Remote Senior Regulatory Trials Lead

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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 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:

• Overseeing regulatory documentation and submission for clinical trials in Cystic Fibrosis, nonCF Bronchiectasis, and potentially…