Clinical Trials Specialist Technician

4 weeks ago

Plymouth, Plymouth, United Kingdom University Hospitals Plymouth NHS Trust Full time

Job Summary

University Hospitals Plymouth NHS Trust is seeking a highly skilled Clinical Trials Specialist Technician to join our Pharmacy Department. As a key member of our team, you will play a vital role in ensuring the smooth conduct of clinical trials and 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).

This is an exciting opportunity for a motivated and experienced pharmacy technician to develop their skills in all aspects of clinical trials. You 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 our 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, you will have the opportunity to work on a wide range of clinical trials and contribute to the development of our team.

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 coordinate the management of clinical trials prepared in the Pharmacy Production Services to ensure all drug products are prepared to a high standard.
  • To prepare the first draft of master product documentation for new products and the first draft of new standard operating procedures under the direction of the Pharmacy Clinical Trials Manager or Advanced Specialist Pharmacist Clinical Trials.
  • To assist with stock control, including the production and checking of routine stock checks, and ensuring stock rotation and expiry date checks.

Person Specification

Qualifications

  • BTEC/NVQ Level 3 in pharmacy services (or equivalent)
  • Accredited checking technician qualification
  • Registered pharmacy technician (with the GPhC)

Knowledge

  • Proven understanding of COSHH
  • Current proven evidence of CPD
  • Good working proven knowledge of current procedures and working practices
  • Proven knowledge of ordering and receiving medications and goods
  • Proven knowledge of stock control
  • Proven knowledge of distributing medication and goods
  • Good working proven knowledge of current legislation, department of health guidelines, and Medicines and Healthcare Regulatory Agency regulations concerning aseptic preparation and manufacture
  • A proven understanding of the clinical research process, including Good Clinical Practice and research governance
  • Demonstrable experience working as a pharmacy technician in a hospital environment, post-qualification
  • Demonstrable experience of clinical trials pharmacy practice and procedures

Aptitude and Abilities

  • Good written and verbal communication skills with the ability to demonstrate fluency, clarity, and effectiveness
  • Good training skills

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