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Senior Research Compliance Specialist - Research Integrity

Emory Healthcare/Emory University

Atlanta, GA

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JOB DETAILS
SKILLS
Affirmative Action, Analysis Skills, Continuous Improvement, Corrective Action, Documentation, FDA (Food and Drug Administration), Federal Laws and Regulations, Healthcare, IDE (Integrated Development Environment), Internal Audit, Investigational New Drug (IND), Leadership, Legal, Maintain Compliance, Metrics, People Management, Problem Solving Skills, Program Evaluation, Regulations, Regulatory Compliance, Rehabilitation Act, Reporting Skills, Research Administration, Research Skills, Risk, Risk Analysis, State Laws and Regulations, Stem Cells, Support Documentation, Training/Teaching, University/School Regulations, Work From Home
LOCATION
Atlanta, GA
POSTED
6 days ago


Discover Your Career at Emory University

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 excellence of our academic community.

Description

JOB DESCRIPTION: + The Senior Research Compliance Specialist ensures institutional compliance with federal, state, sponsor, and university research regulations and policies. + This role conducts compliance reviews and risk assessments, supports investigations and issue resolution, provides training and guidance, and contributes to the development and continuous improvement of research compliance programs. + The position partners closely with faculty, research staff, and central administration to promote a strong culture of compliance and responsible research conduct. + Senior Research Compliance Specialists may be assigned one or more regulatory specializations based on institutional needs. + These specializations define the primary regulatory focus and required subject-matter expertise for the role, such as research integrity, controlled substances, research cybersecurity, or research security. + Conducts risk-based reviews, audits, and monitoring of research activities to assess compliance with applicable regulations, sponsor requirements, and institutional policies. + Supports and manages investigations and issue resolution related to research compliance, including documentation, analysis, reporting, and corrective and preventive actions. + Develops, implements, and maintains research compliance policies, procedures, guidance, and operational tools. + Provides training, education, and consultative support to faculty, research staff, and administrators on research compliance requirements. + Prepares reports, metrics, and documentation to support compliance monitoring, program evaluation, and leadership reporting. + Maintains accurate and secure program records and ensures the integrity and confidentiality of sensitive information. + Collaborates with departments, committees, central offices, and external partners (e.g., IT, vendors) to support research compliance programs and enterprise systems. + Contributes to continuous improvement of research compliance programs and promotes a positive culture of compliance and responsible research conduct. + Performs related responsibilities as required. Regulatory Specialization: The Senior Research Compliance Specialist may be assigned one or more regulatory specializations based on institutional needs. Regulatory specializations define the primary regulatory domain and subject-matter expertise required for the role and do not change the underlying job classification. Research Integrity • Supports intake, assessment, and review of research misconduct allegations. • Assists with research integrity investigations, including evidence review, interviews, documentation, and reporting. • Provides guidance on research integrity policies, procedures, and responsible conduct of research requirements. • Supports FDA inspections, IND/IDE application reviews, stem cell reviews and other research regulatory assistance as needed MINIMUM QUALIFICATIONS: + Bachelor's degree and five years of experience in research administration, research compliance, internal audit, legal, audit, or a related field. + Experience in a university or research environment involving heavily regulated industries preferred. + Juris Doctorate or master's degree and Certified Compliance and Ethics Professional (CCEP), Certified in Healthcare Research Compliance (CHRC), or similar certification preferred. NOTE: This role will be granted the opportunity to work from home regularly but must be able to commute to Emory University on a flexible weekly schedule based upon business needs. Schedule is based on agreed upon guidelines of department. This role requires residency in the state of GA. Emory reserves the right to change remote work status with notice to employee.

Additional Details

Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with 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 (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: 404-727-9867 (V) | 404-712-2049 (TDD). Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services ataccessibility@emory.eduor call 404-727-9877 (Voice) | 404-712-2049 (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination.

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Job Number

_165650_

Job Type

_Regular Full-Time_

Division

_Research Administration_

Department

_Rsch Compl & Reg. Affairs_

Job Category

_Research Administration_

Campus Location (For Posting) : Location

_US-GA-Atlanta_

_Location : Name_

_Emory Campus-Clifton Corridor_

Remote Work Classification

_Hybrid Remote_

Health and Safety Information

_Not Applicable_

About the Company

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Emory Healthcare/Emory University