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Clinical Trials Business Operations - Associate (FT), Clinical Trials Office - Days

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Professional/Management
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180001ZL Requisition #
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This would be a good position for a Project Manager with Finance experience who is looking for a more Challenging role. 
 
 
JOB SUMMARY:
Reports to the Manager, Clinical Trial Business Operations. Primary duties include assisting with the completion of various tasks related to the initiation and administrative management of clinical trials.
 
These tasks include:
1) Development of Medicare Coverage Analyses (MCAs) for all clinical trials.
2) Maintenance of the Dartmouth study and patient registry including related document management.
3) Assisting research teams with the preparation of budgets for all studies.
4) Supporting study feasibility assessments and participating in resource meetings.
5) Ensuring all required internal and external approvals have been granted prior to initiating the study.
6) Reviewing patient care bills for consistency with the MCA.
7) Other related study management activities as instructed by the CTBO Manager.
 
JOB RESPONSIBILITIES:
1. Medicare Coverage Analysis and Related Support:
Perform Medicare Coverage Analyses as appropriate for all studies, including entering the appropriate HCPCS and CDM codes for items and services to complete the Billing Grid and determining if conventional care items/services qualify for Medicare coverage.
 
2. Clinical Trials Registry and Other Document Management:
Coordinate with Research Teams to validate the study and patient data in the Registry and to ensure data is consistent with the Dartmouth Billing System and the IRB Database. Manage receipt of and upload all appropriate study related documents.
 
3. Budgeting Oversight:
Review (or, as requested, assist research teams with the development and negotiation of) clinical trial study budgets to ensure these budgets are developed in accordance with Dartmouth approved information systems, tools and standards.
 
4. Study Feasibility and Resource Meetings:
Participate in resource meetings with study teams to review the MCA, budget, other study documents, and to make conventional care determinations to complete the final draft of the MCA.
 
5. Study Approvals:
Act as the main study liaison for the CTO and coordinate with the IRB and other internal / external parties to ensure that all required approvals are received prior to study initiation.
 
6. Bill Review:
Make determinations on the segregation of items and services provided to research patients with the use of a Medicare Coverage Analysis billing grid and other medical documentation and ensure either the patient or the research account was billed appropriately for clinical trial related item and services.
 
7. Study Management:
Perform various study accounting activities, such as tracking patient/study milestones, reconciling accounts, processing and approving study bills, invoicing sponsors, and reviewing account status with PIs.
 
 
Additional Responsibilities:
1. Actively participate in study resource meetings and act as the primary CTO liaison to PI and research staff.
2. Participate in the development of and make periodic updates to Clinical Trials Business Operations policies and procedures.
3. Maintain a working knowledge of medical coding principles, governmental regulations, protocols, and third party requirements regarding clinical research billing and documentation.
4. Attend regular internal training and education.
5. Train or assist in training new Clinical Trial Business Office Associates to ensure uniformity and quality of work.
6. Maintain confidentiality in all aspects of communication.
7. Perform other duties as required or assigned by the CTBO Manager.
MINIMUM EDUCATION & EXPERIENCE:
  • Bachelor’s degree with a minimum of 2 years of experience in a healthcare or clinical setting with demonstrated knowledge of clinical trial billing compliance and pre-award activities required.
  • Knowledge of coding encouraged.
  • Strong competency in Microsoft Excel and Word required.
  • Knowledge of Velos preferred.
  • Effective organizational skills with strong attention to detail.
  • Effective interpersonal and communication skills desired.

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