Clinical Trials Coordinator - Cambridge Site Lead
Functional Gut ·
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 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 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: sam.treadway@thefunctionalgutgroup.com tharani.chessell@thefunctionalgutgroup.com