Clinical Trials Coordinator - Cambridge Site Lead

Role Overview

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

While professional experience and qualifications are key for this role, make sure to check you have the preferable soft skills before applying if required.

Role Summary:

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.

This is a hands-on, high-visibility role for someone who thrives on organisation and delivery, enjoys leading a team and who would value having ownership of a clinical site. You will report directly to, and work closely with, our Clinical Trials Director giving you direct exposure to operational strategy and study design. You will be central to all aspects of clinical operations from participant recruitment to regulatory submissions, with scope to shape how the site operates and grows, and to build a track record of success across multiple clinical trials.

Key Responsibilities:

• 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

Main duties:

1. Co-ordinate an ongoing Phase 2b study in irritable bowel syndrome, including recruitment, study visit scheduling and management and sample preparation, when required

2. Oversee FGC Cambridge clinical trial staff to ensure trials run efficiently and exceed recruitment targets

3. Work closely with sponsors and CRAs to provide documentation and resolve queries raised during monitoring

4. Liaise with marketing and digital health teams to promote research and support recruitment

5. Support other ongoing research projects, as needed

Person Specification:

Qualifications

• 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

Experience

• 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

Skills & Approach

• 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 xwzovoh staff, CROs and sponsors
• Proactive about resolving issues and accountable for own workload

General Requirements

• 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

Salary and Benefits

• £50,000 - £55,000 per annum; permanent contract
• 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)
• Employee pension scheme
• Access to Employee Assistance Programme
• Bike2work scheme
• Birthday day off

Any questions please contact: