Regulatory Affairs Study Start Up Coordinator

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

What You'll Do

• Assist in compilation and revision of Regulatory Affairs (RA) documents required for clinical trials submissions
• Assist in the contact with local study teams for RA documents collection and checks, when applicable
• Assist in contacting sites to obtain maintenance documents throughout the trial
• Assist in quality checks of documents in the study start up module and the eTMF
• Assist in pulling expiration reports and reconciliation reports
• Assist in managing the RASSU SharePoint
• Maintain resourcing tracker for staff assignments and future awarded work
• Assist is preparing site timelines for IRB reviews presented in Bid Defenses
• Assist in Business Intelligence (BI) report tracking
• Assist in preparation of study submission packages (Initial Submissions, Substantial Amendments and Non-substantial Amendments) to Ethics and Regulatory Bodies, according to countries requirements
• Arrange for shipments of regulatory documents and packages, track and retrieve items
• Assist in the management of the documents to be translated, when applicable
• Assist in SUSARs submission package preparation to Central and Local Ethics Committees in applicable countries
• Assist in the preparation and completion of specific trackers
• Assist in applying naming conventions, upload study documentation in the study start-up module or trackers and study specific TMF system whether electronic or paper Provide backup support for RA activities, as needed
• Provide any other administrative support to RASSU team members
• Participate in relevant trainings
• Assist in the development of Project specific Work Instructions
• Update RASSU specialists and Directors on outstanding items, and issues as they arise
• Attend weekly team meetings, prepare and distribute agendas, prepare and distribute meeting minutes, if requested

What You'll Bring

0 – 1 year of research related experience and or regulatory experience

Competencies

• Ongoing willingness to learn
• Detail oriented
• Ability to collaborate well in a team environment
• Ability to maintain confidentiality
• Proficient in use of computer and software systems
• 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

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 () 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