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 and experienced Clinical Trials Specialist Technician to join our Pharmacy Department. As a key member of our Clinical Trials team, you will play a vital role in ensuring the smooth conduct of clinical trials and ensuring 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).

Main Duties
  • Provide effective communication within the pharmacy department and with the R&D department, research team, multidisciplinary team and various UK organisations and pharmaceutical companies.
  • Assist the Pharmacy Clinical Trials Manager in the management of the pharmacy aspects of clinical trials of Investigational Medicinal Products (CTIMPs) at University Hospitals Plymouth NHS Trust, including initial trial set-up.
  • Support the pharmacy clinical trial team by contributing to monitoring visits, record keeping, archiving, study set-up and maintenance of study-specific documentation.
  • 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 as set out in study-specific documents, standard operating procedures and appropriate guidelines.
  • 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.
  • Assist with stock control, including the production and checking of routine stock checks and ensuring stock rotation and expiry date checks.
  • Supervise the study trial monitoring and study close-out visits, ensuring that both the pharmacy site files and drug returns are prepared in advance.
  • Respond quickly and appropriately to all enquiries and queries, directing to the most appropriate team member.
  • Carry out archiving of clinical trial documentation and the retrieval of archived documents, if required, ensuring all patient-identifiable data generated as a result of trials are archived in accordance with clinical trials guidance and legislation.
  • Assist in investigating, reporting and recording of errors and near-misses where appropriate and to prioritise effectively.
  • Assist in the supervision, training and appraisals of the trial STO, ATOs and SATOs.
  • Ensure all staff use pharmacy computer systems correctly in relation to Clinical Trials, that data is entered accurately from prescription forms or any other documentation used in the supply of Clinical Trial IMP and that data is stored and archived appropriately in accordance with local and regionally agreed guidelines.
  • Ensure that all trials are run in accordance with GCP, Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) guidelines/department procedures, reporting any deviations to the Pharmacy Clinical Trials Manager.
  • Ensure that pharmacy equipment is kept in a clean and usable condition.
  • Attend GCP training/sessions as appropriate and to work to GCP at all times.
  • Participate in the appraisal process and to undertake appropriate mandatory training.
  • Support and participate in the Sponsor-led audits and undertaking of internal audits, and assist in the implementation of any necessary action following the audit recommendations.
  • Assist with preparation for inspection by the MHRA, FDA, CQC and other regulatory bodies as required.
  • Attend the clinical trials team meeting and other meetings as required.
  • Contribute and assist with advice to pharmacy staff about clinical trials.
  • Be able to adhere to Standard Operational Procedures and policies without supervision.
  • Participate and maintain a record of continuing personal and professional development.
Person Specification

Qualifications

Essential

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

Desirable

  • Computer literate (ECDL)
  • A1 NVQ Assessor Award (or equivalent)

Knowledge

Essential

  • Proven understanding of COSHH
  • Current proven evidence of CPD

Desirable

  • 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

Essential

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

Desirable

  • Ability to motivate others

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