[Hiring] Clinical Trials Regulatory Specialist III @Emory University

Role Description

Winship is seeking qualified candidates for the Clinical Trials Regulatory Specialist III position. The Regulatory Specialist III is an advanced level position supporting regulatory affairs in clinical trials research.

• Support all trial complexities (basic to multiphase) and manage the study activation process.
• Serve as the internal project manager for assigned specific oncology disease group(s), providing timely updates on submissions and regulatory guidance on study development.
• Liaison between the sponsor, investigator, Winship, Emory IRBs, external IRBs, and internal departments/staff.
• May 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.
• Prepare and review IND submissions, communicate with the FDA, and prepare for FDA audits in concert with IND Sponsors.
• Responsible for 35+ trial load per year of NCTN, industry, and investigator-initiated trials.
• Establish and maintain processes and monitor practices to ensure regulatory documentation complies with IRB policies and procedures.
• Review processes involving regulatory documentation, including 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 communicate to allow for enrollment to start and maintain once regulatory documents are in place.
• Disseminate information and coordinate or conduct training.
• Research and analyze problems and take a leadership role in resolving.
• Lead study start-up/maintenance: prepare and submit all required regulatory documents for new/current study applications.
• Participate in the development and implementation of standard operating procedures and orientation plans.
• Actively participate 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 oversight committees.
• 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.
• Complete submission applications, and other required documentation, prepares protocol specific forms for submission to various review committees.
• Serve as lead contact for each assigned trial, maintain records, and correspond with all parties involved.
• Complete protocol renewal applications and amendment applications.
• Attend 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.
• Perform related responsibilities as required.

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.).

Company Description

Winship Cancer Institute of Emory University is Georgia’s only National Cancer Institute-designated Comprehensive Cancer Center, dedicated to discovering cures for cancer and inspiring hope.

• Researching, developing, teaching, and providing novel and highly effective ways to prevent, detect, diagnose, treat, and survive cancer.
• Leading cancer specialists collaborating across disciplines to tailor treatment plans to each patient’s needs.
• Innovative therapies and clinical trials, comprehensive patient and family support services, and a personalized care experience.