Principal Trial Coordinator - Head of Amendments and GCP- QA

Principal Trial Coordinator - Head of Amendments and GCP- QA NHS AfC: Band 6

Main area Pharmacy, Research, Clinical Trials Grade NHS AfC: Band 6 Contract Permanent On-site Work Hours Full time - 37.5 hours per week (On site Only) Job ref 196-LIS9378

Employer Guy's and St Thomas' NHS Foundation Trust Employer type NHS Site Guy's Hospital and St Thomas Hospital Town London Salary £44,806 - £53,134 per annum incl. HCA Salary period Yearly Closing 01/04/:59

Job overview

This is an exciting opportunity to join our Clinical Trials (Adult) Pharmacy Department. The department manages, between two sites (Guy's Hospital and St Thomas' Hospital), a portfolio of over 900 Clinical Trials ranging from early stage Phase I studies to Post license Phase IV studies; handling a multicohort of molecules from Advanced Therapies to traditional investigational medicinal formulations. The successful applicant will be working alongside industry leading clinical researchers within GSTT and from abroad on set up and management of clinical Trials at site level.

Main duties of the job

Study Amendments

1. Act as an Accountable Person on managing Pharmacy Amendments
2. Receive, organise, process and manage a portfolio of Clinical Trials Amendment Notifications in a systematic way using agreed quality systems such as Amendment Tracker incorporated with various data sets
3. Liaise with Amendments Central Coordinating Team based at GSTT R&D and King's Health Partners' Clinical Trials Office (KHP-CTO), and undertake amendment related activities.
4. Escalate and discuss complex Amendment matters that requires expert attention, to Highly Specialist Clinical Trials Pharmacist and / or other delegated CT Pharmacists
5. Periodically review internal Amendment processes and procedures in order to optimise them to achieve performance, regulatory compliance and meet HRA targets
6. Undertake periodical internal Audits of Amendment processes and its GCP compliance within the Pharmacy Clinical Trials Department

GCP: - Operations, Quality and Assurance

Ensure all staff members who works for Pharmacy Clinical Trials (CT) department are up to date with their GCP certification.

Person specification Experience

• Extensive experience in clinical trials project management
• NHS / Academic/Industry Experience in Clinical Trials
• Clinical Trials Data Handling
• GCP Audits certification

Qualifications

• Science Graduate or Graduate in Pharmaceutical Sciences
• QCF Pharmacy services Level 3 (NVQ level 3) plus an accredited underpinning knowledge (BTEC in Pharmaceutical Science or equivalent) or Equivalent Pharmacy Technicians whom are qualified via other GPhC approved routes
• Registered as a Pharmacy Technician with the General Pharmaceutical Council
• Any comparable or superior qualifications to the above three criteria

Skills

• Excellent organisational and interpersonal skills
• Excellent verbal and written advanced communication skills.
• Ability to analyse and rationalise clinical trials information. Ability to make complex decisions
• Experience of creating, managing, and delivering administrative projects
• Knowledge of the UK Policy Framework for Health and Social Care Research and other regulatory issues relating to medical/clinical research