University of Rochester Clinical Research Specialist, Surgery Research - 231520 in Rochester, New York
Clinical Research Specialist, Surgery Research Job ID 231520Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening
Full Time 40 hours Grade 051 Surgery ResearchSchedule
8:30 AM-5 PMResponsibilities
With minimal direction and considerable use of independent judgment, the Clinical Research Specialist will utilize financial concepts, communication skills, and experience/knowledge of the clinical research enterprise to navigate clinical research services in collaboration with Surgery faculty and staff. This position combines working knowledge of clinical research and finance to advance clinical research work in the Department of Surgery. The individual in this position will work closely with the Research Program Manager and the Senior Research Accountant to develop and implement infrastructure and support clinical research within the department. The Clinical Research Specialist will also engage with faculty and act as a liaison with the Office of Clinical Research to develop both industry and investigator-initiated trials by providing support with creating budgets, calendars, and negotiating with sponsors plus other pre-award and post-award activities as needed. This position will also support study personnel and the Senior Research Accountant with the collection and management of clinical research revenue and expenses. This position requires excellent communication and organizational skills, and solid foundational, financial, and operational knowledge in clinical research.
Financial Oversight, Invoicing, and Reconciliation, 40%
Supports the department and provides guidance with (a) invoicing the sponsor, reconciliation of payments received, and assuring proper application of this data into the CTMS and (b) reconciling the study financial information in the CTMS to the study’s WorkDay (financial) account.
Provides guidance to department on managing invoices and assuring appropriate follow up on accounts.
Performs budget-to-actual analyses and financial projections in collaboration with Senior Research Accountant
Communicates directly with investigators and department leaders about study budgets, study financial positions, and budget projections. Keeps all parties apprised of issues related to specific study finances or related to research finance at large.
Budget Development and Study Activation, 30%
Develops and seeks Principal Investigator approval for CTMS coverage analysis.
Coordinates activities with the Office of Clinical Research to develops cost and time analysis for studies using established processes and in conjunction with investigators, department heads, and other stakeholders, and acquires all necessary approvals.
Serves as liaison between department study personnel and ORPA to submit clinical research
Works with Office of Clinical Research and Study Personnel to validate the CTMS calendar and provide support with importing the calendar into the OnCore system.
Works with Office of Clinical Research and study personnel to ensure any clinical research study with billing risk has a Billing Grid in the Clinical Trials Management System (CTMS) and a unique study record in eRecord
Support for Industry and Investigator Initiated Trials, 20%
Works with faculty and study personnel to assist with navigation of UR systems including OnCore (CTMS), Forte participant payment portal, EPIC medical records, and Workday financial system to initiate clinical research including trials
Assists with protocol development using available tools and templates
Liaises with Clinical Research Office at Wilmot as needed for cancer trials
Works with study personnel to coordinate collection of regulatory documents as needed for trial activation
Builds and maintains inter-departmental and stakeholder relationships.
Other projects and job duties as assigned.
Bachelor's degree, required.
1 year of experience in human subject research coordination or equivalent combination of education and experience is required. Major course work in a related health, science, or technical field is preferred.
Proficiency in Microsoft Outlook, Excel, Word, PowerPoint, eRecord, and database experience.
Must be familiar with clinical research budget development and negotiations.
Proven ability to interact with all levels of faculty and staff in a professional manner.
CLASP certification preferred. Candidates who do not currently possess this certification will be required to attend classes upon hiring and successfully obtain and maintain certification.
2-4 years of experience in an academic setting.
Excellent interpersonal, presentation, analytical, and communication skills focused on customer service.
Attention to detail and ability to show initiative and resourcefulness in managing priorities.
High level of accountability for accomplishing one’s own work.
Ability to work collaboratively and maintain confidentiality of information at all times.
Proven writing skills highly desirable.
How To Apply
All applicants must apply online.
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University of Rochester
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