Emory University

Compliance

• The Regulatory Specialist III is an advanced level position supporting regulatory affairs in clinical trials research.
• Employees in this job class support all trial complexities (basic to multiphase) and manage the study activation process.
• Serves as the internal project manager for assigned specific oncology disease group(s), providing the group with timely updates on the status of submissions and regulatory guidance on study development.
• Liaison between the sponsor, the investigator, Winship, Emory IRBs, external IRBs and internal departments/staff.
• Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting.
• In concert with IND Sponsors, prepare and review IND submissions, communicate with the FDA, and prepare for FDA audits.
• Responsible for 35+ trial load per year of NCTN, industry and investigator-initiated trials.
• Establishes and maintains processes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies and procedures and regulations.
• Reviews processes involving regulatory documentation, including but not limited to NCTN/NCI informed consent review, to assure appropriate timelines are followed.
• Maintain study regulatory binders and electronic files in accordance with institutional and sponsor requirements.
• Coordinate protocol activation/maintenance process and communicates to allow for enrollment to start and maintain once regulatory documents (e.g. DSMC review) are in place.
• Disseminates information and coordinates or conducts training.
• Researches and analyzes problems and takes a leadership role in resolving.
• Lead study start-up/maintenance: prepare and submit all required regulatory documents for new/current study applications and successfully open/close studies from inception to accrual.
• Participates in the development and implementation of standard operating procedures, development and revision of regulatory orientation plans, and orientation and mentorship of newly hired staff.
• Actively participates in designated committees within the unit and Emory University.
• Direct the clinical team to ensure all facets of each protocol are compliant and fully covered.
• Perform internal audit and quality assurance checks on regulatory documents.
• Prepare, track and maintain all correspondence and regulatory documentation required by the IRB, FDA, IND Sponsors, and other institutional and federal oversight committees, including drafting and reviewing content as appropriate.

Clinical Trials Regulatory Specialist III

Clinical Research

• Support day-to-day study operation, including home dialysis patient and caregiver participant recruitment, data collection, retention activities, tracking study visits/calls, and data management.
• Develop and update SOPs and other related study documents.
• Manage research project databases, develops flow sheets and other study related documents, and completes source documents/case report forms.
• Provide guidance to less experienced staff.
• Interface with research participants, determines eligibility and consents study participants according to protocol.
• Approve orders for supplies and equipment maintenance.
• Assist in developing recruitment strategies and conducting screenings for study participants including interviews and questionnaires.
• Supervise collection of study specimens and processing.
• Establish case packages for study procedures, monitor scheduling of procedures and charges, coordinate other services as needed.
• Ensure compliance with research protocols, review case report forms and audits for accuracy with source documents, attend monitoring meetings with sponsors.
• Prepare regulatory submissions.
• With appropriate credentialing and training may perform phlebotomy or diagnostics.
• Perform related approved responsibilities as required.

Clinical Research Coordinator II – Home Dialysis

Operations

• Oversees the day-to-day operation of business unit-facing facility operations
• Responsible for ensuring a positive facilities experience for students, faculty, and staff
• Oversees negotiation of contracts for safety, environmental, and maintenance solutions
• Manages operating budgets and maintenance, rehabilitation, and repair activities
• Directly supervises a staff of six and indirectly supervises approximately 500 employees
• Addresses all emergency situations in the facilities area
• Assists the Associate Vice President with projects and staffing levels
• Interacts with internal and external customers and presents to departments and campus constituents

