Clin Research Finance Mgr, Sr

Pay Range Minimum
Job Code:

*This is an Exempt position. Employees in this position are paid a salary on a monthly basis and are not eligible to receive overtime pay.

JOB DESCRIPTION: This is a central university department job, reporting to the Office for Clinical Research (OCR). Responsible for budget development and negotiation for all industry and other non-federal studies with negotiable study budgets. Thoroughly reviews complex study protocols, Informed Consent Documents (ICD), draft sponsor Clinical Trial Agreements (CTA), and budgets to identify all Emory Healthcare (EHC) and/or Grady billable items and services required of the study which might generate a CPT code. Reviews and interprets the Prospective Reimbursement Analysis (PRA) to ensure all billable items and services needing to be billed to the grant are included on the PRA and in the study budget. Works collaboratively with the Principal Investigator (PI), Clinical Research Coordinator (CRC), and ancillary departments to identify all the costs associated with the research study. Assists the study team in determining how to operationalize the billable items and procedures. Utilizes the research fee schedule to develop the per patient and pass through budgets for those billable items and services which cannot be billed to third party payers. Works collaboratively with the study team and Emory research community to determine study team effort and research administrative costs. Negotiates the budget with the sponsor and/or Contract Research Organization (CRO) to cover all of Emory's costs to conduct the study. Communicates with the Emory University (EU) research administrative staff to route the study in EPEX, access documents from eIRB, and resolve pre-award study issues, as needed. Documents the CPT codes at the respective visits in the Emory Research Management System (ERMS) for all EHC billable items and services to be paid by the grant, and all study costs if invoicing done by OCR. Serves as the central resource for the research community to provide authoritative expertise and guidance on ERMS. Updates ERMS user manual as needed. Facilitates and manages activities associated with Emory-sponsored and investigator-initiated research studies. Responsibilities include, but are not limited to, the following functions regarding issues user accounts and resets passwords, determines if study registration is required per FDAAA or ICMJE guidelines, registers new studies in, tracks the initial registration process, ensures assignment of NCT number and posting to the public website, responds to QA review comments, addresses "problems, errors and/or warnings" within and facilitates their resolution, maintains current Emory records (ERMS, Rosetta), facilitates entry and maintenance of study updates and results, ensures study closure, and generates reports as needed. Works collaboratively and develops effective working relationships with Investigators and key study personnel to accomplish these goals. Ensures compliance with FDAAA, NIH, and ICMJE requirements for Emory-sponsored and investigator-initiated research studies. Serves as the central resource for the research community to provide authoritative expertise and guidance on regulations and requirements. May participate in cross-functional, multi-disciplinary OCR work teams based upon institutional and departmental priorities, and perform other pre and post-award responsibilities as needed. Functions independently and proactively with strong critical thinking, analytical, and communication skills. Effectively prioritizes tasks, and follows-up to ensure completion of studies in a compliant and timely manner. Meets departmental performance metrics. Effectively applies problem solving, negotiation, and continuous quality improvement methods in daily operations. Works collaboratively and professionally with OCR staff, the Emory research community, and external research customers such as pharmaceutical companies and Contract Research Organizations (CRO). Provides superior customer service to effectively meet the needs of internal and external customers. Demonstrates the characteristics of an effective team member. Actively participates in staff orientation, continuing education, and mentoring. Serves on OCR committees. Performs related responsibilities as required.
MINIMUM QUALIFICATIONS: Bachelor's degree in nursing, a healthcare or scientific field or other related field and five years of experience in research administration or a health-related field which includes three years of direct clinical research coordinator experience. An equivalent combination of education, training and experience will be considered for candidates without a bachelor"s degree. Strong project management, facilitative leadership and organization skills. Experience with budget development and negotiation with industry sponsors as well as highly desirable. Knowledge of Emory's ERMS, EPEX, and eIRB systems highly desirable. Proficient working knowledge of excel, access databases, and Microsoft office required. Strong knowledge of clinical processes, medical terminology, and the clinical research life cycle required. Certification in Healthcare Research Compliance through the Health Care Compliance Association is strongly preferred within five years of hire into this position.

The above statements are intended to describe the work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of the personnel so classified.


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