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- 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, competitive pay, and opportunities for professional growth.
- Why this job: Be part of impactful clinical trials that contribute to healthcare advancements.
- Qualifications: Bachelor's degree in health-related fields and strong communication skills required.
- Other info: Dynamic team environment with training opportunities and career development.
The predicted salary is between 28800 - 43200 £ 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 in London 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 in London
✨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. 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 in the position.
✨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, it shows you’re serious about joining our team at CTI Clinical Trial and Consulting Services.
We think you need these skills to ace RASSU Coordinator in London
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the RASSU Coordinator role. Highlight any relevant experience in regulatory affairs or clinical trials, and don’t forget to mention your proficiency with Microsoft tools!
Show Off Your Skills: We want to see your excellent communication skills shine through! Use clear and concise language in your application, and make sure to demonstrate your organisational abilities and attention to detail.
Follow the Instructions: Remember to apply through our website or verified LinkedIn page only. We won’t reach out via Teams or text, so stick to the official channels to ensure your application is seen by the right people.
Keep It Professional: While we love a friendly tone, keep your application professional. Proofread for any typos or errors, and ensure that your documents are formatted neatly. A polished application speaks volumes about your attention to detail!
How to prepare for a job interview at CTI Clinical Trial and Consulting Services
✨Know Your Regulatory Affairs Basics
Before the interview, brush up on your knowledge of regulatory affairs and clinical trial processes. Familiarise yourself with key terminology and the specific requirements for submissions in the UK and other regions. This will show that you’re not just interested in the role but also understand its core responsibilities.
✨Showcase Your Organisational Skills
Since the RASSU Coordinator role involves managing multiple documents and tasks, be prepared to discuss how you stay organised. Bring examples of tools or methods you use to keep track of projects, like spreadsheets or project management software. This will demonstrate your ability to handle the demands of the position.
✨Prepare for Team Collaboration Questions
Expect questions about teamwork and collaboration, as this role requires coordination with local study teams and external vendors. Think of specific instances where you successfully worked with others to achieve a goal, and be ready to share those stories during the interview.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about the team dynamics, ongoing projects, or how success is measured in the role. This shows your genuine interest in the position and helps you gauge if it’s the right fit for you.
