At a Glance
- 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.
We are looking for a highly-motivated Clinical 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 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 Colchester employer: Kapadi
Kapadi is an exceptional employer that fosters a culture of innovation and collaboration, particularly in the dynamic field of oncology research. With a strong commitment to employee growth, we offer comprehensive training and mentorship opportunities, ensuring that our Clinical Research Associates thrive in their roles while contributing to life-changing therapies for cancer patients. Our home-based work model provides flexibility, allowing you to balance your professional and personal life effectively, all while being part of a forward-thinking team dedicated to making a real impact in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Research Associate II - Study Start-Up and Maintenance in Colchester
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field, especially those who work at CROs. A friendly chat can lead to insider info about job openings and even referrals.
✨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 in conversations. It shows leadership and a commitment to team success, which is super valuable in our industry.
✨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 Clinical Research Associate II - Study Start-Up and Maintenance in Colchester
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 and 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 show that you're not just interested in the job, but that you understand the industry.
✨Showcase Your Experience
Prepare to discuss your previous roles in clinical research, particularly your experience 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 help demonstrate your capability and fit for the position.
✨Ask Smart Questions
Come prepared with insightful questions about the company's operations, especially regarding their approach to oncology and innovative therapies. This shows your genuine interest in the role and helps you gauge if the company culture aligns with your values.
✨Be Ready to Discuss Challenges
Think about challenges you've faced in previous roles, particularly in managing site concerns or regulatory submissions. Be prepared to explain how you overcame these obstacles, as this will highlight your problem-solving skills and resilience in a fast-paced environment.
