Specialist Technician Clinical Trials

Job overview

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)

The Trust has also been in the forefront for COVID 19 Vaccine studies and in the future 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 [email protected]

• 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 contribution to monitoring visit, record keeping, archiving, study set up and maintenance of study specific documentation.
• To oversee, and if needed to 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.

***Preference will be given to internal Trust staff, as well as ‘Priority’ and 'At Risk' status including NHS At Risk staff throughout Devon who are able to display recent relevant experience as dictated by the Person Specification.***

Working for our organisation

It is sometimes necessary to close vacancies before the closing date. If you have not heard from us within 4 weeks of the closing date, please assume that you have not been shortlisted.

Detailed job description and main responsibilities

1. 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.
2. 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.
3. To assist Pharmacy Clinical Trials Manager and liaise with R&D finance team to invoice sponsors appropriately
4. 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
5. To participate in feasibility assessment of potential CTIMPs
6. To undertake general dispensing duties, in accordance with standard operating procedures and the legal framework for the supply of medicines:

Labelling - generate accurate medication labels

Dispensing - accurately dispense inpatient, outpatient and discharge prescriptions, including clinical trials, cytotoxic drugs and controlled drugs.

1. To perform a final accuracy check on items dispensed by other members of the trial team.
2. To coordinate and ensure medications are ready according to priorities e.g. clinical urgency and time of appointment
3. 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 investigate and document any discrepancies, and report to the appropriate sponsor’s representative.
4. To contribute to the efficient stock control of all clinical trial products by undertaking regular stock checks to ensure sufficient (IMP/trial-specific) “in date” stock for current and new patients.
5. To participate in the ordering and receipt of clinical trials products following trial protocols, study specific instructions and the departmental SOPs.
6. To monitor appropriate storage of all clinical trial products (including clinical trial products stored outside of pharmacy) ensuring storage condition records and accurate expiry records for all clinical trial products are kept up to date and archived for future reference according to GCP and GMP Guidelines.
7. To process amendments to clinical trials e.g. updated pharmacy manuals, promptly and accurately ensuring that trial specific guides and dose preparation worksheets are updated following review and new procedures put in place if applicable.
8. To be responsible for the return and subsequent storage and reconciliation of Clinical trials IMP in line with the relevant pharmacy clinical trial SOPs relating to efficient stock control, issue and return or safe disposal of drugs relating to clinical trial IMP.
9. 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. Also ensuring the completion of any and all follow up actions.
10. To respond quickly and appropriately to all enquiries and queries, directing to most appropriate team member.
11. To 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.
12. Assist in investigating, reporting and recording of errors and near-misses where appropriate and to prioritise effectively.
13. To assist in the supervision, training and appraisals of the trial STO, ATOs and SATOs.
14. To 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.
15. To 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.
16. To ensure that pharmacy equipment is kept in a clean and usable condition.
17. To attend GCP training/sessions as appropriate and to work to GCP at all times.
18. To participate in the appraisal process and to undertake appropriate mandatory training.
19. 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.
20. Assist with preparation for inspection by the MHRA, FDA, CQC and other regulatory bodies as required
21. To attend the clinical trials team meeting and other meetings as required.
22. To contribute and assist with advice to pharmacy staff about clinical trials.
23. To be able to adhere to Standard Operational Procedures and policies without supervision.
24. To participate and maintain a record of continuing personal and professional development.

1. 1. To oversee, and as required to 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.
2. 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 Trial Manager or Advanced Specialist Pharmacist Clinical Trials.
3. 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)

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

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 provenunderstanding 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 ability to demonstrate fluency, clarity and effectiveness
• Good training skills

• Ability to motivate others

PLEASE NOTE THAT ALL COMMUNICATION WILL BE ELECTRONIC, PLEASE CHECK YOUR EMAIL ACCOUNT REGULARLY INCLUDING YOUR JUNK FOLDER.

If you need support with the online application process or require reasonable adjustments with the application and/or interview process please contact the Recruiting Manager for this post.

We recognise that work life balance is important for our colleagues and so we invite requests from applicants about less than full time/flexible working for our advertised roles. We recommend contacting the manager of the role prior to applying and we commit to giving requests full consideration.

We welcome and encourage applicants who identify with all protected characteristics to apply for our roles. We believe that diversity strengthens our teams and improves our patients' experience. At UHP we aim to create an inclusive workplace and hospital where everyone feels they belong and included.

It is sometimes necessary to close vacancies before the closing date. If you have not heard from us within 4 weeks of the closing date, please assume that you have not been shortlisted.

Providing false information is an offence & could result in the application being rejected or summary dismissal/police action if an applicant is successful.

This is an automated process & the information will only be used for these purposes prior to your taking up the position with us.

For Doctors Roles:

Unsolicited CVs and Candidate Profiles/Details

University Hospitals Plymouth has a commitment to sourcing candidates directly and as such we do not accept speculative CVs from agencies.

We do, however, work with a defined list of preferred HTE Framework suppliers who may be invited to support us in sourcing candidates for particular roles.

In line with our preferred supplier list, we only pay agency fees where we have a signed agreement in place and an agency has been instructed by a member of the Trust’s Medical Workforce team.

We do not pay agency fees where speculative and unsolicited CVs are submitted to the Trust or Trust employees by any other means than the official route above. Where this is not observed the Trust reserves the right to contact these candidates directly and initiate discussions without payment of any agency fee.

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Submission of any unsolicited CVs, candidate’s details and/or proposals to the Trust will not be considered further and will be deemed evidence of full and unlimited acceptance of this Agency Protocol.

In order to establish and maintain good working relationships with the Trust’s agency suppliers, we ask that this Protocol is adhered to and thank you for your co-operation.