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- Tasks: Lead study start-up activities and manage regulatory submissions for clinical trials.
- Company: Join a global, innovative organisation dedicated to impactful clinical research.
- Benefits: Enjoy a hybrid work model and opportunities for career progression.
- Why this job: Make a real impact on life-changing research while collaborating with a passionate team.
- Qualifications: Minimum 3 years in clinical research with experience in UK regulatory submissions required.
- Other info: Position based in Uxbridge; must be within commuting distance.
The predicted salary is between 36000 - 60000 £ per year.
Are you an experienced clinical research professional with a passion for start-up activities and regulatory submissions? We are hiring a Study Start-Up Specialist for a sponsor-dedicated role, offering the opportunity to work on impactful studies while being part of a global, innovative organization.
This is a hybrid role, with 50% of your time spent onsite in Uxbridge, so candidates must be based within a commutable distance.
In this position, you\’ll be fully integrated into the sponsor’s clinical operations team, playing a pivotal role in initiating and supporting clinical trials across the UK.
Key Responsibilities:
- Lead and coordinate all aspects of study start-up, from site identification to activation.
- Manage Health Authority and Ethics Committee submissions (including substantial amendments).
- Ensure completeness of Essential Documents and oversee regulatory documentation within the eTMF.
- Support the preparation and review of Informed Consent Forms (ICFs) and Clinical Trial Package (CTP) documentation.
- Collaborate with internal study teams, site staff, IRBs/ECs, and other stakeholders to meet trial timelines.
- Contribute to feasibility and site selection processes.
- Ensure compliance with ICH-GCP, local regulatory requirements, and sponsor SOPs.
- Support inspection readiness and participate in audit/inspection activities when required.
What You Bring:
- Minimum 3 years of industry experience in clinical research, including start-up activities.
- Prior experience with Health Authority and Ethics Committee submissions in the UK.
- Knowledge or experience with contract negotiation processes is desirable.
- Strong understanding of GCP/ICH Guidelines and the UK regulatory environment.
- Excellent organizational and planning skills, with the ability to manage multiple priorities.
- Demonstrated ability to work independently and within cross-functional teams.
- Proficient in critical thinking, risk analysis, and problem-solving.
- Effective communication skills with internal and external stakeholders.
- Detail-oriented with a focus on quality and compliance.
Why Apply?
- Work directly with a top-tier sponsor on meaningful clinical trials.
- Enjoy a hybrid model – 50% based in a collaborative, modern office in Uxbridge.
- Be part of a dedicated, professional team with opportunities for career progression.
- Make a real impact by contributing to life-changing research and trial delivery.
Ready to make your next move in clinical research?
Apply now to join a passionate team where your expertise drives innovation and improves lives.
Learn more about our EEO & Accommodations request here. #J-18808-Ljbffr
Study Start-Up Specialist (Uxbridge) employer: Fortrea
Contact Detail:
Fortrea Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Study Start-Up Specialist (Uxbridge)
✨Tip Number 1
Network with professionals in the clinical research field, especially those who have experience in study start-up activities. Attend industry events or webinars to connect with potential colleagues and learn about their experiences at similar organisations.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements and submission processes in the UK. This knowledge will not only boost your confidence but also demonstrate your commitment and expertise during interviews.
✨Tip Number 3
Prepare to discuss your previous experiences with Health Authority and Ethics Committee submissions. Be ready to share specific examples of challenges you faced and how you overcame them, as this will showcase your problem-solving skills.
✨Tip Number 4
Highlight your organisational and planning skills by discussing how you've managed multiple priorities in past roles. Use concrete examples to illustrate your ability to keep projects on track and meet deadlines, which is crucial for a Study Start-Up Specialist.
We think you need these skills to ace Study Start-Up Specialist (Uxbridge)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical research, particularly focusing on start-up activities and regulatory submissions. Use keywords from the job description to demonstrate your fit for the role.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for clinical trials and your specific experience with Health Authority and Ethics Committee submissions. Mention how your skills align with the responsibilities outlined in the job description.
Highlight Relevant Skills: In your application, emphasise your organisational skills, ability to manage multiple priorities, and experience working independently and within teams. These are crucial for the Study Start-Up Specialist role.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or typos. A polished application reflects attention to detail, which is essential in clinical research.
How to prepare for a job interview at Fortrea
✨Showcase Your Clinical Research Experience
Be prepared to discuss your previous roles in clinical research, particularly focusing on start-up activities. Highlight specific projects where you led or contributed significantly to study start-up processes, as this will demonstrate your relevant experience.
✨Understand Regulatory Submissions
Familiarise yourself with the Health Authority and Ethics Committee submission processes in the UK. Be ready to explain your experience with these submissions and how you ensure compliance with local regulations and ICH-GCP guidelines.
✨Demonstrate Organisational Skills
Since the role requires managing multiple priorities, prepare examples that showcase your organisational and planning skills. Discuss how you prioritise tasks and manage timelines effectively to meet trial deadlines.
✨Communicate Effectively
Effective communication is key in this role. Practice articulating your thoughts clearly and concisely, especially when discussing complex topics like regulatory documentation or collaboration with stakeholders. This will help convey your ability to work within cross-functional teams.