Located in Atlanta, Georgia, Emory University is one of the world’s leading research universities. A top-ranked, private institution dedicated to serving huma
Senior Research Compliance Specialist Research Integrity
Location
Georgia
Posted
2 days ago
Salary
0
Seniority
Senior
Job Description
Senior Research Compliance Specialist Research Integrity
Emory University
Title: Senior Research Compliance Specialist Research Integrity Location: Atlanta United States Job Number 165650 Job Type Regular Full-Time Division Research Administration Department Rsch Compl & Reg. Affairs Hybrid Job Description: 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,
Related Guides
Related Categories
Related Job Pages
More Compliance Jobs
Director of Enrollment Compliance
Regent UniversityBased in Virginia Beach, Virginia, Regent University is a faith-based institution of higher learning that seeks to train "Christian leadership to change the wor
Title: Director of Enrollment Compliance Location: United States Job Description: 50000394 Enrollment Management Staff & Administration Full time The Director of Enrollment Compliance serves as the institution's primary subject matter expert and quality assurance manager for all federal reporting required by the Registrar's Office, to the National Student Loan Data System (NSLDS) to ensure compliance with applicable regulations. Work Location: Virginia Beach, VA (qualified candidates may be considered for remote work depending on location) Essential duties: - Serve as the institutional lead for all NSLDS enrollment reporting, including managing submission cycles in accordance with federal requirements and any National Student Clearinghouse (NSC) participation agreements. - Tracks and monitors enrollment reporting transmissions from submission to completion to ensure adherence to the federal reporting obligation. - Establish, document, and quality check the date of determination for enrollment status changes and maintain accurate audit trails in the Student Information System, Banner, to support compliance and program reviews. This includes monitoring student record requests, such as add/drop forms. - Monitor NSC and NSLDS processing timelines and provide any necessary adjustments to ensure compliance timelines. - Resolve all enrollment reporting error reports in a timely manner, including the SSCR report. - Serve as a liaison between the Registrar's Office and the NSC, including escalating reporting issues in collaboration with the University Registrar, and between the University Registrar, Regent's internal auditor, and the Office of Financial Aid. - Perform quality assurance and control checks on enrollment data submissions to ensure accuracy and compliance, including pre-submission audits of enrollment data files. - Develop and maintain internal quality assurance procedures, checklists, and reconciliation workflows to reduce error rates and data consistency. - Monitor regulatory changes and updates to federal and state guidance to ensure full university compliance. - Create and maintain policy guides and training resources related to enrollment reporting for the Registrar's Office. - Manage the institution's Degree Verify reporting process through the NSC to ensure timely and accurate submission of degree conferral data in alignment with degree conferral cycle. Qualifications: - Bachelor's degree required - Master's degree preferred - Preferred degree in higher education administration, business, information systems, or related field - Minimum of three (3) years of direct experience with NSC / NSLDS enrollment reporting Candidates must have: - Demonstrated knowledge of federal enrollment reporting requirements under Title IV - Must be eligible to be recommended and approved to access the NSLDS - Proficiency with Ellucian Banner systems or comparable student information system - Strong analytical skills with high attention to detail and a commitment to data accuracy - Knowledge of FERPA regulations and its application to student records management - Data analytical skills to perform analyses and report utilizing software (e.g., Excel) - Commitment to Regent’s core values of Excellence, Innovation, and Integrity Regent University does not discriminate in employment in its programs or activities on the basis of race, color, national or ethnic origin, sex, disability, age or veteran status. For full Non-Discrimination Policy click here. Benefits Regent offers a wide range of generous benefits including health, life and disability insurance; flexible spending accounts; tuition incentives; fully vested retirement plans; life and disability insurance options, time off, and more. All regular faculty and staff serving at Regent and working a minimum of 30 hours per week will receive an attractive benefits package.
Global Trade Compliance Leader
ParexelParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
• Develop import/export strategies for international projects • Ensure compliance with global trade regulations • Oversee trade activities and manage regulatory risks • Collaborate with cross-functional teams to achieve project objectives
Temp Regulatory Consultant
BrukerWe offer high-performance scientific instruments and high-value analytical and diagnostic solutions.
• Maintain Regulatory Affairs documents, policies, plans and procedures to support compliance with regulatory requirements • Review labeling/promotional/advertising materials, and other documents to ensure regulatory compliance • Represent and/or lead Regulatory affairs in project team meetings throughout the lifecycle of large-scale projects • Assist in the interpretation and submission of domestic and international regulatory registrations, testing and certifications • Assist regulatory initiatives for compliance and risk management • Interpret Regulatory Affairs policies and guidance and correctly apply them as regulatory activities • Manage for the successful execution of regulatory plans • Participate in internal and external Quality and Regulatory audits • Maintain current knowledge of relevant regulations and trends, including proposed and final rules
Director, Regulatory CMC
Iovance Biotherapeutics, Inc.Iovance is a patient-centric, collaborative organization that is driven to change the way cancer is treated.
• Works closely with functional leaders to create the optimal development path for Iovance product candidates, negotiate optimal development paths within internal cross-functional teams and with health authorities, execute clinical-regulatory development plans on-time and while managing all identified risks. • Plans, manages, and creates Clinical Trial Applications, Market Applications and amendments. • Ensures that submission documents and correspondence are of the highest quality in terms of content, organization, clarity of writing, and accuracy. • Leads cross-functional teams in preparing for health authority meetings. • Ensures that evolving global regulations, guidelines and health authority expectations, especially those related to cell therapies, are incorporated into program decision making. • Works within the department and with other functional areas on process improvements. • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. • Perform miscellaneous duties as assigned.



