Specialist Technician Clinical Trials

Plymouth Hospitals do; Plymouth; On-site; GBP 29,000 - 37,000; Full time

Job summary

An established industry player is seeking a dedicated Specialist Technician for Clinical Trials. This role offers a unique opportunity to support a dynamic clinical trials team in a progressive healthcare environment. You will be responsible for ensuring compliance with national legislation and providing essential support in all aspects of clinical trials, particularly in oncology and haematology studies. With comprehensive training and career development opportunities, this position is ideal for those looking to make a significant impact in clinical research. Join a team where your contributions truly matter and be part of a forward-thinking organization committed to excellence in patient care.

Qualifications

• Essential qualifications include BTEC/NVQ Level 3 in pharmacy services.
• Registered pharmacy technician with an accredited checking qualification.

Responsibilities

• Assist in management of pharmacy clinical trials and ensure compliance.
• Coordinate workload for clinical trials and supervise junior staff.
• Maintain accurate records and assist in general dispensing duties.

Skills

Good written and verbal communication skills

Training skills

Understanding of COSHH

Current evidence of CPD

Education

BTEC/NVQ Level 3 in pharmacy services

Accredited checking technician qualification

Registered pharmacy technician

Job description

Join to apply for the Specialist Technician Clinical Trials role at University Hospitals Plymouth NHS Trust.

Job Summary
University Hospitals Plymouth NHS Trust is pleased to offer an exciting opportunity for a Band 5 Specialist Technician Clinical Trials to assist the Pharmacy Clinical Trials Manager and Advanced Specialist Pharmacist Clinical Trials in all aspects of clinical trials and ensure compliance with current national legislation, the International Conference of Harmonisation Good Clinical Practice (ICH GCP) guidance and the UK Policy Framework for Health and Social Care Research (2023) in the conduct of clinical research.

This post provides an opportunity for the post holder to enjoy comprehensive training and to develop their skills in all aspects of clinical trials. They will be responsible for pharmacy clinical trial set-up and maintenance activities as well as dispensing and accuracy checking investigational medicinal products (IMPs).

You will be part of the Pharmacy Department's well-established and dedicated Clinical Trials team supporting the Trust's growing portfolio of clinical research across all clinical specialties, with a particular focus on oncology and haematology studies, from phase 1 to phase 4. The Trust has also been at the forefront for COVID-19 Vaccine studies and is looking to grow its portfolio of Phase 1 studies within our Clinical Research Facility.

For an informal discussion or to arrange a site visit please contact Mike Marner, Pharmacy Clinical Trials Manager at [e-mail].

Main Duties of the Job

• To work with other members of the pharmacy and research team to ensure that the rights, safety and well-being of trial participants are protected.
• To support the pharmacy clinical trial team by contributing to monitoring visits, record keeping, archiving, study set up and maintenance of study specific documentation.
• To oversee, and if needed coordinate the management of workload for clinical trials prepared in the Pharmacy Production Services to ensure all products are prepared in a timely manner.
• To supervise the work and to complete the training and competency assessment of Assistant Technical Officers (ATOs), Senior Assistant Technical Officers (SATOs), Specialist Technical Officer (STO), rotational technicians, and student technicians.

About Us
We are a people business - where every member of staff matters and can make a difference. Patients are at the heart of everything we do. Joining University Hospitals Plymouth NHS Trust means becoming part of a team of dedicated staff, who are committed to leading the way through innovation, clinical excellence and great customer care. The Trust has great opportunities for career development in a highly progressive working environment.

Pay Scheme: Agenda for Change
Band: Band 5
Salary: £29,970 to £36,483 a year
Contract: Permanent
Working Pattern: Full-time
Job Locations: Pharmacy Department, Level 5, Derriford Road, Plymouth, PL6 8DH

Job Responsibilities

• To provide effective communication within pharmacy department and with the R&D department, the research team, multidisciplinary team and various UK organisations and pharmaceutical companies.
• To assist the Pharmacy Clinical Trials Manager in management of the pharmacy aspects of clinical trials of Investigational Medicinal Products (CTIMPs) at University Hospitals Plymouth NHS Trust to include initial trial set up.
• To assist Pharmacy Clinical Trials Manager and liaise with R&D finance team to invoice sponsors appropriately.
• To assist Pharmacy Clinical Trials Manager and to provide costs of medication to R&D finance team for clinical trial agreements and model agreement for non-commercial research.
• To participate in feasibility assessment of potential CTIMPs.
• To undertake general dispensing duties, in accordance with standard operating procedures and the legal framework for the supply of medicines.
• To perform a final accuracy check on items dispensed by other members of the trial team.
• To coordinate and ensure medications are ready according to priorities e.g. clinical urgency and time of appointment.
• In collaboration with the pharmacy clinical trials team and research team to ensure accurate record keeping of drug accountability of all clinical trials (both written and computer records).
• To contribute to the efficient stock control of all clinical trial products by undertaking regular stock checks.
• To monitor appropriate storage of all clinical trial products ensuring storage condition records and accurate expiry records for all clinical trial products are kept up to date.
• To be responsible for the return and subsequent storage and reconciliation of Clinical trials IMP in line with the relevant pharmacy clinical trial SOPs.
• To supervise the study trial monitoring and study close out visits ensuring that both the pharmacy site files and drug returns are prepared in advance.
• To respond quickly and appropriately to all enquiries and queries.
• To carry out archiving of clinical trial documentation and the retrieval of archived documents, if required.
• To assist in investigating, reporting and recording of errors and near-misses.
• To assist in the supervision, training and appraisals of the trial STO, ATOs and SATOs.

Person Specification

• Qualifications Essential
  • BTEC/NVQ Level 3 in pharmacy services (or equivalent)
  • Accredited checking technician qualification
  • Registered pharmacy technician (with the GPhC)
• Knowledge Essential
  • Proven understanding of COSHH
  • Current proven evidence of CPD
• Aptitude and Abilities Essential
  • Good written and verbal communication skills
  • Good training skills

Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and will require a submission for Disclosure to the Disclosure and Barring Service.