Position Summary:
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.
Job Responsibilities:
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 PeopleSoft 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
Minimum Qualifications:
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.
Preferred Qualifications:
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.