Regulatory Affairs Study Start Up Specialist II

Regulatory Affairs Study Start Up Specialist II / Senior RASSU Job overview and primary responsibilities for a Regulatory Affairs Study Start Up Specialist II / Senior RASSU role. Responsibilities Assist/advise project teams on all regulatory requirements for clinical studies Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings Review and adapt study-specific documents according to each country and site requirements Perform IRB/EC (CA) and/or other Regulatory Bodies submissions on behalf of sponsors and/or sites as agreed with the Sponsor and in accordance with each country requirements Receive and process study documentation from sites, check content and quality as well as completeness Interact with site personnel, CPCs, CRAs and PMs for document corrections, clarification, or resolution of any incomplete and/or incorrect documentation found during document content quality review Compile Regulatory documentation according to CTI SOPs, sponsor SOPs and applicable country requirements; perform a QC review of all documentation before submitting to the sites, IRB/EC/CA and/or other Regulatory Bodies according to local requirements Assist with and adapt Informed Consent Form (ICF) according to IRB/IEC requests on country or site level Assist in preparation, quality check, and filing of site-adapted ICF according to local requirements Prepare and QC Clinical Trial Application forms (e.g., CTA, XML) where applicable Interact with Sponsors as needed; forward regulatory documentation, including final regulatory submission packages, if requested, to Sponsor in accordance with CTI or Sponsor SOPs Respond to Deficiency Letters from IRB/IEC/CA and/or other Regulatory Bodies in liaison with sponsor and study PM or assist sites in their response to IRB according to country and site requirements Compile and assess completeness of the Regulatory-Package for drug release (Regulatory Document Study Start Up Checklist) Provide project teams with accurate periodic status reports in accordance with CTI SOPs and attend internal and external project meetings as needed Accurately apply naming conventions, upload, and process all correct and complete study documentation in the study start-up module or trackers and study-specific TMF system whether electronic or paper Perform review, reconciliation, close-out, and archiving activities of study or project documentation according to CTI SOPs or sponsor SOPs Assist with preparation for Sponsor or Agency audits and inspections Assist with QC and QA of various study related Regulatory documents and reports Oversee translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scope Attend internal and external study meetings and regulatory status reports for each site and country during study meetings Sites budgets and sites contracts management, depending on Countries/Regions Required Education/Experience Associate or Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience At least 3–5 years of relevant pharmaceutical, site, or CRO Regulatory experience Experience in Clinical Trials Submissions in several LATAM countries Strong working knowledge and understanding of FDA, Good Clinical Practice (GCP) / International Council for Harmonisation (ICH) regulations and guidelines Competencies Ability to work well in a team environment Ongoing willingness to learn Detail oriented Excellent verbal and written communication skills Fluent in oral and written English Ability to develop, prioritize, organize, and manage multiple tasks Ability to provide superior level of customer service Proficient in use of computer and software systems Ability to maintain confidentiality Strong understanding and application of CRO industry principles, concepts, practices, and standards 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. 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 Why CTI? Advance Your Career – We invest in your professional growth. Our structured mentoring program, leadership development courses, and dedicated training department provide the support you need to excel. We also encourage ongoing education to help you achieve your professional goals. Join an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with hybrid work opportunities. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world. Make a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most. 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 ( 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 Seniority level Mid-Senior level Employment type Full-time Job function Legal Industries Research Services Referral notices: Referrals increase your chances of interviewing at CTI Clinical Trial and Consulting Services by 2x #J-18808-Ljbffr