Senior Director, Facility Operations – Campus Services

Security Engineer

• Collaborates with the Cybersecurity and IAM teams to ensure secure onboarding and offboarding of applications into the SSO environment.
• Designs or consults on the application integration approach to enable secure access/SSO.
• Validates and maintains application integration configurations to meet cybersecurity and compliance requirements.
• Assists in developing and ensuring alignment of implementations or changes with access control policies and security standards.
• Supports audits and compliance reviews related to IAM and application integrations by facilitating responses via the proper SMEs.
• Maintains the CI's that relate to federated applications in the Configuration Management Database (CMDB), ensuring application records are accurate, complete, and current.
• Manages the application catalog to ensure all integrated applications are tracked with appropriate metadata (e.g., owners, contacts, technical details, integration type).
• Leverages ServiceNow to manage requests, incidents, and changes related to application integrations and IAM processes.
• Coordinates application onboarding and offboarding processes, including requirement gathering, integration configuration, testing, and documentation.
• Works with application owners to ensure smooth transitions during onboarding/offboarding.
• Maintains end-to-end lifecycle documentation for each application in scope.
• Creates and maintains detailed documentation for application integrations, onboarding/offboarding procedures, and CMDB updates.
• Gathers and analyzes enhancement requests from stakeholders, prioritizes them, and coordinates with technical teams for implementation.
• Identifies opportunities to streamline IAM-related processes and improve integration workflows.
• Assists in engineering modern applications that support the SSO integration intake process and application inventory.
• Troubleshoots, develops, and supports in multiple IDPs including Entra ID and Shibboleth IDP.
• Serves as On-Call rotation for IDP support as needed.
• Performs other related duties as required.

Federated Security Engineer

Graphics Designer

• Coordinates and creates a variety of graphic design work
• Participates in the process to determine visual design needs, executes jobs from concept to design, and follows through to the final production of the project for print, web, or digital applications
• Plays a vital role in developing and maintaining a cohesive visual identity that aligns with Emory's mission
• Designs projects from conceptualization to execution, collaborating closely with creative leadership, copywriters, other designers, photographers, videographers, strategists, freelance artists, and other stakeholders
• Ensures deliverables meet creative briefs and aligns with Emory's business and brand goals
• Contributes to the creative process, including team brainstorms and presentations
• Works in a collaborative and creative environment, fostering a culture of creativity, collaboration, inspiration, and continuous improvement
• Provides clear communication and articulates rationale regarding creative vision, strategy, and justifications
• Follows workflow processes and leverages the project management system to ensure projects are completed efficiently
• Keeps interested parties informed about projects on a regular basis
• May lead production for print projects, including vendor selection, spec sheets, estimations, proofing, and press checks when necessary
• Manages vendor relationships for quality, accuracy, and brand consistency
• Stays up to date on industry trends, including the latest skills, techniques, and best practices in the field of visual design, higher education, and marketing.

Environmental Graphics Designer

Administrative Assistant

• Provides administrative support to the highest level of administration within the organization
• Handles meeting and conference logistics
• Prepares and monitors budgets and project proposals
• Researches and compiles information for reports and presentations
• Maintains calendar for one or several executives
• Reviews incoming correspondences to executive and forwards appropriately
• Leads meetings addressing specific operational issues
• Assists in the administration and interpretation of policies and procedures
• May supervise and schedule clerical and secretarial staff

Executive Administrative Assistant

Engineer

• The Senior Cyber Defense Engineer has responsibilities in multiple information security disciplines relevant to the team such as: incident response, vulnerability management, intrusion detection and prevention, threat intelligence, and security operations, in cloud and on-premise environments.
• Investigates and responds to cyber incidents within the network environment.
• Collects data from a variety of security monitoring tools, including intrusion detection system alerts, firewall and network traffic logs, and host system logs to analyze events that occur within the environment.
• Determines and documents information security requirements and controls necessary for the protection of information resources.
• Provides guidance and assistance regarding information security matters such as the interpretation of information security policies and requirements or their applicability to particular situations.
• Participates in information security incident response activities, risk assessment and risk management activities, and vulnerability assessment and vulnerability management activities spanning multiple business units.
• Participates in information security projects and initiatives.
• Performs operational tasks supporting information security functions such as intrusion detection and prevention, security monitoring, vulnerability remediation, security incident prevention and remediation.
• Supports, maintains, monitors, troubleshoots and enhances security monitoring and response tools, methodologies, software, and hardware.
• Analyzes data from Information Security tools and provides reports and recommended response actions to Information Security management.
• Represents Information Security to other organizations on information security related matters, as assigned.
• Publishes regular status reports and submits to management.
• Performs related responsibilities as required.

