Lead Clinical Trials Research Manager - Atlanta, United States - Emory Healthcare/Emory University

Description

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Description

JOB DESCRIPTION:

• This is a central job, reporting to the Office for Clinical Research (OCR). Responsible for the Prospective Reimbursement Analysis (PRA) for all studies with EHC and/or Grady billable items and services.
• Also, 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 the Emory Healthcare (EHC) and/or Grady billable items and services required of the study which might generate a CPT code.
• Applies the Centers for Medicare & Medicaid National Coverage Determination (NCD) 310.1, Routine Costs in Clinical Trials, to determine if the study is a qualifying clinical trial with therapeutic intent, diagnosed disease, Medicare benefit category, and deemed status or seven desirable characteristics.
• Determines deemed status by researching if the study is federally funded and has an Investigational New Drug Application (IND).
• Verifies the IND status in the study protocol, eIRB, or FDA study documentation.
• Evaluates Category A and Category B devices to determine which devices can be billed to Medicare.
• Utilizes the Medicare National Coverage Determinations, Medicare Contractor Local Coverage Determinations, Physician Association Practice Guidelines and Best Practices, Disease Organization Guidelines and Best Practices, certain Medicare and Medicaid approved compendia listings, peer reviewed medical journal articles, and other federal and state regulations to determine which EHC and/or Grady billable items and services in the sponsor's protocol may and may not be billed to Medicare and other third party payers.
• Customizes the PRA for pediatric clinical research studies, utilizing Medicaid, Georgia statutes, and/or other reliable sources.
• Works collaboratively with the Principal Investigator (PI), Clinical Research Coordinator (CRC), and ancillary departments to identify all the costs associated with the research study.
• 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 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 the study costs if centralized invoicing is done by OCR.
• Functions independently and proactively with strong critical thinking, analytical, and communication skills.
• Manages study assignments for equitable distribution amongst team members, effectively prioritizes tasks, and follows-up to ensure completion of studies in a compliant and timely manner.
• Provides oversight to the assigned SCRFM for the study to facilitate timely and accurate completion of the study budget.
• 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.
• Provides policy and procedure interpretation to academic schools and departments/divisions related to research billing compliance.
• 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 seven years of experience in research administration or a health-related field.
• RN with some direct research nursing experience is strongly preferred.
• An equivalent combination of education, training and experience will be considered for candidates without a bachelor's degree.
• Possesses strong project management, facilitative leadership, detail orientation, and organizational skills.
• 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.

NOTE:

This role will be granted the opportunity to work from home regularly but must be able to commute to Emory University location as needed and at times, on short notice.

Emory reserves the right to change this status with notice to employee.


Emory Supports a Diverse and Inclusive Culture

Emory University is dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, gender, genetic information, age, disability, sexual orientation, gender identity, gender expression, and veteran's status.

Emory University does not discriminate in admissions, educational programs, or employment on the basis of any factor stated above or prohibited under applicable law.

Students, faculty, and staff are assured of participation in University programs and in the use of facilities without such discrimination.

Emory University complies with Executive Order 11246, as amended, Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity and affirmative action.

Emory University is committed to achieving a diverse workforce through application of its affirmative action, equal opportunity and nondiscrimination policy in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.

Inquiries regarding this policy should be directed to the Emory University Department of Equity and Inclusion, 201 Dowman Drive, Administration Building, Atlanta, GA 30322.

Emory University is committed to providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to request a reasonable accommodation, please contact the Department of Accessibility Services at V) | TDD). Please note that one week advance notice is preferred.


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Job Number _123605_


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_


Campus Location (For Posting) : City _Atlanta_


_Location :
Name_ _Emory Campus-Clifton Corridor_