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- Tasks: Join our team to ensure clinical trials are conducted with integrity and quality.
- Company: Rho, an award-winning CRO with a dynamic and collaborative culture.
- Benefits: Permanent home-based role with opportunities for professional growth.
- Why this job: Make a real impact in healthcare while advancing your career in clinical research.
- Qualifications: Bachelor's degree in life sciences or equivalent experience in clinical monitoring.
- Other info: Be part of a passionate team dedicated to solving humanity's biggest challenges.
The predicted salary is between 36000 - 60000 £ per year.
Rho, an award-winning, stable, full-service CRO known for its collaborative, dynamic culture based in the US, is quickly expanding their presence in Europe. We are a thriving company, delivering global full-service clinical development services and unmatched customer support worldwide.
As a Clinical Research Associate II / Sr. CRA, you will be a key player in our innovative team, dedicated to ensuring that our clinical trials are conducted with the utmost integrity and quality. Your expertise will help us navigate the complexities of clinical research as we strive to deliver meaningful solutions to healthcare challenges.
The Clinical Monitoring team at Rho is known for its collaborative spirit and commitment to excellence. Join us to advance your career and contribute to a culture that celebrates innovation, supports professional growth, and values every team member's input. This is a permanent home-based role in the UK.
Responsibilities:
- May contribute to the development of study tools and materials as well as documentation for clinical trials.
- May provide mentoring, training, and co-monitoring of junior CRAs and other clinical team members.
- May provide support to the RFP process.
- Prepare and perform all onsite & off-site/remote site monitoring visit activities across multiple protocols, inclusive of all study visit types as needed (SQV, SIV, IMV and COV), according to Good Clinical Practice (GCP), Protocol, applicable regulations and Sponsor requirements under supervision of experienced staff.
- Effectively document observations in site visit reports and follow-up letters within timelines required by Rho's procedural documents and the applicable clinical monitoring plan.
- Prepare (if needed) and maintain Investigator Site Files (ISF), and maintain site binders and documents of the TMF (Trial Master File).
- May assist in payment processes, including liaison with Site and review Site and patient data for visits being invoiced.
- Assist in the appropriate identification and action of AE (Adverse Event), SAEs (Serious Adverse Event) and pregnancy reporting procedure.
- Verify and confirm appropriate IMP (Investigational Medicinal Product) handling at Site and perform drug accountability.
- Help to plan and perform Country and Site Feasibility, including assessment of potential Risks and challenges, as well as select Study sites and perform pre-study visits.
- Assist in selection of Study specific Vendors and perform Vendor assessments.
- Support in negotiation and execution of Investigator/ Institution contracts.
- May help to prepare documents submission to Ethics Committee, Competent Authorities and other bodies (as applicable), including communication with Sponsor, EC/ CA and other involved parties.
- Senior CRAs may provide mentoring, training, and co-monitoring of junior CRAs and other clinical team members.
- May support Clinical Team Lead and Project Management tasks on assigned studies as requested (e.g. study specific process development, trip report review, newsletter creation, leading CRA project team calls, etc.).
- May conduct sign-off visits to assess competency of other CRAs.
- May attend and present at meetings and conferences, including Investigator Meetings.
- May participate in the interview and selection process for CRAs.
Qualifications:
- Bachelor's degree, preferably in a life science, nursing, pharmacy, or related science field.
- Registered Nursing certification or equivalent or relevant formal academic/vocational qualification (such as LPN) combined with a minimum of 2 years of clinical monitoring experience and demonstrated clinical monitoring knowledge may be considered in lieu of a Bachelor's degree.
- 2 years of on-site monitoring experience within the CRO, pharmaceutical or biotechnology industry.
- Fluent in English and local language.
- Proficient knowledge of ICH-GCP and country specific clinical monitoring guidelines.
- Proven clinical monitoring skills.
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology in areas of experience.
- Average travel is expected to be 80%. Ability to travel domestically and internationally as needed.
Clinical Research Associate II / Sr. CRA, United Kingdom in London employer: Rho, Inc.
Contact Detail:
Rho, Inc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Research Associate II / Sr. CRA, United Kingdom in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field, attend industry events, and join relevant online groups. The more people you know, the better your chances of landing that CRA role at Rho.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ICH-GCP guidelines and the latest trends in clinical research. Show us that you're not just a candidate, but a passionate individual ready to make a difference in healthcare.
✨Tip Number 3
Don’t forget to showcase your mentoring skills! If you've trained or supported junior CRAs before, highlight those experiences. Rho values collaboration, so let’s show them how you can contribute to their dynamic culture.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows us that you’re genuinely interested in being part of the Rho team and contributing to our mission in clinical research.
We think you need these skills to ace Clinical Research Associate II / Sr. CRA, United Kingdom in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Clinical Research Associate role. Highlight relevant experience, especially in clinical monitoring and any specific skills that match the job description. We want to see how your background aligns with our mission at Rho!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to express your passion for clinical research and why you want to join Rho. Share specific examples of your achievements and how they relate to the responsibilities outlined in the job description.
Showcase Your Team Spirit: At Rho, collaboration is key! In your application, mention experiences where you've worked effectively in a team. We love seeing candidates who value teamwork and can contribute to our dynamic culture.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you're serious about joining our innovative team at Rho!
How to prepare for a job interview at Rho, Inc.
✨Know Your Stuff
Make sure you brush up on your knowledge of ICH-GCP and the specific clinical monitoring guidelines relevant to the UK. Rho values integrity and quality, so being able to discuss these topics confidently will show that you're serious about the role.
✨Show Your Collaborative Spirit
Since Rho prides itself on a collaborative culture, be prepared to share examples of how you've worked effectively in teams. Highlight any mentoring or training experiences you've had, as this aligns perfectly with the responsibilities of the role.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about challenges you've faced in previous roles, especially related to site monitoring or managing adverse events, and be ready to explain how you handled them.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions. Inquire about Rho's approach to professional growth or how they support their CRAs in navigating complex clinical trials. This shows your genuine interest in the company and the role.
