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- Tasks: Manage study start-up and regulatory activities for impactful clinical research projects.
- Company: Join a leading CRO focused on innovative oncology therapies.
- Benefits: Competitive salary, flexible work options, and opportunities for professional growth.
- Why this job: Make a difference in cancer research and help deliver life-changing therapies.
- Qualifications: Bachelor’s degree in Life Sciences and 3 years of clinical research experience.
- 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 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 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 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.
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 research.
Research Associate II - Study Start-Up and Maintenance 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
✨Tip Number 1
Network like a pro! Reach out to professionals in the clinical research field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by practising common questions and scenarios related to study start-up and maintenance. We recommend doing mock interviews with friends or mentors to boost your confidence and refine your answers.
✨Tip Number 3
Showcase your skills! Create a portfolio or a presentation that highlights your experience in managing clinical trials and regulatory activities. This will help you stand out and demonstrate your expertise to potential employers.
✨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 Research Associate II - Study Start-Up and Maintenance
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 document maintenance, as well as any relevant skills that match our needs at Kapadi.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're passionate about clinical research and how your background aligns with our mission. Be sure to mention specific experiences that demonstrate your knowledge of ICH-GCP and regulatory requirements.
Showcase Your Communication Skills: As a liaison between sites and project teams, strong communication is key. Use your application to showcase examples where you've effectively communicated complex information or resolved site concerns.
Apply Through Our Website: We encourage you to apply directly through our website. This ensures your application gets to the right people and shows us you're serious about joining our team at Kapadi!
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 oncology. Familiarise yourself with Good Clinical Practice (GCP) and ICH guidelines, as these will likely come up during the interview. Being able to discuss specific examples from your experience will show that you’re not just knowledgeable but also practical.
✨Show Your Coordination Skills
Since this role involves a lot of coordination between sites and project teams, be prepared to share examples of how you've successfully managed similar tasks in the past. Highlight any experience you have with study start-up activities and regulatory document maintenance, as this will demonstrate your capability to handle the responsibilities of the position.
✨Ask Insightful Questions
Interviews are a two-way street! Prepare some thoughtful questions about the company’s approach to innovative research and how they support their teams. This shows your genuine interest in the role and helps you gauge if the company culture aligns with your values.
✨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 situations where you had to troubleshoot issues or manage conflicts, and be ready to explain your thought process and the outcomes. This will help the interviewers see how you think on your feet.
