Ampcus, Inc
Public Administration Analyst - Clinical Research
Ampcus, Inc, Chantilly, Virginia, United States, 22021
Remote. Required: 1 or more years of experience in budget negotiations in clinical research. Demonstrated working knowledge of current medical terminology specific to oncology.
Oversee, manage and participate in the budgetary amendment research activities as part of the Clinical Research Unit while under the direction of Financial Administrative Officer (FAO), Faculty Director, Medical Director, and Research Directors (Senior Management) of the JCCC CRU. The incumbent is responsible for the oversight of execution of budgetary amendments on active clinical trials. This includes responsibility for coordination of submissions to contracting and the CRU Oncore build team to update study calendars and budgets so that they may reflect the current IRB approved protocol. Work with Industry partners to process, review and execute budget and contract amendments in a timely manner. Ability to work flexible hours and/or overtime to meet study deadlines and requirements. Work may be assigned by Senior Management, and assignments may be changed on an as-needed basis in order to ensure that studies and patient care needs are handled appropriately and in a timely manner.
TYPE OF SUPERVISION RECEIVEDThe incumbent is expected to independently prioritize assignments and complete ongoing tasks following established Clinical Research Unit procedures and regulatory guidelines. Incumbent will seek guidance from direct supervisor or Assistant Director when there are conflicting demands. In addition, the reporting structure of this position may require the incumbent to report on matters to CRU administrative staff who may not be members of the home department for this position. Time reporting, requests for vacation and other similar matters will be addressed with the direct supervisor or Assistant Director. A work performance evaluation will be undertaken on an annual basis.
DUTIES AND TASKSClinical Research Budget and Contract Management for Active Clinical Research StudiesAct as the primary liaison between Principal Investigator, Senior Management, study team, sponsor, UCLA Investigational Drug Services (IDS) Pharmacy, and appropriate departments (Laboratory, Radiology, Pathology, Cardiology, CTRC, etc.) in discussion of budgetary and contractual amendments.With input from the Principal Investigator and study team, prepare and complete the appropriate submission to initiate budget/contract amendments for execution.Sponsor, prepare budget for review and complete negotiations.Ancillaries (CTRC, pharmacy, radiology, JSEI, etc.): update any applications when services change due to budgetary/contractual amendments.Coverage Analysis: Prepare and submit amended budget to the Hem/Onc Budget Committee. Attend the scheduled review of the budget and assist in resolving any queries that result with Sponsor or PI to ensure the budget is released for negotiations. Once budget has been released, negotiate the budget with Sponsor representative in a timely manner. Working with PI to escalate any concerns about negotiation to the Sponsor. Coordinating with coverage analysis for final certification once negotiations are complete.CT&SR: Prepare and submit internal UCLA financial documents in a timely manner to ensure that contract can be executed upon finalization of the budget.Prepare and maintain study-specific financial files with all appropriate study-specific documentation.Notify the study team when updated calendars have been released and can be utilized.Coordinate timing of budget negotiations with IRB submission and Beacon build updates so that calendars are ready for utilization when other approvals are in place.General Research Responsibilities and Special Projects Clinical Research UnitAttend monthly CRU staff meeting.Attend off-campus study and/or research meetings as required.Work flexible hours and/or overtime to meet study deadlines and requirements.Work on additional special projects may be assigned by Principal Investigator, CRU Research Director on an as-needed basis.
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Oversee, manage and participate in the budgetary amendment research activities as part of the Clinical Research Unit while under the direction of Financial Administrative Officer (FAO), Faculty Director, Medical Director, and Research Directors (Senior Management) of the JCCC CRU. The incumbent is responsible for the oversight of execution of budgetary amendments on active clinical trials. This includes responsibility for coordination of submissions to contracting and the CRU Oncore build team to update study calendars and budgets so that they may reflect the current IRB approved protocol. Work with Industry partners to process, review and execute budget and contract amendments in a timely manner. Ability to work flexible hours and/or overtime to meet study deadlines and requirements. Work may be assigned by Senior Management, and assignments may be changed on an as-needed basis in order to ensure that studies and patient care needs are handled appropriately and in a timely manner.
TYPE OF SUPERVISION RECEIVEDThe incumbent is expected to independently prioritize assignments and complete ongoing tasks following established Clinical Research Unit procedures and regulatory guidelines. Incumbent will seek guidance from direct supervisor or Assistant Director when there are conflicting demands. In addition, the reporting structure of this position may require the incumbent to report on matters to CRU administrative staff who may not be members of the home department for this position. Time reporting, requests for vacation and other similar matters will be addressed with the direct supervisor or Assistant Director. A work performance evaluation will be undertaken on an annual basis.
DUTIES AND TASKSClinical Research Budget and Contract Management for Active Clinical Research StudiesAct as the primary liaison between Principal Investigator, Senior Management, study team, sponsor, UCLA Investigational Drug Services (IDS) Pharmacy, and appropriate departments (Laboratory, Radiology, Pathology, Cardiology, CTRC, etc.) in discussion of budgetary and contractual amendments.With input from the Principal Investigator and study team, prepare and complete the appropriate submission to initiate budget/contract amendments for execution.Sponsor, prepare budget for review and complete negotiations.Ancillaries (CTRC, pharmacy, radiology, JSEI, etc.): update any applications when services change due to budgetary/contractual amendments.Coverage Analysis: Prepare and submit amended budget to the Hem/Onc Budget Committee. Attend the scheduled review of the budget and assist in resolving any queries that result with Sponsor or PI to ensure the budget is released for negotiations. Once budget has been released, negotiate the budget with Sponsor representative in a timely manner. Working with PI to escalate any concerns about negotiation to the Sponsor. Coordinating with coverage analysis for final certification once negotiations are complete.CT&SR: Prepare and submit internal UCLA financial documents in a timely manner to ensure that contract can be executed upon finalization of the budget.Prepare and maintain study-specific financial files with all appropriate study-specific documentation.Notify the study team when updated calendars have been released and can be utilized.Coordinate timing of budget negotiations with IRB submission and Beacon build updates so that calendars are ready for utilization when other approvals are in place.General Research Responsibilities and Special Projects Clinical Research UnitAttend monthly CRU staff meeting.Attend off-campus study and/or research meetings as required.Work flexible hours and/or overtime to meet study deadlines and requirements.Work on additional special projects may be assigned by Principal Investigator, CRU Research Director on an as-needed basis.
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