At a Glance
- Tasks: Monitor clinical trials, ensuring compliance and quality across diverse sites.
- Company: TMC, a leader in rare diseases and oncology research.
- Benefits: Remote work with travel opportunities and a supportive team environment.
- Other info: Flexible role with career growth in a dynamic field.
- Why this job: Make a real difference in healthcare by managing impactful clinical trials.
- Qualifications: 4-5 years of monitoring experience and knowledge of GCP/ICH guidelines.
The predicted salary is between 46000 - 52000 £ per year.
Due to expansion, TMC are looking to hire a UK based experienced Senior CRA. As our specialisms are Rare and Orphan diseases and Oncology, experience in these areas is essential to the successful candidate.
Responsibilities
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) E6 R3 and International Conference on Harmonization (ICH) guidelines.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (eTMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
Requirements
- A minimum of 4-5 years of independent on-site monitoring.
- You have successfully managed multiple clinical trial protocols across diverse investigative sites.
- In depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Life science degree.
- Flexibility to travel to sites.
- A range of therapeutic area experience including oncology and rare and orphan diseases.
- Whilst the role is remote based, we will expect regular visits to the Head Office in Hartley Wintney, Hampshire.
- A driving licence is essential.
*Please note - this role is not eligible for UK visa sponsorship*
Senior Clinical Research Associate in Hull employer: TMC Pharma Services Ltd
TMC is an exceptional employer for Senior Clinical Research Associates, offering a dynamic work culture that prioritises collaboration and innovation in the fields of Rare and Orphan diseases and Oncology. With a strong commitment to employee growth, TMC provides ongoing training and development opportunities, alongside the flexibility of remote work complemented by regular engagement at our Hartley Wintney office, ensuring a supportive environment for professional advancement.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Clinical Research Associate in Hull
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field, especially those with experience in oncology and rare diseases. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on GCP and ICH guidelines. We all know that knowledge is power, so make sure you can confidently discuss how you've applied these standards in your previous roles. It’ll show you're the right fit for the Senior CRA position!
✨Tip Number 3
Don’t just wait for job alerts! Regularly check our website for new opportunities and apply directly. This shows initiative and can give you an edge over other candidates who might be waiting for emails.
✨Tip Number 4
Follow up after interviews! A quick thank-you email reiterating your interest in the role can keep you fresh in the interviewer's mind. Plus, it’s a great chance to highlight any key points you might have missed during the chat.
We think you need these skills to ace Senior Clinical Research Associate in Hull
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your experience in rare and orphan diseases and oncology. We want to see how your background aligns with our needs, so don’t be shy about showcasing relevant projects you've worked on!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for the Senior CRA role. Share specific examples of your monitoring experience and how you’ve tackled challenges in previous studies.
Showcase Your GCP Knowledge:Since we’re all about Good Clinical Practice, make sure to mention your familiarity with GCP E6 R3 and ICH guidelines. We love candidates who can demonstrate their understanding of these standards in their application.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at TMC Pharma Services Ltd
✨Know Your GCP and ICH Guidelines
Make sure you brush up on Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines before the interview. Being able to discuss these in detail will show that you’re not just familiar with them, but that you truly understand their importance in clinical research.
✨Showcase Your Monitoring Experience
Prepare specific examples from your past roles where you successfully managed multiple clinical trial protocols. Highlight your experience with site monitoring visits and how you’ve tackled challenges in recruitment or compliance. This will demonstrate your hands-on expertise and problem-solving skills.
✨Communicate Effectively
Since the role involves liaising with various stakeholders, practice articulating your thoughts clearly and concisely. Think about how you can convey complex information simply, as this will be crucial when training site staff or discussing project expectations.
✨Be Ready to Discuss Flexibility
As the role requires travel to sites and regular visits to the Head Office, be prepared to discuss your flexibility and willingness to adapt. Share any previous experiences where you had to adjust your schedule or approach to meet project needs, showing that you’re committed to the role.
