Senior Pharmacy Technician Clinical Trials

The pharmacy department at Lewisham & Greenwich NHS Trust (Queen Elizabeth Hospital/ University Hospital Lewisham) have a vacancy for a permanent, senior Pharmacy Clinical Trials Technician to join our friendly pharmacy clinical trials and research-based team. What an exciting time to be a part of research! The post holder will work closely with the Lead Pharmacist for Clinical Trials in the delivery of all pharmaceutical aspects of clinical trials, including co-ordinating and managing the service at a senior level.

We are looking for a forward-thinking, hardworking and dedicated individual to work closely in the multidisciplinary team, including Research and Development, Lead Investigators, Pharmacists, Pharmacy Technicians and assistants. You will help deliver and manage a high-quality clinical trials service across the Trust with the opportunity to gain in-depth knowledge of study protocols and their application in clinical practice.

Interview date: 13th November 2024

In addition to excellent communication and organisation skills, you should be registered with the General Pharmaceutical Council and preferably hold an ACPT qualification and Medicines Management qualification or be willing to undertake this. You must hold a Level 3 NVQ Diploma in Pharmacy Service Skills (or equivalent) and up to date GCP training is essential. Applicants are required to have a minimum of 1-year hospital experience as a qualified Pharmacy Technician in hospital pharmacy or similar.

Main duties of the job

Writing clinical trial working procedures, temperature monitoring, dispensing, communicating with research teams, organising and facilitating sponsor monitored visits, training and line management duties will be part of your daily duties.

For your commitment to us, we will ensure you receive personal development in management skills in an environment that is both supportive and challenging in equal measure. The post holder will also be required to offer 1 day of clinical commitments at ward level each week. Flexible working arrangements will be considered. Please complete your application in line with the Person Specification and Job Description as failure to do so may lead to non-progression to the short-listing stage of the process.

1. To be the Lead Pharmacy Technician for clinical trials, across both sites, supporting the Lead Clinical Trials Pharmacist in the delivery of an efficient Pharmacy Clinical Trials Service across Lewisham and Greenwich NHS Trust.
2. To co-ordinate all clinical trials involving investigational medicinal product (IMP) in the Trust and manage the day-to-day pharmacy operational activities associated with them.
3. Implementing developments to meet the needs of the Clinical Trials service.
4. To undertake line management duties as necessary.

About us

This is an excellent opportunity to be part of our progressive pharmacy team and contribute to our Clinical Trials Service that broadly involves a variety of specialities. We strive to be 'Exceptional' and aim to provide the highest standard of care to our service users. You will be supporting a highly motivated and innovative Pharmacy Clinical Trials team.

Our people are our greatest asset. When we feel supported and happy at work, this positivity reaches those very people we are here for, the patients. Engaged employees perform at their best and our Equality, Diversity & Inclusion (EDI) initiatives contribute to cultivate a culture of engagement.

Job description

Job responsibilities

Key Result Areas & Performance:

Clinical Trials

1. To co-ordinate and maintain the Lewisham and Greenwich Trust Clinical Trials service in accordance with Good Clinical Practice (GCP) and departmental procedures, and ensure a high quality service is provided to patients and staff.
2. To support the Lead Clinical Trials Pharmacist in streamlining Pharmacy Clinical Trial Service across both sites at the Trust and ensure compliance to The Medicines for Human Use (Clinical Trials) Regulations/ EU Clinical Trials Directive and subsequent amendments.
3. To communicate regularly with the Research and Development (R&D) team when organising trials in set-up and delivery and ensuring compliance to local research governance.
4. To facilitate the delivery of an efficient and effective Pharmacy service for Clinical Trial patients and ensure pharmacy staff are trained specifically for each trial in accordance to GCP.
5. To dispense (or check where appropriate) clinical trials involving an IMP following procedures and recording accountability for these as necessary.
6. To manage the temperature monitoring of all IMPs in Pharmacy or other areas as appropriate by recording daily fridge and ambient temperatures.
7. To collate data for workload figures and income generation for hosting of commercial and non-commercial trials to support the Trust R&D activity.
8. To deputise for the Lead Clinical Trials Pharmacist as necessary.
9. To manage queries which arise with clinical trials in the Trust involving an IMP.
10. To facilitate the setup of all clinical trials and those in operation, working closely with the Lead Clinical Trials Pharmacist, Research Teams (Principal Investigators, Research Nurses and Sponsors), R&D and Pharmacy staff.
11. To prepare, maintain and update Standard Operating Procedures for Clinical Trials and provide comprehensive training to ensure a co-ordinated approach for the smooth running of clinical trials from a pharmacy perspective.
12. To ensure that all essential pharmacy trial documentation is maintained in accordance with the protocol and local guidelines.
13. To ensure effective stock control and maintain accurate and up to date storage and expiry records for clinical trial products and archive for future reference.
14. To facilitate stock rotation to prevent wastage.
15. To be responsible for the closing of clinical trials and maintaining trial folders for archive records.
16. To provide GCP training, attend Site Initiation Visits, facilitate Monitoring Visits and be a Pharmacy representative as a point of contact for all clinical trials enquiries.
17. To report suspected or confirmed Investigational Medicinal Products (IMPs) related adverse incidents appropriately and amend local protocol if necessary.
18. To safeguard subjects, healthcare professionals and the Trust by ensuring that IMPs are appropriate for use and are procured, handled, and stored correctly.
19. To ensure that all clinical trials activities are accurately documented, and invoices for Pharmacy are processed according to local procedure.
20. To identify areas of potential cost savings relating to clinical trials service provision and work with the Lead Clinical Trials Pharmacist to action suitably.
21. To undertake audits as necessary to improve and develop the clinical trial services.
22. To liaise with external trial monitors and coordinators to ensure the smooth running of trials locally, to organise and facilitate set up meetings and monitoring visits in Pharmacy.
23. To support and address the clinical trials information and training needs of dispensary staff or other relevant individuals when planning a new clinical trial.
24. To liaise with pharmacy staff responsible for the operational aspects of clinical trials to ensure that all clinical trials activities are carried out to the highest practicable standards of GCP and Good Manufacturing Practice (GMP).

