Principal Regulatory Affairs, Study Start Up Specialist

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

What You'll Do

• Study Document Preparation
  •  Coordinate with sponsor and Project Management Team to prepare and submit the required core documents across all regions.
  •  Develop and maintain the Regulatory Clinical Trial Submission Plan regionally and globally
  •  Prepare review and adapt: Study Informed Consent Forms (ICF).
  • Collaborate with Site Budgets and Contracts teams to prepare global templates required for regulatory clinical trials submissions
• Site Document Collect and Quality Check 
  • Oversee and coordinate with site staff for document collection, corrections and clarifications for studies submission and Regulatory green light package. 
• Regulatory Submissions to Institutional Review Board (IRB) / Independent Ethics Committee (IEC) / Competent Authority (CA) and Regulatory Bodies
  • Compile, organize, and check for accuracy of regulatory documents to ensure compliance with SOPs and local requirements. 
  • Review clinical trial application forms. 
  • Communicate with sponsors as needed, including forwarding regulatory submission packages per SOPs. 
  • Oversee the study submission packages (Initial Submissions, Substantial Amendments and Non-substantial Amendments) to IEC and Regulatory Bodies, in accordance with country-specific requirements.
  • Define and oversee regional and global submissions strategy with the project management team and sponsor.
  • Oversee Part I for EU/EEA and Part II submissions for EU/EEA via CTIS, as required.   
  • Provide guidance and ensure consistency in responding to deficiency letters or information requests from IRB, IEC, or regulatory bodies, across regions or globally, by coordinating with sponsors, study project managers, or sites as needed.
• Regulatory Green Light Package (GLP)
  • Oversee, organize, and check for accuracy of the essential documents for regulatory GLP regional and globally.  
  • Oversee and update information regarding GLP documents status in applicable tracking system.  
  • Conduct quality checks of documents within the study start-up module and the eTMF.
• Trial Master File
  • Quality Control (QC) check all required study documents in applicable TMF, when required. 
  • Oversee the review, reconciliation, close out, and archival of project documents per CTI or sponsor SOPs. 
• Documents Translation
  • Coordinate regulatory documents for translation, including contact with translation vendor, when required.  
• Study Regulatory Status
  • Oversee and manage tracking systems for study-related reports. 
  • Quality control and quality assurance of various regulatory documents and study-related reports.  
  • Prepare and participate in study meetings. 
  • Lead meetings when appointed to the global regulatory lead role.   
• Regulatory Support and Compliance
  • Provide guidance to project teams regarding all regulatory requirements for clinical studies. 
  • Support compliance assessments in accordance with local regulations, document any identified activities, and promptly inform Project Managers of notable findings. 
  • Oversee, consult, and support global RASSU with Unit Tracking completion and identify Out-of-Scopes for RASSU study-related activities.
  • Coordinate with regional and country teams to ensure all submission requirements, including national submissions and fee payments, are completed in accordance with local regulations.
  • Provide oversight of import/export documentation for clinical supplies and liaise with brokers for customs clearance, as required.
  • Oversee SUSAR submission packages to IRB/IEC/CA and other regulatory bodies, as applicable.
  • Oversee shipment, tracking, and retrieval of regulatory documents and submission packages.
  • Contribute and prepare for Sponsor or Agency audits and inspections. 
  • Train and mentor RASSU staff within their job responsibilities on regulatory processes and best practices.
  • Demonstrate a strong sense of urgency by prioritizing critical tasks, acting promptly to resolve issues, and ensuring timely delivery of results without compromising quality. 
  • Participate in department and/or company initiatives.
  • Perform line management responsibilities as assigned by RASSU leadership.
• What You'll Bring
  • At least 8 years of research, regulatory, or other relevant experience with transferable skills
  • Bachelor’s Degree in allied health fields such as nursing, pharmacy or health/ natural science or the equivalent relevant experience
• Competencies
  • Organizational, time and personnel management skills
  • Detail oriented 
  • Collaborate well in a team environment
  • Ability to maintain confidentiality 
  • Proficient in use of computer and software systems, with experience in Microsoft tools to edit, re-format and finalize documents
  • Excellent verbal and written communication skills  
  • Fluent in oral and written English 
  • Ability to provide superior level of customer service 
  • Ability to develop, prioritize, organize, and manage multiple tasks 
  • Ability to develop others through effective coaching and mentoring through feedback, guidance, and accountability
  • Strategic decision making and creative problem-solving skills
  • Excellent strategic leadership skills

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering hybrid work from home opportunities. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market. 

Important Note

In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.

Please Note

• We will never communicate with you via Microsoft Teams or text message
• We will never ask for your bank account information at any point during the recruitment process