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- Tasks: Manage study start-up and regulatory activities for impactful clinical research projects.
- Company: Join Kapadi, a leading CRO focused on innovative oncology therapies.
- Benefits: Home-based role with competitive salary and opportunities for professional growth.
- 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.
- Other info: Dynamic team environment with a focus on innovation and patient access.
The predicted salary is between 36000 - 60000 £ per year.
This is not an on-site or in-house monitoring position. This role is equivalent to an SSU Specialist II. 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’ve 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.
We are looking for a highly-motivated Research Associate II - Study Start-Up and Maintenance to help us continue to grow our business and deliver new, life-changing therapies for the cancer patients who need them.
As a 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 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.
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!
Research Associate II - Study Start-Up and Maintenance in London employer: Kapadi
Contact Detail:
Kapadi Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Research Associate II - Study Start-Up and Maintenance in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field, especially those who have experience with study start-up and maintenance. 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 Good Clinical Practice and ICH guidelines. We want you to shine when discussing your experience in managing regulatory activities and site coordination.
✨Tip Number 3
Showcase your problem-solving skills! Be ready to share examples of how you've tackled challenges in previous roles, especially in study start-up processes. This will demonstrate your ability to handle the complexities of clinical trials.
✨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 genuinely interested in joining our mission to deliver life-changing therapies.
We think you need these skills to ace Research Associate II - Study Start-Up and Maintenance in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Research Associate II role. Highlight your experience in study start-up and regulatory activities, and don’t forget to mention any specific oncology or clinical research experience you have!
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 and regulatory requirements.
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 site concerns or coordinated with teams in past roles.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Kapadi
✨Know Your Stuff
Make sure you brush up on your knowledge of the clinical research process, especially in relation to oncology and regulatory requirements. Familiarise yourself with ICH-GCP guidelines and be ready to discuss how you've applied these in your previous roles.
✨Showcase Your Experience
Prepare specific examples from your past work that highlight your experience in study start-up and maintenance. Be ready to talk about how you've managed IRB submissions and coordinated with project teams, as this will demonstrate your hands-on expertise.
✨Be a Problem Solver
Think of scenarios where you faced challenges during a study start-up and how you resolved them. This role requires you to be the primary liaison, so showcasing your ability to handle site concerns effectively will set you apart.
✨Ask Smart Questions
Prepare thoughtful questions about the company's approach to innovative research and how they integrate technology into their processes. This shows your genuine interest in the role and helps you understand if the company culture aligns with your values.
