JOB DESCRIPTION
JOB TITLE
:
Chief Technician Clinical Trials
DEPARTMENT
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Pharmacy Department Heartlands, Solihull & Good Hope Hospitals
GRADE
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HOURS OF DUTY
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Band 6
37.5 hours per week. The Trust operates a 7 day working policy. The
hours will include weekend, late night and bank holiday working on a
rotational basis
MANAGES
:
All Technician, ATO and A&C staff in area of responsibility.
ACCOUNTABLE TO
:
Clinical Director of Pharmacy
RESPONSIBLE TO
:
Principal Pharmacist Clinical Trials
JOB SUMMARY
The Chief Technician manages the technical/non technical work and is responsible for the specialist
functions of own pharmacy areas, taking responsibility for solving complex problems and dealing with a
broad range of non-routine issues, which are often unpredictable.
The Chief Technician manages the technical staff and their day to day activities of area of work,
including training, appraisal and performance management of all grades of staff in the specialist area(s)
and planning of workload.
The Chief Technician works with the Deputy Director/Pharmacy Clinical Services and Pharmacy
operational site leads in planning the strategic development of Pharmacy specialist services. In all
sections operational policies incorporating protocols and guidelines apply.
Participates in the strategic development of services in their specialist area(s).
The Chief Technician will ensure quality-monitoring systems are applied and results are to agreeable
standards.
KEY WORKING RELATIONSHIIPS
Clinical Director of Pharmacy
Principal Pharmacist clinical trials
Pharmacists, Pharmacy operational site leads, Computer services manager, other Chief Technicians,
technicians and support staff on all sites.
Nursing, medical and other healthcare staff both Trust and non-trust
Patients and their relatives/carers, including those with language problems or other disabilities.
External bodies in connection with specialist area(s), including Trust and non-trust customers.
Interface Prescribing Manager
KEY RESULT AREAS
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Co-ordinating and planning an accurate and efficient provision of pharmacy clinical trials service for
Heartlands, Good Hope and Solihull Hospitals.
Ensures correct storage and handling of pharmaceuticals in accordance with Controls Assurance
Standard.
Promotes effective communication.
Manages pharmacy technicians, student technicians and other support staff working within
pharmacy specialist area(s).
Assistance in computer development and support related to pharmaceutical services.
Participates in the development and delivery of procedures in own area and contributes to the
policy development for other areas.
Participates in recruitment selection for staff in own area and other areas on request.
Dispensing accuracy and checking technician accreditation.
Responsible for achieving KPI targets within area of work
DUTIES AND RESPONSIBILITES
The postholder: 1. Manages performance and motivates staff in their area.
2. Plans and implements changes in practice in their area including networking with colleagues across
the region to share best practise and innovations
3. Has responsibility for the day-to-day operational management and technical operation of the
specialist area(s) or services.
4. Deputises for other Chief Technicians/Pharmacy operational site lead(s)where appropriate.
5. Ensures clinical efficacy, safety and compliance with Good Manufacturing Practice/Medicines
legislation and any legislation or guidance relating to outsourced medicines or service provision.
6. Ensures that policies and procedures are written and are reviewed regularly and are disseminated
effectively.
7. Ensures that Trust and pharmacy policies and procedures are adhered to.
8. Ensures that policies and procedures comply with Health & Safety and COSHH Regulations
9. Ensures appropriate records are maintained.
10. Monitors performance against standards, auditing appropriately including written reports. Has
involvement with the Pharmacy operational site leads, on recruitment of technicians and assistant
technical officer into their area of responsibility.
11. Is involved in dispensing, provision of advice and counselling of patients, in area of speciality,
according to the need.
12. To be responsible for actioning drug alerts/product recalls within the Trust.
13. Operates and maintains an appraisal system for staff in the team and identifies training needs.
14. Manages performance and sickness absence in accordance with Trust policy
15. Assists tutors in training and development of pre-registration pharmacists/student technicians in the
relevant areas.
16. Work in conjunction with other Chief Technicians to promote good communication to pharmacy
services, both internal and external to the department.
17. Responsible for maintaining correct stock levels in the pharmacy and works closely with other
pharmacy staff to ensure correct stock levels in the relevant area and that quality of the data is of a
high standard.
18. Participating in the development of computerised systems with other Chief Technicians as
appropriate with the needs of the Trust.
19. Take part in projects and audits appropriate to this area of responsibility.
20. Liaises closely with external suppliers to ensure efficient delivery of service to the Trust.
21. Handles complex problems or specific technical issues, which are non-routine.
22. Carries out any other duties as may be required within the nature and grade of pos
CLINICAL TRIALS COMPONENT
Operationally manages clinical trials in pharmacy at base site providing an effective and efficient service
to patients, research nurses, investigators, Research and Development Department and
commercial/non-commercial sponsors.
Works with trials pharmacists to ensure that HOEFT pharmacy trial SOPs comply with current UK
legislation, developing and implementing new SOPs as part of the team. Ensures that individual drug
trials comply with these SOPs.
