Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Support clinical trials by managing regulatory documents and ensuring compliance.
- Company: Join CTI Clinical Trial and Consulting Services, a leader in clinical research.
- Benefits: Gain valuable experience in the healthcare industry with potential for career growth.
- Why this job: Be part of impactful clinical trials that contribute to medical advancements.
- Qualifications: Ideal for recent graduates with a passion for healthcare and research.
- Other info: Collaborative team environment with opportunities for professional development.
The predicted salary is between 36000 - 60000 ÂŁ per year.
The Regulatory Affairs Study Start-up (RASSU) Department is seeking a dedicated individual to provide comprehensive administrative and regulatory support on clinical trials study submissions. This role will be instrumental in ensuring the smooth management and execution of regulatory affairs processes related to clinical trial submissions and ongoing compliance.
What You’ll Do
- Assist in compilation and revision of Regulatory Affairs (RA) documents required for clinical trials submissions, primarily in the UK, but also in other regions as needed.
- Coordinate with local study teams for RA document collection and checks, when applicable.
- Contact research sites to obtain maintenance documents throughout the trial.
- Conduct quality checks of documents in the study start‑up module and the eTMF.
- Generate and review expiration and reconciliation reports to ensure compliance and completeness.
- Manage the RASSU SharePoint platform for document storage and collaboration.
- Assist in preparation of study submission packages (Initial Submissions, Substantial Amendments, and Non‑substantial Amendments) to Ethics and Regulatory Bodies, according to country‑specific requirements.
- Arrange for shipments tracking, and retrieval of regulatory documents and packages as needed.
- Manage translation requests of documents and liaise with the translation vendor.
- Assist in the preparation of SUSAR submission packages for both Central and Local Ethics Committees as required.
- Assist in the preparation and completion of specific trackers to monitor project progress.
- Apply standardized naming conventions and upload study documentation to the study start‑up module or trackers, and to the study‑specific TMF system whether electronic or paper.
- Provide backup support for RA activities, as needed.
- Offer additional administrative support to RASSU team members.
- Participate in relevant training sessions to stay current with industry practices and regulatory updates.
- 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, and prepare and distribute meeting minutes, if requested.
What You Bring
- 0–1 year of research or regulatory experience.
- Basic knowledge of medical and pharmaceutical terminology.
- Good understanding of the drug development and clinical trial process.
- Proficiency in Microsoft tools to edit, reformat and finalize legal regulatory documents.
- Bachelor’s Degree in allied health fields such as nursing, pharmacy or health/natural science.
- Excellent verbal and written communication skills.
- Excellent command of English language (verbal and written).
- Strong organizational and record‑retention skills.
- Strong interpersonal skills.
- Strong computer skills.
- Ability to work independently.
- Ability to handle multiple tasks and manage time efficiently.
Important Note: If you are selected for the next phase, a member of our team will contact you directly from an @ctifacts.com email address. Please apply only through our website (www.ctifacts.com) or our verified LinkedIn page. We will never communicate via Microsoft Teams or text message, and we will never ask for your bank account information during the recruitment process.
RASSU Coordinator employer: CTI Clinical Trial and Consulting Services
Contact Detail:
CTI Clinical Trial and Consulting Services Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land RASSU Coordinator
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and role thoroughly. Understand their values and how your skills align with what they need. This will help you stand out and show that you're genuinely interested.
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or family to get comfortable with common questions. The more you practice, the more confident you'll feel when it’s your turn in the hot seat.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take the initiative to follow our process.
We think you need these skills to ace RASSU Coordinator
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the RASSU Coordinator role. Highlight any relevant experience in regulatory affairs or clinical trials, and don’t forget to showcase your organisational skills and attention to detail!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about the role and how your background fits perfectly with what we’re looking for. Keep it concise but impactful!
Show Off Your Skills: We want to see your proficiency in Microsoft tools and your understanding of medical terminology. Mention specific examples where you've used these skills effectively in past roles or projects.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way to ensure your application gets to us directly. Plus, it shows you’re serious about joining our team at CTI Clinical Trial and Consulting Services.
How to prepare for a job interview at CTI Clinical Trial and Consulting Services
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of regulatory affairs and clinical trial processes. Familiarise yourself with the specific requirements for submissions in the UK and other regions, as this will show that you're serious about the role and understand what’s needed.
✨Show Off Your Organisational Skills
Since the RASSU Coordinator role involves managing multiple documents and tasks, be ready to discuss how you stay organised. Bring examples of how you've successfully managed projects or documents in the past, and maybe even mention any tools you use to keep everything in check.
✨Communicate Clearly
Excellent verbal and written communication skills are a must for this position. During the interview, practice articulating your thoughts clearly and concisely. You might even want to prepare a few questions to ask them, showing that you’re engaged and interested in the conversation.
✨Be Ready to Discuss Teamwork
This role requires collaboration with various teams and stakeholders. Think of examples from your past experiences where you worked effectively in a team setting. Highlight your interpersonal skills and how you can contribute positively to the RASSU team dynamic.
