Clinical Trials Regulatory Specialist III

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.

KEY RESPONSIBILITIES:

• 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.
• Incumbents in this job class may also supervise/train Specialist Is and IIs, lead project specific task forces, and/or serve as project/process improvement leads.
• Duties include:
  • 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.
  • Process IND safety reports, maintain documentation of PI review and submit safety reports to the IRB as appropriate.
  • Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional, and federal regulations.
  • Completes submission applications, and other required documentation, prepares protocol specific forms for submission to various review committees, including internal scientific review boards, the IRB and sponsoring entities.
  • Serves as lead contact for each assigned trial, maintains records and corresponds with all parties involved (institutional, federal, pharmaceutical).
  • Completes protocol renewal applications and amendment applications.
  • Attends research team meetings to report on regulatory updates and issues. Responsible for administrative
  • duties corresponding to budgets and contracts.
  • Single patient/compassionate use submission and maintenance across disease types.
• Performs related responsibilities as required.

ADDITIONAL JOB DETAILS: 

• Submission and documentation: Prepare and submit all necessary documentation for new trials, amendments, and continuing reviews to IRBs and other regulatory bodies.
• Regulatory oversight: Maintain regulatory files, ensure ongoing compliance, and prepare for potential audits.
• Liaison: Serve as a primary point of contact and communicate with sponsors, investigators, and internal and external regulatory entities.
• Safety reporting: Facilitate and oversee the regulatory aspects of safety reporting for assigned trials.
• Project management: Act as an internal project manager, guiding the study activation process and managing the regulatory status of multiple complex trials.
• Leadership and training: May supervise and train Regulatory Specialist I and II staff, lead task forces, and serve as a process improvement lead.
• Compliance: Ensure study adherence to protocols, federal regulations, and professional guidelines.

PREFERRED QUALIFICATIONS: 

• Experience: Typically requires a Master's degree and several years of experience in clinical research, with a focus on regulatory affairs.
• Knowledge: Strong knowledge of federal regulations, IRB processes, and relevant guidelines (e.g., ICH/GCP) is essential.
• Communication: Excellent verbal and written communication skills are required for interacting with various stakeholders.
• Attention to detail: A high level of accuracy and attention to detail is critical for managing complex documentation.
• Organizational skills: Must be highly organized and able to manage a large workload, often involving multiple trials.
• Computer proficiency: Strong computer skills, including experience with clinical trial management systems and standard office software, are necessary.

MINIMUM QUALIFICATIONS:

• Bachelor's degree and five years of experience in a research environment, or an equivalent combination of experience, education and training.
• Knowledge of IRB processes, federal research regulations and a basic understanding of funding programs and clinical research practices.
• Must obtain all required training courses within one month of hiring date.
• Must possess an applicable research certification within 2 years of hire (i.e. ACRP, SOCRA, RAC etc.).

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.

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 Telephone: V) | 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 at or call Voice) | TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination.