Description of Work:
Position Summary:
Working under general supervision, is responsible for ensuring the integrity of clinical financial data both in the clinical database as well as in the clinical files. Responsible for entering, reviewing, verifying and organizing incoming financial data.
Job Duties:
Clinical Study Payment (CSP) Processing:
Liaison with Accounting
Verifies accuracy of invoicing and other accounting documents or records
Enters data in computer system using defined computer programs (Oracle CSP and SAP)
Submits invoices to Accounts Payable for processing
Process facility service invoice for Letters of Agreement
Monitor study expenditures and terms of contract to ensure cost recovery and study specifications and timelines with study sites
Serve as primary contact for study site regarding reimbursement issues, project deliverables and budget allocation
Assigned as Reimbursement Lead on specific studies
Responsible for site contract budget set up in Clinical Study Payments Application for reimbursement
Serve as Peer Review for budget set ups
Special Payment Request:
Receive and Review site request for special procedure payments
Ensure that the proper approvals are in place for the requested services
Work with Clinical Operations Manager to negotiate rates for servies not contracted if needed
Issue Letter of Agreement for the sit if needed
Notify the site and study team of approval
Enter request in the FHP tracking tool
Patient Direct Reimbursement Processing:
Resolve any site/patient inquiries regarding payments
Provide reports to sites and study team upon request
Compliance tasks:
Perform data quality audits to ensure accuracy of HCP payments
Compile data and prepare a variety of reports
Review monthly accrual reports to make sure FHP payments have been resolved.
Requirements/Education:
High school diploma or other specialized training/equivalent related experience. Preferred Associate Degree in Accounting, Business Administration, or a related curriculum, plus experience in the biotech, bio-instruments or medical device industry.
Typically a minimum of two years of demonstrated experience as a Clinical Data Coordinator or in a comparable or closely related clinical research environment, including direct familiarity with data management processes.
Experience with the Food and Drug Administration (FDA), Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP) regulations as they apply to clinical data management and to the clinical trial process.
Demonstrated competence in English spelling, grammar and punctuation, including the ability to successfully pass a reading comprehension pre-employment examination.
Requires a demonstrated knowledge of the practices and procedures of the function, company products, policies and programs.
Demonstrated organizational skills, attentiveness to detail, ability to work under general supervision and the ability to handle multiple projects simultaneously.
Demonstrated interpersonal skills, including the ability to listen, resolve routine to moderately complex problems, deal with unresolved issues, delays and unexpected events, while effectively communicating and maintaining rapport with field clinical engineers and study coordinators.
Must possess demonstrated keyboard and personal computer skills (experience with Microsoft Office including Excel, Word or equivalent applications required), including the ability to pass a 10 key assessment examination.
St. Jude Medical is an Equal Opportunity Employer
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