Staff Management & Training

1. To line manage staff, including:
   
   • Providing detailed induction to new staff members in compliance with local and Trust requirements
   • Regular appraisal of performance and objective setting
   • To arrange and document regular 1-2-1 meetings with staff
   • To undertake return to work meetings with staff after periods of absence
   • To performance manage staff where appropriate including managing sickness absence, capability issues, conduct and resolving grievance issues in line with Trust policies
   • Ensuring that all human resource policies, procedures and standards are understood and maintained
   • Ensure all relevant paperwork regarding the above is up to date
2. To participate in recruitment and selection of staff.
3. To undertake health and safety risk assessments for the member of staff they manage.
4. To undertake training of pharmacy, medical and nursing staff and other members of the healthcare team as appropriate for clinical trials and to specifically ensure that all Pharmacy staff receives GCP training commensurate with their roles and responsibilities in relation to trials.
5. To identify own training needs, and actively seek opportunities to meet these, internal and external. To supervise and train Foundation Pharmacy Technicians, Pharmacy Technician and Assistants by being a Practice Supervisor or working towards this accreditation.

Person Specification

Qualifications and Training

Essential

• Level 3 NVQ Diploma in Pharmacy Service Skills (pre 2022) or equivalent Or BTEC Level 3 Diploma in the Principles and Practice for Pharmacy Technicians (post 2022)
• Professional registration with the General Pharmaceutical Council (GPhC)
• Mandatory CPD to maintain fitness to practice
• GCP training

Desirable

• Accredited Checking Pharmacy Technician (ACPT) qualification (Or willing to undertake)
• Practice Supervisor Accreditation (Or willing to undertake)

Experience & Skills

Essential

• Post registration experience in hospital pharmacy for at least 1 year
• Working within a busy dispensary
• Demonstrable experience of training others
• Demonstrable good understanding of clinical trials from a pharmacy perspective
• To competently use MS Office for management and documentation of Clinical Trials
• Display good communication skills as the role liaises with a wide variety of people within the Trust and externally to Sponsors

Desirable

• Previous experience of working in Clinical Trials setting
• Supervision of staff

Knowledge & Skills

Essential

• Good communication skills, both written and oral, of specialist clinical information
• Able to make interventions assertively and appropriately
• Ability to work on own initiative and effectively as part of a team both within pharmacy and a multidisciplinary environment
• Ability to prioritise and plan work effectively alone and for a team including the ability to delegate appropriately
• A good understanding of Good Clinical Practice
• Proficient in all Microsoft Office software with proven computer literacy and IT skills including: o Email o Word processing o Excel

Desirable

• Ability to manage difficult and complex issues or refer appropriately

Personal Qualities

Essential

• Be flexible in responding to demands of the service
• Reliable, polite and approachable
• Knows own professional and personal limitations and seeks advice where necessary.
• Enthusiastic for service development

Other

Essential

• Willingness to contribute to the general life and work of the Pharmacy and Trust
• Willingness to participate in weekend, evening and Bank Holiday rotas as required
• Able to work agreed hours
• Accountability - Takes responsibility for own actions and promotes good team working
• Openness - Shares information and good practice appropriately
• Mutual respect - Treats others with courtesy and respect at all times

Employer details

Employer name

Lewisham and Greenwich NHS Trust

Address

University Hospital Lewisham

Lewisham High Street

London

SE13 6LH

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