Senior Cyber Defense Engineer

Director

• This position serves as team liaison to a defined group of development officers and leads strategic portfolio review meetings, including quantitative and qualitative analysis of prospect portfolios while ensuring portfolios are filled according to portfolio management guidelines with the most appropriate prospects.
• Prepares data and reports for regularly scheduled portfolio review meetings with development officers.
• Leads the review and approval process, in partnership with relationship managers, for removing prospects from portfolios.
• Partners with Prospect Analytics team and other Pipeline Optimization team members to identify and assign potential Emory Healthcare patient prospects to portfolios, participate in regular portfolio updates, and provide ad-hoc reporting.
• Synthesizes and analyzes prospect data, conducts and reviews audits, and monitors data integrity for the purpose of improving the quality of the prospect specific data.
• Performs other related duties as assigned.

Assistant Director, Patient Prospect Development – Advancement and Alumni Engagement

Network Engineer

• Support the configuration, installation, maintenance, and troubleshooting of network services and devices
• Monitor critical processes for Emory's enterprise-wide systems and applications
• Address interruptions and failures
• Interact with customers to resolve network issues
• Perform inspections and upgrades
• Develop and maintain documentation
• Maintain 24 x 7 coverage and support, including on-call support

Network Analyst – Technician

Accounts Payable

• Oversees daily operations of accounts payable staff
• Directs processing of accounts payable paperwork
• Assigns vendor numbers and oversees auditing, data entry, mail distribution, and customer inquiries
• Analyzes vendor statements and reconciles discrepancies
• Processes stop payment requests and works with Accounting to void checks
• Maintains required files and records

Accounts Payable Coordinator – Temporary

• Represents the CFDE in collaborations with other campus leaders
• Leads long-term planning to support faculty community-engaged teaching and scholarship
• Plans, develops and implements workshops related to community engagement
• Recruits speakers and conducts one-on-one teaching consultations
• Designs related programming and manages the engaged learning budget
• Contributes to CFDE communications and website related to pedagogy
• Administers a grant program for community-engaged learning
• Represents Emory in managing institutional membership in national organizations

Director, Engaged Learning

• Manages scheduling of equipment maintenance to meet FDA GMP guidelines
• Establishes and oversees facility cleaning services and schedule
• Establishes equipment life cycle for anticipated annual repair/replacement costs
• Manages all equipment/room alarm systems
• Interfaces with Emory Hospital for alarm notifications, establishes appropriate alarm response procedures
• Leads IQ/OQ/PQ for all equipment onboarding and qualification
• Ensures adherence to cGMP, FDA, and internal standards; manage documentation, CAPAs, and lead audits
• Oversees preventative/predictive maintenance for critical systems (HVAC, WFI, refrigeration) and equipment
• Selects, manages, and coordinates external service providers for projects and maintenance
• Develops, manages, and controls facility budgets; oversees facility upgrades and capital projects
• Manages gowning, cleaning/sanitization programs, and product changeovers
• Enforces safety protocols, leads equipment/environment specific risk assessments, and ensures environmental compliance
• Works with QA/QC, Production, and other departments

Facilities Operations Manager – Good Manufacturing Practices

Research Scientist

• Work with research teams specific to statistical data analysis and research tasks.
• Supervision of a Principal Investigator on ongoing biostatistical and health science projects.
• Apply quantitative methods to real-world research questions.
• Clean, manage, and prepare research data from clinical, survey sources.
• Perform statistical analyses.
• Document data processing steps and maintain reproducible data workflows.

Research Assistant, Temporary

Analyst

• Leads efforts to ensure informatics systems support and advance the research objectives and mission of Emory University
• Works directly with researchers to document, analyze, and translate their needs into technical designs and informatics solutions
• Utilizes standard software requirements and design practices to document informatics solutions to support a wide range of research activities across the university
• Leads project team from concept to closeout phase
• Applies biomedical informatics technical standards, methodologies, and principles to research-specific program needs, objectives, and outcomes
• Manages related systems projects from a client business perspective
• Ensures a high level of client satisfaction by monitoring the delivery of ongoing information systems to the enterprise

Lead Research Informatics Analyst

Research Analyst

• Performs a variety of defined research and laboratory tests and experiments according to prescribed protocols and assigned schedules
• Sets up experiments as prescribed by a principal investigator
• May be required to participate in laboratory maintenance activities such as sterilization and cleaning of equipment, ordering of supplies, inventory and media preparation
• Maintains records, files and logs of work performed in laboratory notebooks and computer databases
• Compiles data and records results of studies for publications, grants and seminar presentations
• Performs related responsibilities as required by principal investigator.