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: Regular office visits in Hampshire; driving licence essential.
- Why this job: Make a real difference in healthcare by managing impactful clinical trials.
- Qualifications: 4-5 years of monitoring experience and a life science degree required.
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 Newcastle upon Tyne 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 field 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 Head Office in Hartley Wintney, Hampshire. Join us to be part of a team that values your expertise and fosters a supportive environment for meaningful contributions to clinical research.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Clinical Research Associate in Newcastle upon Tyne
✨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 in your previous roles. It’ll show you're the right fit for the Senior CRA position.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and interests. At StudySmarter, we encourage you to check out our website for roles that excite you. Tailor your approach to each company to stand out!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Share a brief insight or question related to your discussion to show your enthusiasm and commitment to the role.
We think you need these skills to ace Senior Clinical Research Associate in Newcastle upon Tyne
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 and achievements!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about clinical research and how your skills make you the perfect fit for the Senior CRA role. We love a good story, so let your personality come through!
Showcase Your Monitoring Experience:Since site monitoring is key for this role, be sure to detail your on-site monitoring experience. We want to know how you've managed studies and tackled challenges in the past, so give us the juicy details!
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’s super easy – just a few clicks and you’re done!
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. 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 Experience
Prepare to talk about your previous roles and how you've managed multiple clinical trial protocols. Use specific examples from your experience in oncology and rare diseases to demonstrate your expertise and how it aligns with the company's focus.
✨Be Ready for Scenario Questions
Expect questions that put you in hypothetical situations related to site monitoring and problem-solving. Think through potential challenges you might face in the role and how you would address them, especially regarding subject recruitment and quality issues.
✨Communicate Effectively
Since this role involves liaising with various stakeholders, practice clear and concise communication. Be prepared to discuss how you establish regular lines of communication with sites and manage ongoing project expectations, as this will be key to your success in the role.
