At a Glance
- Tasks: Coordinate site start-up activities and manage essential documents for clinical trials.
- Company: Fortrea, a leader in accelerating clinical research and ensuring compliance.
- Benefits: Competitive salary, flexible work options, and professional growth opportunities.
- Other info: Join a collaborative team and enjoy a dynamic work environment.
- Why this job: Make a real impact on innovative medications and shape the future of clinical research.
- Qualifications: Degree in life sciences or related field, with 2 years of clinical research experience.
The predicted salary is between 35000 - 45000 £ per year.
Join Our Team and Drive Clinical Research Success. Fortrea is committed to accelerating clinical trials and ensuring regulatory compliance. As a Site Start-Up Specialist, you will coordinate site start-up activities, manage essential documents, and ensure regulatory submissions are completed efficiently. You will be part of the FSPx team and work with key sponsors to advance the development of innovative medications.
Key Responsibilities
- 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 Party/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
- 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. Applications are reviewed on a rolling basis—don’t miss this opportunity!
Site Start-Up Specialist employer: Fortrea
Fortrea is an exceptional employer that prioritises the growth and development of its employees while fostering a collaborative and innovative work culture. As a Site Start-Up Specialist, you will enjoy competitive salaries, flexible work arrangements, and the chance to contribute to groundbreaking clinical research projects, all within a supportive environment that encourages mentorship and professional advancement.
StudySmarter Expert Advice🤫
We think this is how you could land Site Start-Up Specialist
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Fortrea. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Fortrea.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Fortrea. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Fortrea is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Site Start-Up Specialist
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Fortrea!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Fortrea that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Fortrea!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Fortrea, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Fortrea
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Fortrea that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Fortrea’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
