Emory University Sr. Clinical Research Finance Manager in atlanta, Georgia
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 ClinicalTrials.gov activities associated with Emory-sponsored and investigator-initiated research studies.
Responsibilities include, but are not limited to, the following functions regarding ClinicalTrials.gov: issues user accounts and resets passwords, determines if study registration is required per FDAAA or ICMJE guidelines, registers new studies in ClinicalTrials.gov, 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 ClinicalTrials.gov 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 ClinicalTrials.gov 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 ClinicalTrials.gov 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.
Bachelor's degree in nursing, a healthcare or scientific field or other related field and 5 years of experience in research administration or a health-related field which includes 3 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 ClinicalTrials.gov 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.
Degree in finance/healthcare.
Master's degree preferred.
Completion of EHC Quality Academy, EBI, RAE, Train the Trainer, and/or Mentor Program at Emory a plus.
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Job Number 26744
Job Type Regular Full-Time
Division Exec.V.P. for Health Affairs
Department Office for Clinical Research
This position may involve the following Health and Safety issues: Not Applicable
Job Category Research & Research Administration
Emory University is an equal opportunity/equal access/affirmative action employer fully committed to achieving a diverse workforce and complies with all applicable Federal and Georgia State laws, regulations, and executive orders regarding nondiscrimination and affirmative action in its programs and activities. Emory University does not discriminate on the basis of race, color, religion, ethnic or national origin, gender, genetic information, age, disability, sexual orientation, gender identity, gender expression, and veteran's status. Inquiries about this statement should be directed to the Office of Equity and Inclusion, 201 Dowman Drive, Administration Bldg, Atlanta, GA 30322