Clinical Trials Regulatory Specialist III | School of Medicine - Pediatrics, Cystic Fibrosis

Emory • Atlanta, GA

1d • Hybrid

About The Position

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. Overseeing regulatory documentation and submission for clinical trials in Cystic Fibrosis, nonCF Bronchiectasis, and potentially other related disease states in collaboration with the established CF team. IRB submissions and documentation upkeep - local Emory and Children's Healthcare of Atlanta, Advarra, WIRB and other Central IRB systems as needed. Organization of e-Regulatory environment (Complion) as well as some paper regulatory records. Assisting in keeping up all regulatory items such as training, delegation and disemination of updates to clinical trials, and studies to keep staff up to date. Serve as resource for PIs and RCs for regulatory and human subjects related compliance needs, training and direction. Assisting with all CRA/Sponsor/monitoring regulatory needs. Directing any internal or external reviews or audits. Review patient records (EPIC and sometimes paper outside records) for compliance and internal monitoring for non-industry trials, studies and registries. Assisting in all clinical trial start up processes, logistics, Coverage Analyses (Emory and Children's), budget/contract development routing and navigation. Development of Source Documentation and Data Systems (likely REDCap) particularly for investigator-initiated trials. High level communication skills - particularly written skills - to communicate with monitors, study Sponsors, investigators, collaborators and research coordinators. Detailed knowledge of the following: 21 CFR Part 50 - Human subjects protection and confl icts of interest 21 CFR Part 56 - IRBs 21 CFR Part 11 - Electronic records and e-signatures 21 CFR Part 312 - INDs 21 CFR Part 46 - human subjects protections IPAA and GCP (ICH E6) Regulatory Specialist will be expected to provide oversight and support to investigators in these areas and help find solutions to nuanced questions. Resourcefulness is needed to be able to seek out answers and approaches - consulting with IRB contacts, OCR, Compliance and even Emory's Office of Technology Transfer and/or Office of Sponsored Programs for local navigation will be needed.

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.
• Knowledge of federal research regulations.
• 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.).
• High level of organizational skill.
• Familiarity with Complion e-Regulatory platform.
• Familiarity with Institutional Review Board processes - local and central (particularly Advarra and WIRB).
• Familiarity with Institutional Biosafety Committee submissions.
• Detailed knowledge of 21 CFR Part 50 - Human subjects protection and conflicts of interest.
• Detailed knowledge of 21 CFR Part 56 - IRBs.
• Detailed knowledge of 21 CFR Part 11 - Electronic records and e-signatures.
• Detailed knowledge of 21 CFR Part 312 - INDs.
• Detailed knowledge of 21 CFR Part 46 - human subjects protections.
• Detailed knowledge of IPAA and GCP (ICH E6).

Responsibilities

• Support regulatory affairs in clinical trials research.
• Manage the study activation process for basic to multiphase trials.
• Serve as the internal project manager for assigned oncology disease groups, providing updates on submissions and regulatory guidance.
• Act as a liaison between sponsors, investigators, Winship, Emory IRBs, external IRBs, and internal departments.
• Supervise and train Regulatory Specialist Is and IIs.
• Lead project-specific task forces and serve as project/process improvement leads.
• Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting.
• Prepare and review IND submissions in concert with IND Sponsors, communicate with the FDA, and prepare for FDA audits.
• Manage a load of 35+ trials per year (NCTN, industry, and investigator-initiated).
• Establish and maintain processes to ensure regulatory documentation complies with IRB policies and federal regulations.
• Review processes involving regulatory documentation, including NCTN/NCI informed consent review, to ensure appropriate timelines.
• Maintain study regulatory binders and electronic files.
• Coordinate protocol activation/maintenance process, ensuring regulatory documents are in place for enrollment.
• Disseminate information and coordinate or conduct training.
• Research and analyze problems, taking a leadership role in resolving them.
• Lead study start-up/maintenance, including preparing and submitting regulatory documents for new/current study applications.
• Participate in the development and implementation of standard operating procedures and regulatory orientation plans.
• Orient and mentor newly hired staff.
• Actively participate in designated committees within the unit and Emory University.
• Direct the clinical team to ensure protocol compliance.
• 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.
• Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance.
• Complete submission applications and other required documentation for various review committees.
• Serve as lead contact for assigned trials, maintaining records and corresponding with all parties involved.
• Complete protocol renewal and amendment applications.
• Attend research team meetings to report on regulatory updates and issues.
• Manage administrative duties corresponding to budgets and contracts.
• Handle single patient/compassionate use submissions and maintenance.
• Oversee regulatory documentation and submission for clinical trials in Cystic Fibrosis, nonCF Bronchiectasis, and potentially other related disease states.
• Manage IRB submissions and documentation upkeep for local and central IRBs (Emory, Children's Healthcare of Atlanta, Advarra, WIRB).
• Organize e-Regulatory environment (Complion) and paper regulatory records.
• Assist in maintaining regulatory items such as training, delegation, and dissemination of updates.
• Serve as a resource for PIs and RCs for regulatory and human subjects compliance needs.
• Assist with CRA/Sponsor/monitoring regulatory needs.
• Direct internal or external reviews or audits.
• Review patient records for compliance and internal monitoring for non-industry trials, studies, and registries.
• Assist in clinical trial start-up processes, logistics, Coverage Analyses, and budget/contract development.
• Develop Source Documentation and Data Systems (e.g., REDCap) for investigator-initiated trials.
• Communicate effectively with monitors, study Sponsors, investigators, collaborators, and research coordinators.
• Provide oversight and support to investigators regarding 21 CFR Parts 50, 56, 11, 312, 46, IPAA, and GCP (ICH E6).
• Seek out answers and approaches to regulatory questions by consulting with IRB contacts, OCR, Compliance, and Emory's Office of Technology Transfer and/or Office of Sponsored Programs.

Benefits

• 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).
• Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior