Lead Pharmacy Technician - Clinical Trials

Job responsibilities

Job Summary:

1. To be the Lead Pharmacy Technician for Clinical Trials, across both sites, supporting and deputising with the Lead Clinical Trials Pharmacist for the delivery of an efficient Pharmacy Clinical Trials Service across Lewisham and Greenwich NHS Trust.
2. To support and manage the pharmacy team in the delivery of clinical trials involving investigational medicinal products (IMP) and operational services across the Trust. This will include the promotion of safe and cost-effective drug use, appropriate medicines storage and security, and providing a high-quality service.

3. To support the development and implementation of policies, procedures and guidance relating to Clinical Trials as appropriate. This includes undertaking audits, producing reports and implementing any changes that are necessary.

4. To provide technical operational support to the pharmacy department as required by the needs of pharmacy service. This includes line management, supervision, training and support to junior pharmacy technicians, pre-registration trainee pharmacy technicians and other pharmacy staff as necessary.

5. To support your section lead with the delivery of any service developments associated with pharmacy services required to meet local and national requirements.

6. To support the Trusts Clinical Trials team in the co-ordination, implementation, development and delivery of training programmes for pre-registration pharmacy technicians, pharmacy assistants and trainee pharmacists.

7. To deputise for the Lead Clinical Trials Pharmacist for the section of department responsibility as needed.

Key Result Areas & Performance:

Service Development & Delivery1. To support the development of Pharmacy clinical trial services and ensure compliance to the Medicines for Human Use (Clinical Trials) Regulations and subsequent amendments.2. To be registered with the General Pharmaceutical Council as a Pharmacy Technician.3. To co-ordinate and maintain the Lewisham and Greenwich Clinical Trials service in accordance with Good Clinical Practice (GCP) and departmental procedures, by further ensuring a high-quality service is provided to patients and staff.4. To actively support and facilitate the provision of clinical trial pharmacy services within the department or at ward level as necessary to agree performance targets with guidance and support from the section lead.5. To dispense (or check where appropriate) clinical trials involving 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 cold-store and ambient temperatures.7. To investigate any temperature excursions within designated areas and provide timely reports. 8. 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.9. To report suspected or confirmed IMP related adverse incidents appropriately and review local protocol if necessary.10. To support the development and implementation of policies, procedures and guidance for pharmacy department to support best practice of clinical trial pharmacy services.11. To support the development, review and maintenance of pharmacy accreditation programmes for technical staff working within pharmacy clinical trial services.12. To provide GCP training, attend Site Initiation Visits, facilitate Monitoring Visits and be a Pharmacy representative as a point of contact for all clinical trial enquiries.13. To provide supervision for pharmacy technical staff working within the pharmacy department.14. To monitor and evaluate the practice and competency of pharmacy technical staff working in the pharmacy department.15. To identify and highlight areas where interventions concerning safe and secure handling of medicines / IMPs are required, make relevant recommendations, manage queries and support actions by relevant staff members.16. To liaise with external trial monitors and coordinators to ensure the smooth running of clinical trials locally, to organise and facilitate set up meetings and monitoring visits in Pharmacy.17. To organise projects and training in relation to clinical trial pharmacy and as required.18. To perform audits of workload as necessary to streamline quality of service on a regular basis.19. To provide the details of output, performance, and activity at specified time intervals in a format agreed with the Pharmacy Performance Quality Review meeting.20. To collate data for workload figures and income generation for hosting of commercial and non-commercial clinical trials to support the Trusts Research & Development activity.21. To attend and contribute to relevant departmental and Trust meetings as required.22. To contribute to the determination of the future direction of clinical trial pharmacy services through identification of participants / service users and their needs.23. To deputise for the Lead Clinical Trials Pharmacist in their absence as appropriate.

24. To liaise and work closely with other Lead / Senior Pharmacy Technicians, specific areas and across the trust.25. To answer queries, both on the telephone and in person, with medical, nursing staff and patients and seek help from a pharmacist when necessary.26. To investigate / supervise clinical trial incidents occurring within the pharmacy department.27. Results of the investigation may be entered onto the Ulysses risk management system if appropriate.28. To be responsible for the closing of clinical trials and maintaining Pharmacy Site Folders with essential documentation for archive purposes in accordance with protocol and local guidelines.29. To write and maintain standard operating procedures for areas of work within the section assigned to and to participate in the production of clinical policies and procedures.30. To ensure daily workload for the designated area is completed and junior staff handover any relevant information to the appropriate person in the department.31. To act as an Educational Supervisor, Practice Supervisor and / or expert Witness as required.

Leadership and Service Development

1. To participate in the front-line provision of clinical trial pharmacy services as appropriate and when required.2. To safeguard clinical trial participants, healthcare professionals and the Trust by checking IMPs are appropriate for use and are procured, handled, and stored correctly.3. To lead and develop the clinical trial pharmacy service as required. This includes setting and monitoring quality standards for clinical trial pharmacy services and the provision of feedback to the Principal / Chief pharmacy technician.4. To liaise with other senior pharmacy staff to ensure the effective provision of pharmacy clinical trial services.5. To collaborate in the development of Standard Operating Procedures, Patient Group Directions if necessary and any other related policies within the department.6. To identify resources required to improve pharmacy services within the department.7. To support the development, implementation and adherence to local and national guidelines/policies to ensure cost-effective and safe delivery of clinical trial services within the department.8. To identify areas of potential cost savings relating to clinical trials service provision and work with the Lead Clinical Trials Pharmacist to action suitably.9. To liaise with Pharmacy staff responsible for the operational aspects of clinical trials to ensure that all clinical trial activities are carried out to the highest practicable standards of GCP and Good Manufacturing Practice (GMP).

Staff Management & Training

1. To support and address the clinical trials information and training needs of dispensary staff and other relevant individuals when planning a new clinical trial.2. To manage the induction and development of pharmacy staff, according to their identified needs and development and funding framework of the department through liaison with the Principal Pharmacy Technician for Education and Training.3. To participate in recruitment and selection of pharmacy staff.

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 all Pharmacy staff receive GCP training commensurate with their roles and responsibilities in relation to clinical trials.5. To enable the setup of all clinical trials and those in operation, working closely with the Lead Clinical Trials Pharmacist, research teams (Principal Investigators, research nurses, & co-ordinators), and pharmacy staff. 6. To be the direct line manager for senior Pharmacy staff, and delegate to senior staff more junior staff members for all the following, according to Trust procedures

7. To identify the training and development needs of all pharmacy staff involved in delivering clinical trials.8. To facilitate the training and development of pharmacy technicians, pre-registration trainee pharmacy technicians and trainee pharmacy assistants, working in line with service needs and personal development plans.9. To support the Lead Clinical Trials Pharmacist in co-ordinating and delivering education and training to other healthcare staff as required, ranging from one-to one communications to more formal presentations in order to promote medicines pharmacy services and good practice in relation to clinical trials.10. To co-ordinate and advise on Continuing Professional Development (CPD) for all technical staff within Pharmacy.

Qualifications & Training

Essential

• NVQ Level 3 in Pharmacy Services or BTEC in Pharmaceutical Science or equivalent
• Accredited Checking Pharmacy Technician
• Professional registration with the General Pharmaceutical Council (GPhC)
• Specialist knowledge of pharmacy procedures/processes

Desirable

• Other postgraduate qualifications relevant to pharmacy practice, such education & training qualifications

Experience

Essential

• Substantial post registration experience working in hospital pharmacy
• Demonstrable experience and involvement with BTEC training of pre-registration pharmacy technicians.
• Demonstrate experience of training and mentoring others
• Demonstrate experience of line Management
• Educational supervisor qualification

Desirable

• Demonstrable experience of co-ordinating and leading on clinical audit.
• Demonstrable experience of protocol/ guideline development.
• Practice Supervisor qualification
• Assessor qualification

Knowledge & Skills

Essential

• Practical knowledge of role of ward-based pharmacy technicians in provision of medicines management services on wards
• Good understanding of law and good practice related to prescribing, storage and handling of pharmaceuticals
• Demonstrate clinical knowledge of medicines use
• Ability to prioritise and plan work effectively alone and for a team
• Demonstrated ability to communicate complex information effectively using clear written and spoken English and overcome barriers to understanding.
• Ability to work positively and calmly under pressure.
• Proficient in all Microsoft Office software with proven computer literacy and IT skills including: o Email o Word processing o Spreadsheets o Use of search engines/medical databases to retrieve information
• Demonstrated accurate numeric skills

Desirable

• Ability to contribute to the planning of service developments within a department or service
• Evidence of audit and/or project work

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.

Other

Essential

• Willingness to contribute to the general life and work of the Pharmacy and Trust.
• Willingness to participate in weekend, evening, Bank Holiday and late shifts as required.
• Able to work agreed hours

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).