Clinical Trials Coordinator Lead

Job Title:
Clinical Trials Coordinator - Site Lead

Responsible To: Clinical Trials Director

Contract Type: Permanent

Hours: 40 hours per week, Monday to Friday fully site-based

Location: Cambridge

We are looking for an experienced Clinical Trials Coordinator to take ownership of day-to-day clinical operations at our Cambridge clinical site. As the site lead, you will co-ordinate a portfolio of clinical trials, including an ongoing Phase 2b study in irritable bowel syndrome with a novel microbiome therapeutic. You will work closely with our Research and Development team, clinical staff, sponsors and CRAs to deliver high-quality research to Good Clinical Practice (GCP) and regulatory standards.

• Site lead for the FGC Cambridge clinical site, with clinical operations ownership for a portfolio of clinical trials
• Co-ordinate multiple clinical trials and research studies
• Oversee conduct of regulatory-standard clinical trials in line with study protocols, GCP and regulatory requirements
• Manage scheduling of study visits and protocol assessments
• Complete accurate data entry and input of electronic results
• Co-ordinate an ongoing Phase 2b study in irritable bowel syndrome, including recruitment, study visit scheduling and management and sample preparation, when required
• Oversee FGC Cambridge clinical trial staff to ensure trials run efficiently and exceed recruitment targets
• Work closely with sponsors and CRAs to provide documentation and resolve queries raised during monitoring
• Liaise with marketing and digital health teams to promote research and support recruitment
• Support other ongoing research projects, as needed

• Minimum 2:1 BSc in a life science
• At least 1 years' experience as a Clinical Trials Coordinator, or in an aligned role such as Research Assistant or CRA

• Day-to-day management of clinical trial operations
• Familiarity with trial systems and electronic tools (e.g. CTMS, EDC, ePRO)
• Management of study documentation, including TMFs and ISFs, to regulatory standards
• Gastroenterology experience is desirable, but not essential

• Strong organisational skills, with the ability to manage multiple priorities in a fast-paced environment
• Confident working independently and as part of a team, with proven ability to lead
• Solid scientific, statistical and research knowledge
• Excellent verbal and written communication
• Proficient with Microsoft Office and standard clinical trial systems
• Self-motivated, deadline-driven, and comfortable prioritising conflicting workloads
• Professional and considerate in all dealings with participants, site staff, CROs and sponsors
• Proactive about resolving issues and accountable for own workload

• Right to work in the UK
• Willingness to undergo an enhanced DBS check
• Occupational health clearance
• Willingness to complete mandatory training and follow all current policies and procedures
• Flexibility to work outside standard hours, when required
• Willingness to travel within and outside of the UK on occasion (all expenses will be covered)
• Open to undertake ad-hoc duties in support of business needs

• 40 hours per week, Monday to Friday, Cambridge fully site-based
• Paid overtime and TOIL available
• 25 days annual leave (leave year starting 1 March) plus Bank Holidays
• Private Health Cover (following satisfactory completion of 6-month probationary period)
• Access to Employee Assistance Programme
• Birthday day off