Emory Healthcare/Emory University Research Service Consultant in Atlanta, Georgia
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Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the diversity and excellence of our academic community.
Develops and manages a comprehensive, risk-based Quality Assurance (QA) program encompassing all aspects of the Office of Clinical Research (OCR) operational and compliance processes, leading to highly effective and efficient processes designed to ensure data and service quality throughout all OCR teams.
Assists with the optimal application of Federal, State, and local laws, guidance documents, Emory University Institutional policies, and Institutional Review Board (IRB) policies and procedures while meeting the objectives of the Emory University research community.
Consults on complex research and regulatory issues in conjunction with the team(s) to identify solutions and develop improvement processes.
Researches topics of departmental, institutional or strategic importance.
Serves as the central resource for the research community to provide expertise and guidance on complex issues, operational goals, business strategies, ethical considerations, regulatory mandates, and institutional policies related to human research protections.
Develops and facilitates training programs to accomplish goals.
Plans and conducts independent audits to assess compliance with regulations, guidelines, institutional policies, and operating procedures for the purpose of preventing and detecting inaccuracies and mismanagement, while promoting accountability and efficiency within OCR teams.
Prepares and distributes report of findings to the Executive Director and appropriate members of the Leadership Team.
Facilitates and tracks corrective action plans, in support of management, to foster completion and achieve compliance.
Thoroughly reviews complex study protocols and Informed Consent Documents (ICDs) to identify all Emory Healthcare (EHC) and/or Grady billable items and services required of the study which might generate a CPT code that requires a Prospective Reimbursement Analysis (PRA) to ensure research billing compliance.
Reviews Clinical Trial and Applicable Clinical Trial Determination Criteria for studies to ensure compliance with FDA, ICMJE, NIH, and Emory University policies and guidelines.
Facilitates and manages ClinicalTrials.gov activities associated with Emory-sponsored, investigator-initiated research studies.
Responsibilities may include, but are not limited to, operational functions across all OCR teams to ensure regulatory and institutional compliance with OCR operational functions including timely access to clinically relevant research information for research participants to promote patient safety; CMS regulations for billing items and services for clinical trials; budget coverage and recovery of costs for industry-sponsored clinical trials; FDAAA, NIH, and ICMJE requirements for Emory-Sponsored and Investigator-Initiated research studies; and mandatory training of investigators and coordinators conducting FDA-regulated clinical trials at Emory.
Works collaboratively and develops effective working relationships with investigators, key study personnel, and OCR staff to accomplish these goals.
Performs related responsibilities as required.
Bachelor's degree and five years of experience in research administration or a health-related field which includes direct research nurse or clinical research coordinator experience, or equivalent combination of education, training and experience.
Advanced degree preferred. Excellent oral and written communication skills.
Strong project management, facilitative leadership, analytical, critical thinking and organizational skills.
Strong knowledge of clinical processes, medical terminology, and the clinical research and grant life cycle.
Experience in an academic environment and knowledge of quality assurance and process improvement methodologies are preferred.
Certification in Healthcare Research Compliance through the Health Care Compliance Association is strongly preferred within five years of hire.
Knowledge of Emory's ERMS, OnBase, EPEX, Compass, Clinical Data Warehouse, OnCore, PowerTrials, PowerChart, ClinicalTrials.gov, RedCap, CITI, and eIRB systems are highly desirable.
Proficient working knowledge of Excel, Access databases, and Microsoft office.
NOTE: This role will be granted the opportunity to work from home temporarily during the COVID-19 pandemic, with intent to return to an Emory University location in the future. 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. Telephone: 404-727-9867 (V) | 404-712-2049 (TDD).
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 404-727-9877 (V) | 404-712-2049 (TDD). Please note that one week advance notice is preferred.
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Job Number 68686
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 Business Operations
Location : Name Emory Campus-Clifton Corridor
Campus Location (For Posting) : Location US-GA-Atlanta
Emory Healthcare/Emory University
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