Clinical Research Operations Specialist - Clinical Trial Budgets

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We have an exciting opportunity to join our team as a Clinical Research Operations Specialist.

This position will serve as the primary point of contact for investigators and study teams within an assigned portfolio for clinical trial budgets.

• Using the internal billing grid/prospective reimbursement analysis, develops a complete internal budge assuring that all research procedure, subject, personnel and administrative fees are accounted for.
• Applied appropriate inflation and margin rates Perform other duties as assigned
• Reviews study amendments for impact to budget and contract and initiates those processes when necessary
• Maintains transparency with study teams as to status of budget
• Serves as the primary liaison between the department/investigator and central office on all matters of study preaward budget processes Releases the study for activation when central office processes are complete and budget and contract are final
• Collaborates with Research Finance to load an appropriate budget into People Soft and create the chart string Enters finalized sponsor invoicing terms and entered into Clinical Research Management system, including appropriate visit descriptions and payments, invoiced separately procedures, optional procedures, subject stipend and travel terms and other reimbursable items.
• Collaborates with sponsored projects staff to ensure final negotiated budget and billing terms are incorporated into executed clinical trial agreement
• Compares completed internal budget against sponsor offer and negotiates with sponsor until a satisfactory reimbursement schedule is obtained

A Bachelors degree in accounting, finance or healthcare related field required

Five or more years experience developing and negotiating budgets.

Prior experience in clinical research and/or in research billing compliance required

A working understanding of research billing compliance including National Coverage Determinations (NCCDs) for coverage of routine costs and the CMS Clinical Research Policy required

Analytical, mathematical, and accounting skills to produce accurate data and/or recommendations.

Demonstrated advanced knowledge and expertise in the use of Excel.

Excellent communication skills (oral, written, and interpersonal) to effectively interpret instructions, convery and present information and interact with a wide variety of people in a helpful, effective, and informative manner using tact and diplomacy.

Prior experience as a study coordinator is highly desirable Knowledge of pre-and-post award grant management desired

Prior experience with oncology clinical trials desired

Qualified candidates must be able to effectively communicate with all levels of the organization.

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