What You'll Do:
Regulatory Submission Management
- Prepare, review, and manage regulatory submissions under CTR (Clinical Trials Regulation) using CTIS.
- Handle regulatory submissions for medical devices, GMOs, and local country requirements in countries where CTIS is not mandated, including ethics committee submissions.
- Prepare and QC Clinical Trial Application forms (via CTIS or other national applicable systems), where applicable.
- Perform 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’s requirements.
- Respond to Deficiency Letters from EC/CA and/or other Regulatory Bodies in liaison with sponsor and study PM or assist sites in their response according to country and site requirements.
- Compile and assess the accuracy and completeness of the regulatory document approval package for drug release (Regulatory Document Study Start Up Checklist).
Regulatory Document Preparation and Review
- Review and adapt study-specific documents according to EU standards.
- Compile regulatory documentation according to CTI/sponsor SOPs.
- Assist with and adapt Informed Consent Form (ICF) according to EC requests at the EU level and liaise with country teams to ensure alignment with local requirements
- Support and modify the ICF in response to EC feedback at the EU level, coordinating with country teams to ensure alignment with local requirements.
- Assist in preparation, quality check, and filing of site-adapted ICF according to local requirements.
- Oversee regulatory document translation, as agreed in the scope.
- Assist with QC and QA of various study-related regulatory documents and reports.
Site and Team Interaction
- 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.
- Assist/advise project teams on all regulatory requirements for clinical studies.
- Provide project teams and sponsors with timely, accurate status reports and attend/present updates during internal and external project meetings, as needed.
- Attend internal and external study meetings and provide detailed regulatory status updates for each site and country.
- Interact with sponsors as needed; forward regulatory documentation, including final regulatory submission packages, if requested, to sponsor in accordance with CTI or sponsor SOPs.
Documentation Management and Compliance
- Receive and process study documentation from sites, checking content, quality, and completeness throughout all trial phases (start-up, maintenance, and close-out).
- Accurately apply naming conventions; upload and process all correct and complete regulatory documentation in the eTMF and/or study start-up module or trackers.
- Perform review, reconciliation, close-out, and archiving activities of regulatory documentation according to CTI SOPs or sponsor SOPs.
- Perform compliance assessments according to country requirements and document any activity discovered; notify PMs of any findings.
Audit and Inspection Support
- Assist with sponsor audits and Regulatory Agency inspections.
What You'll Bring:
- Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience.
- A minimum of 3 years of relevant Regulatory experience within a clinical research organization CRO, pharmaceutical industry, or site environment
- Fluent in English
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
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 tuition reimbursement and 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 generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. 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
