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- Tasks: Lead study start-up and regulatory activities for impactful clinical trials.
- Company: Kapadi, a pioneering CRO focused on innovative oncology research.
- Benefits: Home-based role with competitive salary and opportunities for professional growth.
- Other info: Join a dynamic team dedicated to life-changing therapies for cancer patients.
- Why this job: Make a difference in cancer research while working with cutting-edge technology.
- Qualifications: Bachelor’s degree in Life Sciences and 3+ years in clinical R&D required.
The predicted salary is between 36000 - 60000 £ per year.
Kapadi is a full service CRO that focuses on complex oncology indications including immunotherapy and cellular therapies. We know that innovative research requires innovative operations and we have built that into our culture, systems and processes. We have an infrastructure to enhance access to patients and integrated technology to provide higher quality and faster access to results.
As a Clinical Research Associate II - Study Start-Up and Maintenance, you will:
- Perform study startup and regulatory document maintenance activities for Phase I-IV clinical research projects.
- Assess the progress of clinical projects at assigned sites and ensure clinical projects are conducted, recorded and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and/or all applicable local and federal regulatory requirements.
- Serve as the primary liaison between site and project team throughout the study lifecycle, from site identification through close-out related to site start-up support and regulatory document maintenance. Respond to site concerns and questions as applicable.
- Document activities via communication logs and other required project documents as per SOPs and project plans.
- Enter data into tracking systems as required to track all observations, ongoing status and assigned action items for resolution.
- Manage, coordinate and perform Central IRB submissions for North America and local CTIS submissions for Europe, including but not limited to: initial submissions, amendment submission, changes of PIs, safety submission, annual reviews etc.
- Assist the project team with the creation and finalization of the Clinical Site Activation Plan.
- Routinely mentor junior level team members.
Knowledge, skills and abilities:
- Demonstrated knowledge of the clinical research and development process in pharmaceutical and/or biotechnology industries.
- Demonstrated ability to lead and coordinate study start-up and regulatory activities for large-scale clinical trials.
- Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
Requirements:
- Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.
- Minimum of 3 years of experience in clinical R&D in pharmaceutical, biotechnology and/or clinical research organization (CRO) businesses, including at least 2 years of experience in a CRO providing clinical research services to pharmaceutical, biotechnology or medical device companies.
- 5+ years of experience in a study start-up position.
- Candidates who also bring in experience in compiling EU CTR submissions via CTIS in Ireland or even other EU CTR countries and with additional language skills are preferred.
This position is homebased!
Clinical Research Associate II - Study Start-Up and Maintenance in Nottingham employer: Kapadi
Contact Detail:
Kapadi Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Research Associate II - Study Start-Up and Maintenance in Nottingham
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field, especially those who have experience with CROs. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ICH-GCP guidelines and regulatory requirements. We want you to shine when discussing your experience with study start-up and maintenance!
✨Tip Number 3
Showcase your mentoring skills! If you've trained junior team members, be sure to highlight this during interviews. It shows leadership potential, which is a big plus for us at Kapadi.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Clinical Research Associate II - Study Start-Up and Maintenance in Nottingham
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Clinical Research Associate II role. Highlight your experience in study start-up and regulatory activities, and don’t forget to mention any specific oncology or immunotherapy projects you've worked on!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about clinical research and how your skills align with our mission at Kapadi. Be sure to mention your familiarity with ICH-GCP guidelines and any relevant experiences.
Showcase Your Communication Skills: As a liaison between sites and project teams, strong communication is key. In your application, provide examples of how you've effectively managed stakeholder relationships or resolved site concerns in past roles.
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of getting noticed. It’s the easiest way for us to keep track of your application and ensure it reaches the right people!
How to prepare for a job interview at Kapadi
✨Know Your Stuff
Make sure you brush up on your knowledge of clinical research processes, especially around study start-up and regulatory activities. Familiarise yourself with ICH-GCP guidelines and any specific regulations that apply to the role. This will not only help you answer questions confidently but also show your genuine interest in the field.
✨Showcase Your Experience
Prepare to discuss your previous roles in clinical research, particularly any experience you have with Phase I-IV trials. Be ready to share specific examples of how you've managed study start-up activities or mentored junior team members. This will demonstrate your capability and readiness for the responsibilities of the position.
✨Ask Insightful Questions
Interviews are a two-way street! Prepare thoughtful questions about Kapadi's approach to oncology research and their use of integrated technology. This shows that you're not just interested in the job, but also in how you can contribute to their innovative culture.
✨Be Ready for Scenario-Based Questions
Expect to face scenario-based questions that assess your problem-solving skills and ability to handle site concerns. Think of past experiences where you successfully navigated challenges in clinical trials and be prepared to discuss your thought process and outcomes.