The College of Medicine, Department of Medicine is seeking qualified clinical research manager to supervise central clinical research team and serve as department point of contact for clinical research questions. This position reports to the Assoc. Director of Finance and works with Ast. Director of Rsch Admin in supporting our faculty with industry and federally funded studies. Key responsibilities include training/on-boarding clinical coordinators in managing all aspects of the study (budget, cost of services, billing, enrollment, patient visits, closeout, etc.), carrying small portfolio of studies with patient visits, ensuring regulatory compliance for studies in the department and work with sponsors/core office on terms of clinical trial agreements.
Clinical Trial Management
The incumbent will work closely with our Clinical Research Coordinators, Office of Clinical Research and Research Admin team in assisting clinical trial budget negotiation with industry sponsors
Works collaboratively with the Principal Investigator (PI), Clinical Research Coordinator (CRC), and ancillary departments to identify all the costs associated with the research
Utilizes the research fee schedule and standardized price list in the development of study billing plans
Negotiate payment terms of the Clinical Trial Agreement (CTA) with sponsor
Prepare financial analysis for proposed clinical trials to ensure financial viability of study based on enrollment projections
Assistant with the execution of confidentiality agreements (CDA) and CTAs in UFIRST
Prepare OCR Intake Form and related documents, and submit study package to OCR
Functions independently and proactively with strong critical thinking, analytical, and communication skills.
Maintains accurate accounts receivable and payable data
Manage study finances including sponsor invoicing & resolving study subject billing issues
Reconcile study payments via the university’s clinical research system
Prepare monthly reports outlining financial status of studies, enrollment target, etc.
Facilitate timely reconciliation and close-out of terminated clinical trial accounts
Maintains, oversee, reconcile, and corrects errors in accounts. Processes clinical research and core bills for payment
Work with PI and Clinical Research Coordinator on budgetary amendment implementation
Assist with clinical trial study financial closeout and residual balance transfers
Training and Supervision
Meet weekly with staff to review open studies, assign new requests for support or training, answer questions, discuss training opportunities/best practices
Ensure team compliance with regards to study management, fiscal and regulatory requirements
Act as liaison for the department meeting as needed with faculty and program directors, Office of Clinical Research, IRB and IACUC offices
Establish and maintain standard on-boarding documents and checklist for clinical trial coordinators hired into the department
Train and Onboard clinical coordinators on central team and as requested by department teams.
Identify and support needs of existing clinical trial teams needing temporary support or specific regulatory/billing needs.
Other duties as assigned