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- Tasks: Lead site monitoring for ophthalmology trials, ensuring compliance and quality.
- Company: TFS HealthScience is a global CRO focused on innovative therapies in clinical development.
- Benefits: Enjoy flexible remote work and be part of a passionate team making a difference.
- Why this job: Join cutting-edge research in ophthalmology and contribute to impactful gene therapy studies.
- Qualifications: Experience in clinical trial monitoring and ophthalmology required; gene therapy knowledge is a plus.
- Other info: This is a freelance role, approximately 0.25 FTE, offering flexibility.
The predicted salary is between 36000 - 60000 £ per year.
TFS HealthScience is a global, mid-sized Contract Research Organization (CRO) dedicated to supporting biotechnology and pharmaceutical companies throughout their clinical development journey. We provide full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions to help bring innovative therapies to patients worldwide.
We are currently seeking a Freelance Senior Clinical Research Associate (SCRA) with strong ophthalmology experience, particularly in retinal disorders, based in the UK. This role involves working with a key sponsor on gene therapy and retinal disease studies, ensuring high-quality execution, regulatory compliance, and effective risk-based monitoring. Please, keep in mind that this is a Freelance role for approximately 0.25 FTE.
Key Responsibilities:- Lead site monitoring activities for ophthalmology trials, ensuring adherence to protocol, GCP, and regulatory requirements.
- Implement risk-based approaches to ensure proactive issue resolution and maintain trial quality.
- Manage ethics committee submissions, amendments, and periodic regulatory reporting, including safety event notifications.
- Contribute to site activation, including Site Initiation Visits (SIVs) and investigator training.
- Ensure proper trial documentation, monitor data integrity, and support study closeout.
- Prior experience in clinical trial monitoring within a CRO, biotech, or pharmaceutical company.
- At least 1 year of therapeutic expertise in ophthalmology trials.
- Experience in retinal disorders.
- Gene therapy experience is a plus but not required.
- Familiarity with local and international regulatory requirements.
- Strong interpersonal skills to engage effectively with sponsors and site staff.
Join us in driving forward cutting-edge clinical research in ophthalmology and beyond.
TFS HealthScience: Senior Clinical Research Associate employer: Lisebleijs
Contact Detail:
Lisebleijs Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land TFS HealthScience: Senior Clinical Research Associate
✨Tip Number 1
Network with professionals in the ophthalmology field, especially those who have experience in clinical trials. Attend relevant conferences or webinars to connect with potential colleagues and learn about the latest trends in retinal disorders.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements for clinical trials in the UK, particularly those related to ophthalmology. This knowledge will not only boost your confidence but also demonstrate your commitment to compliance during interviews.
✨Tip Number 3
Prepare to discuss your previous experiences in clinical trial monitoring, focusing on any challenges you faced and how you overcame them. Highlighting your problem-solving skills will show that you're ready for the proactive issue resolution required in this role.
✨Tip Number 4
Research TFS HealthScience's recent projects and publications in gene therapy and retinal diseases. Being knowledgeable about their work will help you engage in meaningful conversations during interviews and show your genuine interest in joining their team.
We think you need these skills to ace TFS HealthScience: Senior Clinical Research Associate
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in clinical trial monitoring, particularly in ophthalmology and retinal disorders. Use specific examples to demonstrate your expertise and achievements in these areas.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also expresses your passion for clinical research and the impact of gene therapy on retinal diseases. Mention why you are interested in working with TFS HealthScience specifically.
Highlight Regulatory Knowledge: Emphasise your familiarity with local and international regulatory requirements in your application. This is crucial for the role, so provide examples of how you've ensured compliance in past projects.
Showcase Interpersonal Skills: Since the role involves engaging with sponsors and site staff, include examples in your application that demonstrate your strong interpersonal skills and ability to work collaboratively in a team environment.
How to prepare for a job interview at Lisebleijs
✨Showcase Your Ophthalmology Expertise
Make sure to highlight your experience in ophthalmology, especially with retinal disorders. Be prepared to discuss specific trials you've worked on and how your contributions led to successful outcomes.
✨Understand Regulatory Requirements
Familiarise yourself with both local and international regulatory requirements relevant to clinical trials. Demonstrating your knowledge in this area will show that you can ensure compliance and maintain high-quality standards.
✨Emphasise Interpersonal Skills
Since the role involves engaging with sponsors and site staff, be ready to discuss examples of how you've effectively communicated and built relationships in previous roles. Strong interpersonal skills are crucial for success in this position.
✨Prepare for Risk-Based Monitoring Discussions
Be prepared to talk about your approach to risk-based monitoring. Share any experiences where you proactively identified issues and implemented solutions to maintain trial quality, as this is a key responsibility of the role.
