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- Tasks: Coordinate site start-up activities and manage essential regulatory documents.
- Company: Fortrea accelerates clinical trials to bring life-changing treatments to patients.
- Benefits: Enjoy competitive salary, flexible work options, and professional growth opportunities.
- Why this job: Be part of innovative projects that shape the future of clinical research.
- Qualifications: University degree or certification in health; 2 years in clinical research required.
- Other info: Applications are reviewed on a rolling basis—apply now!
The predicted salary is between 36000 - 60000 £ per year.
Join Our Team and Drive Clinical Research Success!
At Fortrea , we are committed to accelerating clinical trials and ensuring regulatory compliance. As a Site Start-Up Specialist, you will play a pivotal role in coordinating site start-up activities, managing essential documents, and ensuring regulatory submissions are completed efficiently. Your expertise will help bring life-changing treatments to patients faster.
In this role, you will be part of our FSPx team and work directly with one of our renowned key sponsor to advance the development of innovative, life-changing medications.
Key Responsibilities:
In this role, you will:
- Serve as the primary contact for investigative sites during start-up and maintenance activities.
- Collect, review, and organize essential documents required for regulatory submissions (EC/IRB/Third Body/Regulatory Authority).
- Ensure compliance with ICH/GCP guidelines, regulatory requirements, and sponsor specifications.
- Prepare and submit regulatory documents, including country-specific application forms and informed consent forms.
- Track submission timelines and proactively address potential delays.
- Collaborate with internal and external stakeholders, including vendors, clinical teams, and regulatory authorities.
- Ensure all documentation is audit-ready and systems are consistently updated.
- Assist in the negotiation of site contracts and budgets, if applicable.
- Provide mentorship and training to new hires and less-experienced colleagues.
Required Qualifications:
To succeed in this role, you should have:
- University/College degree (life sciences preferred) or certification in a related allied health profession.
- Minimum 2 years of experience in clinical research, regulatory submissions, or site activation.
- Strong knowledge of ICH/GCP guidelines, RA, IRB/IEC regulations, and start-up processes.
- Ability to review and adapt patient informed consent forms to meet local and protocol-specific requirements.
- Experience interacting with regulatory authorities and site start-up teams.
- Excellent organizational, problem-solving, and communication skills.
- Proficiency in Microsoft Office and document management systems.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
What We Offer:
- Competitive salary and performance-based incentives.
- Flexible work arrangements (remote/hybrid options).
- Professional growth opportunities in a collaborative and innovative environment.
- The opportunity to work on cutting-edge clinical research projects.
Ready to Make an Impact?
Join us in shaping the future of clinical research. Apply today!
Applications are reviewed on a rolling basis-don’t miss this opportunity!
#LI-Remote #LI-Hybrid
Learn more about our EEO & Accommodations request here . #J-18808-Ljbffr
Site Start-Up Specialist employer: Fortrea
Contact Detail:
Fortrea Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Site Start-Up Specialist
✨Tip Number 1
Familiarise yourself with ICH/GCP guidelines and regulatory requirements. Understanding these standards will not only help you in interviews but also demonstrate your commitment to compliance, which is crucial for the Site Start-Up Specialist role.
✨Tip Number 2
Network with professionals in the clinical research field. Attend industry events or join relevant online forums to connect with others who may have insights or even job leads related to site start-up activities.
✨Tip Number 3
Prepare to discuss your experience with regulatory submissions and site activation processes in detail. Be ready to share specific examples of how you've successfully managed timelines and addressed challenges in previous roles.
✨Tip Number 4
Showcase your organisational and problem-solving skills during any interactions with us. Whether it's in an interview or a networking event, demonstrating these abilities can set you apart as a strong candidate for the Site Start-Up Specialist position.
We think you need these skills to ace Site Start-Up Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Site Start-Up Specialist position. Understand the key responsibilities and required qualifications to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in clinical research, regulatory submissions, or site activation. Provide specific examples of how you've managed essential documents and ensured compliance with ICH/GCP guidelines.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your passion for clinical research and your ability to drive success in site start-up activities. Mention your familiarity with regulatory authorities and your problem-solving skills.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. A well-presented application reflects your attention to detail, which is crucial for this role.
How to prepare for a job interview at Fortrea
✨Know Your Regulatory Stuff
Make sure you brush up on ICH/GCP guidelines and the specific regulatory requirements relevant to the role. Being able to discuss these confidently will show that you're well-prepared and knowledgeable.
✨Showcase Your Organisational Skills
As a Site Start-Up Specialist, you'll need to manage multiple documents and timelines. Be ready to share examples of how you've successfully organised complex projects in the past.
✨Prepare for Scenario Questions
Expect questions about how you would handle specific challenges in site start-up activities. Think through potential scenarios and how you would address them, demonstrating your problem-solving skills.
✨Highlight Your Communication Skills
You'll be collaborating with various stakeholders, so it's crucial to demonstrate your communication abilities. Prepare to discuss how you've effectively communicated with teams or regulatory authorities in previous roles.
