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- Tasks: Monitor clinical trials and ensure compliance with regulations and protocols.
- Company: Join a cutting-edge respiratory biotech company transforming treatment for respiratory diseases.
- Benefits: Enjoy competitive salary, flexible working arrangements, and career growth opportunities.
- Why this job: Be part of groundbreaking research that improves patient outcomes in respiratory health.
- Qualifications: Degree in Life Sciences or related field; 1-3 years CRA experience preferred.
- Other info: Travel within the UK and internationally may be required (up to 50%).
The predicted salary is between 36000 - 60000 £ per year.
Job Title: Clinical Research Associate (CRA)
Location: United Kingdom
Company: Biotech
Location: Midlands & North-East UK
About Us
Our Biotech Partner is a cutting-edge respiratory biotech company focused on developing innovative therapies to transform the treatment of respiratory diseases. We are committed to improving patient outcomes through groundbreaking research and clinical development. As we continue to expand, we are seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to join our team and contribute to our mission.
Job Summary
The Clinical Research Associate (CRA) will be responsible for monitoring clinical trials to ensure they are conducted in compliance with regulatory standards, protocols, and company procedures. This individual will work closely with investigators, clinical sites, and the internal clinical operations team to ensure the successful execution of trials, with a particular focus on respiratory therapeutic areas.
Key Responsibilities
Clinical Trial Monitoring:
- Conduct site qualification, initiation, monitoring, and close-out visits in accordance with Good Clinical Practice (GCP) and applicable regulatory guidelines.
- Ensure trial sites adhere to the approved protocol, ethical guidelines, and regulatory requirements.
- Monitor patient recruitment, data collection, and protocol compliance at assigned sites.
Site and Investigator Support:
- Build and maintain strong relationships with investigators and site staff to ensure smooth trial operations.
- Provide training to site personnel on protocol requirements, study procedures, and regulatory obligations.
- Serve as the primary point of contact for assigned clinical sites.
Documentation and Reporting:
- Verify the accuracy and completeness of case report forms (CRFs) and source data.
- Maintain and ensure timely submission of essential documents to the Trial Master File (TMF).
- Prepare detailed monitoring visit reports and escalate issues as needed.
Compliance and Quality Assurance:
- Identify and resolve site-level issues, including deviations, protocol violations, and adverse events, ensuring proper documentation and corrective actions.
- Support audit and inspection readiness by maintaining high-quality site files and documentation.
Collaboration:
- Work closely with the Clinical Project Manager and cross-functional teams to meet project timelines and objectives.
- Contribute to the review and development of study protocols, informed consent forms, and other trial-related documents.
Qualifications and Experience
Education:
- A degree in Life Sciences, Pharmacy, Nursing, or a related field (Master’s or advanced degree is a plus).
Experience:
- At least 1–3 years’ experience as a CRA in the pharmaceutical, biotech, or CRO industry.
- Hands-on experience with respiratory therapeutic areas or related indications is highly desirable.
- Comprehensive understanding of clinical trial processes, ICH-GCP guidelines, and UK/EU regulatory requirements.
Skills:
- Strong organizational and time-management skills with exceptional attention to detail.
- Excellent written and verbal communication skills for site interactions and reporting.
- Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Ability to travel within the UK and potentially internationally as required (up to 50%).
What We Offer
- Competitive salary and benefits package.
- Opportunities for career growth within a dynamic and innovative biotech company.
- Flexible working arrangements, including hybrid working options.
- The chance to contribute to the development of life-changing therapies for respiratory patients.
Clinical Research Associate employer: Albion Rye Associates
Contact Detail:
Albion Rye Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Research Associate
✨Tip Number 1
Familiarize yourself with the latest developments in respiratory therapies. This knowledge will not only help you during interviews but also demonstrate your genuine interest in the field and the company's mission.
✨Tip Number 2
Network with professionals in the clinical research and biotech industry. Attend relevant conferences or webinars to connect with potential colleagues and learn more about the role of a Clinical Research Associate.
✨Tip Number 3
Prepare for behavioral interview questions by reflecting on your past experiences as a CRA. Think of specific examples that showcase your problem-solving skills, attention to detail, and ability to work under pressure.
✨Tip Number 4
Stay updated on UK and EU regulatory requirements related to clinical trials. Being knowledgeable about these regulations will set you apart as a candidate who is ready to ensure compliance from day one.
We think you need these skills to ace Clinical Research Associate
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Clinical Research Associate position. Understand the key responsibilities and qualifications required, so you can tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in clinical trials, particularly any work related to respiratory therapeutic areas. Be specific about your roles and achievements in previous positions.
Showcase Your Skills: Make sure to highlight your organizational skills, attention to detail, and communication abilities. Provide examples of how you've successfully managed clinical trial processes or collaborated with site staff in the past.
Customize Your Application: Tailor your cover letter to reflect your enthusiasm for the role and the company. Mention why you are interested in working with this particular biotech firm and how your values align with their mission to improve patient outcomes.
How to prepare for a job interview at Albion Rye Associates
✨Know Your Clinical Trial Basics
Make sure you have a solid understanding of clinical trial processes, especially Good Clinical Practice (GCP) guidelines. Be prepared to discuss your previous experiences and how they relate to the responsibilities of a Clinical Research Associate.
✨Showcase Your Communication Skills
As a CRA, you'll need to build strong relationships with investigators and site staff. Practice articulating your thoughts clearly and confidently, and be ready to provide examples of how you've effectively communicated in past roles.
✨Demonstrate Attention to Detail
Attention to detail is crucial in this role. Prepare to discuss specific instances where your attention to detail made a difference in your work, such as identifying protocol deviations or ensuring accurate data collection.
✨Be Ready to Discuss Compliance and Quality Assurance
Familiarize yourself with compliance issues and quality assurance practices. Be prepared to talk about how you've handled site-level issues in the past and your approach to maintaining high-quality documentation.
