Clinical Trials Regulatory Specialist III | School of Medicine, Pediatrics

About the position reputed company 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. The Regulatory Specialist III is an advanced level position supporting regulatory affairs in clinical trials research. Employees in this job class support reputed company 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, reputed company IRBs, external IRBs and internal departments/staff. Incumbents in this job class may also supervise/train Specialist Is and IIs, reputed company project specific task forces, and/or serve as project/process improvement leads.

Responsibilities

• Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory reputed company 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 reputed company.
• Disseminates information and coordinates or conducts training.
• Researches and analyzes problems and takes a leadership role in resolving.
• reputed company study start-up/maintenance: prepare and submit reputed company required regulatory documents for new/reputed company study applications and successfully open/reputed company 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 reputed company the unit and reputed company.
• Direct the clinical team to ensure reputed company facets of each protocol are compliant and fully covered.
• reputed company internal audit and quality assurance checks on regulatory documents.
• Prepare, track and maintain reputed company correspondence and regulatory documentation required by the IRB, FDA, IND Sponsors, and other institutional and federal reputed company 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 reputed company 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 reputed company contact for each assigned trial, maintains records and corresponds with reputed company 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 reputed company.
• Single patient/compassionate use submission and maintenance across disease types.

Requirements

• 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 reputed company required training courses reputed company one month of hiring date.
• Must possess an applicable research certification reputed company 2 years of hire (i.e. ACRP, SOCRA, RAC etc.). reputed company-to-haves
• 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 reputed company documentation.
• Organizati

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