• Finance Administrator, Clinical Research

    Location US-NY-New York
    Posted Date 2 weeks ago(11/27/2019 12:12 PM)
    Job ID
    2019-12241
    Category
    Finance
    Emp Status
    Regular Full-Time
    Hours per Week
    35
    Shift
    Days
  • Overview

    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.

    Qualifications

    MINIMUM QUALIFICATIONS

    • Nursing, Medical or Master’s Degree preferred in Life Sciences
    • Must have 5+ years of clinical trials management/leadership experience including investigator initiated protocol development
    • Must have finance experience in externally funded phase I to phase IV clinical trials
    • Must have prior training in QCT determination and Medicare Coverage Analysis to be able to train Program Managers and Research Accounting Analysts
    • Strong clinical background necessary to read and understand complex intervention protocols that include investigational drug and/or device.
    • Clinical Trials Management System implementation and management recommended
    • Thorough understanding of research administration guidelines of Federal and non-Federal sponsors supporting research and educational activities, preferably in an academic environment.
    • Thorough knowledge of applicable regulatory and compliance requirements related to use of human subjects in research, financial conflict of interest, IRB, etc.
    • Proven ability to analyze complex financial issues, recognize potential impact, identify creative and alternative solutions; make and implement recommendations. Demonstrated problem-solving and negotiation skills with ability to exercise discretion.
    • Experience analyzing expenditures, recognizing trends in order to support budget adjustments.
    • Proven ability to assess and contribute to development of automated systems to facilitate award administration. Demonstrated skill in setting up and maintaining accurate filing systems.
    • Experience in developing, producing and completing complex reports for various funding agencies, projecting multi-year expenditures and outcomes as they relate to individual projects, and the department as a whole. Experience applying programmatic knowledge to coordinate financial aspects of award administration.
    • Ability to maintain a professional attitude during interaction and collaboration with a wide range of personalities. Excellent communication skills

    Minimum Computer Skills

    • Microsoft Word
    • Power-point
    • Excel – Intermediate
    • Microsoft Outlook
    • EPIC EMR and CTMS experience necessary
    • Lawson’s grant management a plus

    General Skills

    • Excellent written, oral presentation and interpersonal skills
    • Demonstrated knowledge of clinical trials including regulatory including billing compliance experience (QCT/MCA)
    • Proven ability to provide scientific and clinical expertise in all phases of clinical trials
    • Excellent analytical and problem solving skills Independent thinking and planning ability;
    • Excellent written and verbal communication skills a must; and
    • Good teamwork skills, as well as the ability to work independently

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