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 dynamic team environment.
- Other info: Regular office visits required; driving licence essential.
- Why this job: Make a real difference in groundbreaking clinical research while advancing your career.
- 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 Plymouth 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 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 Plymouth
✨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 being able to discuss these topics confidently will show potential employers you’re the real deal.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and interests. When you find a role that excites you, tailor your approach and let your passion shine through during interviews.
✨Tip Number 4
Check out our website for the latest job openings! Applying directly through us not only gives you a better chance but also keeps you in the loop about any upcoming opportunities in the clinical research space.
We think you need these skills to ace Senior Clinical Research Associate in Plymouth
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to highlight your experience in rare and orphan diseases and oncology. We want to see how your background aligns with the specific requirements of the Senior CRA role.
Showcase Your Monitoring Experience:In your application, emphasise your independent on-site monitoring experience. We’re looking for someone who has successfully managed multiple clinical trial protocols, so don’t hold back on those details!
Highlight Your GCP Knowledge:Since knowledge of Good Clinical Practice (GCP) and ICH guidelines is crucial, make sure to mention any relevant training or certifications. We appreciate candidates who are well-versed in these standards.
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 this exciting opportunity!
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 site monitoring visits. Highlight your experience with selection, initiation, and close-out visits, as well as how you tackled any challenges that arose during these processes.
✨Demonstrate Your Flexibility
Since the role requires travel to various sites, be ready to discuss your flexibility and willingness to travel. Share any previous experiences where you adapted to changing schedules or locations, as this will reassure them of your commitment to the role.
✨Communicate Effectively
Effective communication is key in this role. Prepare to discuss how you’ve established lines of communication with study sites in the past. Think about how you’ve managed expectations and resolved issues, as this will highlight your collaborative skills and ability to maintain strong relationships.