Writes/creates trial procedures, documentation and labelling for drug trials in the Trust ensuring
accuracy and compliance with the Medicines for Human Use (Clinical Trials) regulations 2004, ICHGCP
and the Pharmaceutical Society Guidelines.
Receive, store, dispense, record, carry out return accountability and removal/destruction of trial drugs
following procedures within the specific Pharmacy study file. Ensure documentation for the trial is
completed correctly, kept up to date and the file well maintained. Responsible for ‘close down’ and
archiving of trials as per trial SOPs.
Responsible for co-ordinating cancer studies run between trials pharmacy, ward 19 pharmacy and ADU
by organising trial files for all areas and meeting regularly with relevant pharmacy staff to discuss
individual trial procedures, addressing any training issues.
Audit trial files regularly for accurate completion of records and required documentation to comply with
current legislation and guidelines, so files are ready for inspection by external auditors.
Meet with Clinical Research Associates/Trial Co-ordinators for monitoring visits/audits.
Liaise with the lead trials technician at all three sites on trial issues and procedures to ensure cross-site
quality standards are met.
Train, advice and support trial staff at all three sites ensuring that study files contain relevant
documentation, accurate dispensing and recording procedures and are compliant with trial SOPs,
current legislation and guidelines.
Ensure accurate temperature monitoring and record keeping for trial drug storage is carried out in
accordance with UK/EU requirements, promptly quarantining stock and reporting temperature
excursions. Maintain records of calibration of equipment.
Attend Pharmacy initiation meetings for new drug trials set up in the Trust.
Advise pharmacy, medical, nursing staff, Department of R and D and sponsors on pharmaceutical issues
of drug trials.
Provide induction training for new pharmacy staff. Provide clinical trial training programme for
pharmacy staff within the Trust, including updating existing staff. Maintain records of training.
Act as lead to trial technicians in training, supervising and advising on the writing of trial procedures,
documentation and labelling for trials within the Trust.
Take part in regular pharmacy trial team meetings, and multi-disciplinary team meetings to maintain a
well co-ordinated Pharmacy clinical trial service to HOEFT
Undertake regular specialised training and development in order to meet the skill needs of the job and
to maintain current awareness.
DISPENSARY COMPONENT
Carries out the final check of the dispensing process as an accredited checking technician
Undertake routine Dispensary work on a rota system as required by technicians working within HEFT
General
Infection control
Staff will work to minimise any risk to clients, the public and other staff from Healthcare Associated
Infection including MRSA and C difficle by ensuring they are compliant with the Health Act 2006 – Code
of Practice For The Prevention and Control of Healthcare Associated Infections (They Hygiene Code); and
by ensuring they are familiar with the Trust’s Infection Control Polices, located on the Intranet.
All employees must comply with the Trust Infection Control Policy. All employees must attend infection
control training as required within their department or as directed by their line manager.
Confidentiality
As an employee you have a responsibility to maintain the confidentiality of any confidential information
which comes into your possession regarding patients, employees or any other business relating to the
Trust
In accordance with the Public Interest Disclosure Act 1998 protected disclosures are exempt from this
express duty of confidentiality.
Health & Safety
As an employee you have a responsibility to abide by all of the safety practices and codes provided by
the Trust and have an equal responsibility with management for maintaining safe working practices for
the health and safety of yourself and others.
All employees must comply with the Trust Infection Control Policy. All employees must attend infection
control training as required within their department or as directed by their line manager
Quality Assurance
As an employee of the Heart of England NHS Foundation Trust you are a member of an organisation that
endeavours to provide the highest quality of service to our patients. You are an ambassador of the
organisation and, as such, are required to ensure that high standards are maintained at all times.
As an employee you have a responsibility for data quality. All employees are accountable for the quality
of data they input into Trust systems and/or document in paper-based records, and must ensure that it
is accurate, complete, valid and timely at all times.
Equal Opportunities
As an employee you have a responsibility to ensure that all people that you have contact with during the
course of your employment, including patients, relatives and staff are treated equally in line with the
Trust’s Equal Opportunities Policy.
Risk Management
You have a responsibility for the identification of all risk which have a potential adverse affect on the
Trust’s ability to maintain quality of care and the safety of patients, staff and visitors, and for the taking
of positive action to eliminate or reduce these.
Safeguarding
Heart of England NHS Foundation Trust has a responsibility to safeguarding and promoting the welfare
of children, young people and vulnerable adults who use our services. The Trust expects all staff and
volunteers to share this responsibility. As part of the selection process for this post you may be required
to undergo a Criminal Records Bureau check and maintain ISA registration. If you are successful
appointed, you will receive confirmation of which checks and/or registration you are required to have.
The Job Description is subject to change and may be reviewed by the manager in conjunction with the
post holder.
The Trust operates a no smoking policy and is working towards a smoke free environment.
Updated:
Jan 2013