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- Tasks: Join us as a Start-up Specialist to activate clinical trials and manage essential documentation.
- Company: Fortrea is a global leader in clinical research, transforming drug development across 100 countries.
- Benefits: Enjoy a collaborative workspace, personal growth opportunities, and the chance to make a global impact.
- Why this job: Be part of a passionate team dedicated to revolutionising clinical trials and delivering life-changing therapies.
- Qualifications: Bachelor's degree in life sciences and at least 2 years in clinical research required.
- Other info: Fortrea values diversity and inclusion, encouraging all to apply.
The predicted salary is between 36000 - 60000 £ per year.
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Fortrea is currently seeking a proactive Start-up Specialist to join our client-dedicated Team. Are you a detail-oriented professional with experience in clinical research and regulatory processes? Join our team as a Start-up Specialist and play a key role in site activation for clinical trials!
Summary of Responsibilities:
- Serve as a primary contact expert for a dedicated Client, to perform Country Level start-up and maintenance activities/amendments of Clinical Trials in the UK (ROI applications knowledge also useful, but not essential).
- Collaborate effectively to collect, review, prepare and manage all essential documentation necessary for submissions to UK ethics and regulatory authorities.
- Ensure timely and compliant submissions to EC/IRB/Third body (e.g ARSAC)/Regulatory authorities in the relevant systems, predominantly UK Combined Review.
- Maintain knowledge of submission regulatory standards and provide expert guidance on start-up processes.
- Confidently support QC activities of applications before submissions.
- Track submission milestones, meet strict client deadlines and KPIs. Escalate issues and ensure audit readiness.
- Collaborate with project teams, Chief Investigators and mentor junior colleagues as needed.
What We are looking for:
- Education: Bachelor's degree in life sciences or related field (or relevant equivalent experience).
- Experience: At least 2 years in clinical research, with knowledge of ICH guidelines and regulatory requirements. Experience in country set up and maintenance of Oncology Trials is desirable.
- Strong understanding of CT start-up documentation, Country Level start-up and maintenance activities including submission processes and relevant systems within the UK.
- Knowledge of the full functionality of Combined Review processes for both Ethics (SIF) and Regulatory (MIF and Section D) is desirable, although mentoring will be available for candidates with a main expertise in one of these areas.
- Excellent organizational, communication and problem-solving skills.
- Basic knowledge and familiarity with Clinical Trials Information System (CTIS) processes (EU-specific roles), would be useful but not currently essential in this role.
Ready to make a difference? Apply today! Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
Fortrea is proud to be an Equal Opportunity Employer: As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
Start-up Specialist employer: Fortrea
Contact Detail:
Fortrea Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Start-up Specialist
✨Tip Number 1
Familiarise yourself with the UK regulatory landscape, especially the Combined Review processes for Ethics and Regulatory submissions. Understanding these systems will not only boost your confidence but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the clinical research field, particularly those who have experience in start-up activities. Engaging with others can provide valuable insights and may even lead to referrals or recommendations.
✨Tip Number 3
Stay updated on the latest trends and changes in clinical trial regulations and guidelines. This knowledge will help you stand out as a proactive candidate who is ready to tackle challenges in the start-up process.
✨Tip Number 4
Prepare to discuss specific examples from your past experiences that highlight your problem-solving skills and attention to detail. Being able to articulate how you've successfully navigated challenges in previous roles will make a strong impression.
We think you need these skills to ace Start-up Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Start-up Specialist. Familiarise yourself with clinical research processes and regulatory requirements to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in clinical research, particularly any work related to start-up activities and regulatory submissions. Mention specific projects or trials you've been involved in to showcase your expertise.
Showcase Your Skills: Demonstrate your organisational, communication, and problem-solving skills in your application. Provide examples of how you've successfully managed documentation and met deadlines in previous roles.
Tailor Your Application: Customise your CV and cover letter for Fortrea by incorporating keywords from the job description. This shows that you have taken the time to understand what they are looking for and how you can contribute to their team.
How to prepare for a job interview at Fortrea
✨Know Your Regulatory Stuff
Make sure you brush up on ICH guidelines and UK regulatory requirements. Being able to discuss these confidently will show that you're serious about the role and understand the complexities of clinical trials.
✨Demonstrate Your Detail Orientation
As a Start-up Specialist, attention to detail is crucial. Prepare examples from your past experience where your meticulous nature helped in successful submissions or project completions.
✨Showcase Your Collaboration Skills
This role involves working with various teams and stakeholders. Be ready to share instances where you've effectively collaborated with others, especially in high-pressure situations.
✨Prepare for Problem-Solving Questions
Expect questions that assess your problem-solving abilities. Think of specific challenges you've faced in clinical research and how you overcame them, particularly in start-up processes.
