Description

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.
ResponsibilitiesTechnical Skills

• Proficient in Microsoft Office (Word, Excel, Outlook)
• Experience with electronic document management systems (e.g., eTMF)
• 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

RequirementsStudy 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., ClinicalTrials.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

BenefitsAs 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