, it is essential to develop a Clinical Research Financial Administration Core with a thorough understanding of all key components in the financial life cycle of clinical research studies and use key tools including CTMS and EPIC for successful planning and managing the finances.
Reporting directly into the Executive Director, the Clinical Research Finance Administrator will manage the day to day operations of the core’s centralized support services related to pre-award and post-award management and relevant regulatory operations. Working closely with Research Leadership to collectively carry out the strategic objectives for research across HSS, this individual will collaborate with the other HSS administrative offices including Legal, Corporate Compliance, Insurance/Risk Management, Finance, Physician Services, Patient Accounting, etc.
The individual will provide management of the Clinical Research Program Managers that includes financial, operational, regulatory, and personnel activities as well as serves as administrative liaison to 15+ services lines in Surgery, Medicine (e.g. Rheumatology and Neurology) and Ancillary Services (e.g. Pathology, Radiology, Rehabilitation and Anesthesia). This support will include financial guidance for both translational and clinical research by providing comprehensive assistance to Investigators and research personnel at the HSS and its affiliates. In addition, ensuring compliance with all state and federal regulations pertaining to research funding is an essential responsibility of this position.
The individual will assist the Contracts Administrator with reviewing payment milestones of clinical trial agreements (CTAs) and contracts and provide assistance and oversight to the service lines with budget preparations and billing compliance. He/she will interact and communicate with Industry Sponsors, Device Manufacturer, Clinical Research Organizations (CROs) and other external entities on behalf of the Research Institution Scientists, Service Line Clinicians and Surgeons and research personnel on complex issues related to externally funded clinical research.
Importance of Role:
- Develop and implement process improvement and standard practices surrounding budget review, development, and negotiation; clinical research billing review and payment milestone; evaluation, tracking, and management of clinical trial earnings and expenses; sponsor invoicing; and timely collection.
- Assist with the facilitation of timely execution of agreements and sub-contracts.
- Establish professional relationships with pharmaceutical, device manufacturer, CRO, and non-profit counterparts to facilitate amicable and timely negotiations.
- Ensure that the hospital is maximizing its revenue both from the funder of clinical trials and to advance Service Line’s efficiency and profitability.
Daily Responsibilities Include:
- Manages pre-award and post-award activities for a complex portfolio of clinical research studies within Clinical Research Administration (CRA) using knowledge of federal grants, corporate contracts, and clinical trial management rules and regulations including coverage analysis (CMS), technical expertise, and analytical skills.
- Read and interpret clinical trial study documents including Protocol, Budget, Contract, Informed Consent, and Laboratory Manual.
- Responsible for assisting Service Line Research Managers and CRA’s Program Managers with the development of research budgets with external corporate sponsors to assure research costs are appropriately negotiated.
- In collaboration with Sponsored Programs, assists with the development of budgets for investigator initiated projects and translational projects with clinical care costs in collaboration with Investigators and/or Scientists.
- Interacts regularly with and provides high quality customer service to investigators, research assistants, and service line managers conducting sponsored research/clinical trials.
- Works with ancillary service lines (e.g. radiology; clinical labs, pharmacy etc.) to develop charge master with fee schedules for clinical care related to research.
- In collaboration with Research Accounting, contributes information and ideas related to areas of responsibility as part of a cross functional team by establishing a business process for invoicing and the collection of revenues based on the executed clinical research agreement to assure standardization of research and billing compliance initiatives.
- Daily interactions with Post Award Administration and Research Accounting to help develop opportunities to prevent clinical research deficits by receiving expenditures including monitoring personnel time/effort (via PCFs).
- Assurance that QCTs are identified and set up as such in ECAP and Epic.
- In collaboration with the Clinical Trials (EPIC) Administrator, assurance that billing is reviewed and performed in compliance with applicable regulations and payor requirements.
- In collaboration with Research Accounting assists in the resolution of denials in conjunction with Revenue Cycle personnel in Finance department.
- Assure protocol amendments are reviewed by IRB, Contracts Administrator and budget is reviewed by applicable Program Managers.
- Reviews budgets for consistency with sponsor protocols and monitors compliance with funding agency and HSS regulations regarding submission and financial progress reporting.
- Assist with the implementation of Clinical Trials Management System and provide guidance and oversight to the CTMS Program Manager.
- Provide metrics and other reports when applicable.
- Assists with the development of policies and procedures (SOPs) and training/education initiatives within the Quality Assurance Program related to research billing compliance.
- Other special projects as necessary including presentations to leadership, chairing and/or co-chairing relevant meetings, participate in hospital and research committees; produce various metrics report to improve operations, retreats, etc.