At a Glance
- Tasks: Support clinical trials and ensure compliance with regulations while collaborating with diverse teams.
- Company: Join a rapidly growing UK pharmaceutical company dedicated to improving patient lives globally.
- Benefits: Enjoy competitive salary, flexible working hours, and a comprehensive benefits package.
- Other info: Be part of a vibrant culture with excellent growth opportunities and exciting company events.
- Why this job: Make a real impact in healthcare while developing your career in a supportive environment.
- Qualifications: Degree in Life Sciences and experience in clinical operations required.
The predicted salary is between 40000 - 50000 £ per year.
Competitive Salary & Company Benefits| Remote or Hybrid Working
Monday to Friday, 9.00am - 5.00pm (potential for flexibility on start/end times based on 7.5hrs/day).
Are you looking to work for a rapidly growing UK Pharmaceutical company, who are passionate about improving patients’ lives across the world?
Aspire Pharma is an asset-light pharmaceutical manufacturer.
It licenses and develops niche pharmaceutical products that offer innovative formulations, value for money for payors, and reliable supply arrangements in markets which are often underserved.
The business has a highly diversified portfolio of more than 250 products across a number of categories, including branded specialty products and unbranded niche generics in therapeutic areas such as urology, ophthalmology, CNS and dermatology.
Do you want to be part of the journey? If so, here is your chance!
The Role
We are currently looking to recruit a Clinical Research Associate (CRA).
The CRA provides essential operational and administrative support to the delivery of clinical trials and bioequivalence studies.
This role plays a key part in ensuring studies are conducted efficiently, on time, and in compliance with ICH GCP, Aspire SOPs, and applicable regulatory requirements.
The CRA is responsible for maintaining high-quality, inspection-ready documentation, supporting study coordination activities, and enabling effective collaboration across cross-functional teams, vendors, and external partners.
This is a hands‑on role suited to a detail-oriented professional who thrives in a fast-paced, regulated environment.
- Job requirements
- Technical Skills
- Proficient in Microsoft Office (Word, Excel, Outlook)
- Experience with electronic document management systems (e. g., e TMF)
- Familiarity with clinical trial management systems (CTMS) is desirable
- Experience with Adobe Acrobat and electronic signature tools
- Professional Qualification & Experience
- Degree in Life Sciences subject or a related field
- Typically, 5-10 years’ experience in clinical operations within the pharmaceutical or CRO industry
- Experience supporting clinical trials and/or bioequivalence studies
- Experience working in a GCP-regulated environment
- Experience working with a sponsor organisation is desirable
- Experience in a virtual or outsourced operating model is advantageous
- Knowledge, Skills, & Competencies
- Strong understanding of ICH GCP and applicable regulatory requirements (EMA/FDA desirable)
- High attention to detail with a strong focus on quality and compliance
- Excellent organisational and time management skills
- Strong written and verbal communication skills
- Ability to work collaboratively in cross-functional and global teams
- Proactive approach to problem-solving and risk identification
- Ability to manage multiple priorities in a fast-paced environment
- Job Responsibilities
- Study Coordination & Support
- Support the day-to-day running of clinical trials and bioequivalence studies
- Oversee all aspects of trial management, be the main point of contact for internal and external stakeholders, and actively support audits/inspections
- Assist project teams in planning, tracking, and delivering study milestones
- Assist in the preparation and review of study protocols, informed consent forms and study reports
- Identify and escalate risks or issues that may impact study delivery
- Documentation & Compliance
- Set up, maintain, and ensure completeness of Trial Master Files (TMF) and sponsor oversight files (electronic and/or paper) in accordance with clinical trial requirements
- Ensure all study documentation is accurate, up-to-date, and inspection-ready
- Perform quality control checks on clinical trial documentation
- Track key document milestones to ensure ongoing regulatory compliance
- Support audit and inspection readiness activities, including resolution of findings
- Systems & Tracking
- Maintain and update clinical trial tracking systems (e. g., CTMS, trackers)
- Ensure accurate recording of study progress, documentation status, and key metrics
- Support data integrity and consistency across systems
- Meeting & Vendor Coordination
- Coordinate clinical trial meetings, including scheduling, logistics, and preparation of materials
- Prepare and distribute meeting agendas and minutes
- Support communication and coordination with CROs, vendors, and study sites
- Regulatory & External Activities
- Support posting and maintenance of study information on external platforms (e. g., Clinical Trials. gov)
- Assist with preparation and distribution of study documentation to sites
- Collaborate with Regulatory, Quality, and Pharmacovigilance teams to ensure compliance
- Cross-functional Collaboration
- Work closely with R&D, Regulatory Affairs, Quality, Pharmacovigilance, and other stakeholders
- Support internal and external project managers in study-related activities
- Contribute to process improvements and operational efficiency initiatives
- General Support
- Provide broader administrative support to the R&D function as required
- Support additional clinical operations activities in line with business needs
Why Join Us?
As well as a fantastic, inclusive company culture, where employees are truly valued, and a competitive salary, we also offer an ever-improving benefits scheme to support your physical and mental well‑being which include:
- Company pension scheme.
- Life Assurance cover and Employee Assistance Program.
- 25 days’ holiday plus bank holidays.
- Learning and development opportunities.
- Excellent opportunities for progression.
- Fantastic company events and celebrations throughout the year.
- Cycle to Work Scheme
- Private healthcare schemes
- #J-18808-Ljbffr
Clinical Research Associate (CRA) employer: Aspire Pharma Ltd
Aspire Pharma is an exceptional employer, offering a dynamic and inclusive work culture that prioritises employee well-being and professional growth. With flexible working arrangements, competitive salaries, and a comprehensive benefits package, including private healthcare and generous holiday allowances, employees are empowered to thrive both personally and professionally. Join a rapidly growing pharmaceutical company dedicated to making a meaningful impact on patients' lives while enjoying ample opportunities for career advancement in a supportive environment.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Research Associate (CRA)
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Aspire Pharma Ltd. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Aspire Pharma Ltd.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Aspire Pharma Ltd. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Aspire Pharma Ltd is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Clinical Research Associate (CRA)
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Aspire Pharma Ltd!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Aspire Pharma Ltd that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Aspire Pharma Ltd!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Aspire Pharma Ltd, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Aspire Pharma Ltd
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Aspire Pharma Ltd that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Aspire Pharma Ltd’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
