Job summary
We are pleased to offer the opportunity for an
enthusiastic and motivated person to join the friendly specialist clinical
trials pharmacy team, as a Lead Technician for Clinical Trials.
There is already a strong clinical trials team in
place, consisting of seven core staff and a further five, who work jointly with
other departments within pharmacy. The
pharmacy clinical trials team are currently working on over 100 trials involving
investigational medicinal products.
Main duties of the job
The successful applicant would join an experienced
team of specialist clinical trial pharmacy staff who provide a comprehensive
service to oncology/ haemato-oncology and other specialities including
diabetes, ophthalmology, hepatology, ENT and intensive care. The pharmacy clinical trial service is
provided from both the main dispensary and the dedicated trial dispensary in
the St Luke;s Cancer centre, along with significant input from the pharmacy aseptic
services department. The base for much
of the work will be the clinical trial office in the main hospital.
We are looking for a technician who shows accurate
attention to detail, has good organisational skills and is able to prioritise
work effectively. The role will require you to communicate and interact with a
wide range of staff within the Trust and representatives of external trial
organisations. GCP experience is desirable but enthusiasm for research and
development of new treatments is essential.
A flexible working option will also be considered.
If you wish
to have an informal chat or arrange a visit to discuss this post further please
contact:
Nadia Hunter,
Chief technician, clinical trials (Mo-We, Fr) 01483 571122 ext 2453 n.hunter@nhs.net
Gaybrielle
Livingstone, lead pharmacist, clinical trials (Tu-Fr) 01483 571122 ext 2453 g.livingstone@nhs.net
Rebecca
Wills, lead pharmacist clinical trials (Mo-Th) 01483 571122 ext 2453 rebecca.wills@nhs.net
About us
Royal Surrey NHS Foundation Trust is a friendly, supportive, busy but welcoming acute and community Trust that is ambitious about developing our services and your career.
Our compassionate, caring and friendly colleagues make up our Royal Surrey family and are at the heart of what we do. We all have a passion for learning, continuous improvement and excelling together through innovation, research and development. There are over 4,500 members of our Royal Surrey family.
We are clinically led and provide joined up care by bridging the gap between hospital and community services alongside regional specialist cancer care. Our main acute hospital site is in Guildford with community hospital sites at Milford, Haslemere and Cranleigh. We provide adult community health services in the community and homes across Guildford and Waverley.
We have received an overall Good rating from the CQC with Medical care (including older peoples care), End of Life Care and Maternity services being deemed Outstanding by the CQC. We are investing in our colleagues through our health and wellbeing programme and a commitment to supporting professional development as well as investing more than £45 million in our physical environment and new equipment in the next few years.
There has never been a better time to join us.
Job description
Job responsibilities
JOB PURPOSE
The
post holder will be responsible for managing their own cohort of clinical
trials including set-up, maintenance and closedown of trials and co-ordinate
the management of the Investigational
Medicinal Products in all pharmacy trials.
They will be responsible for ensuring
compliance with current legislation, the international ethical and scientific
quality standard laid down in The International Conference on Harmonisation
guidelines for Good Clinical Practice relating to trials (ICH GCP) and The EU
Clinical trials directive (2001/20/EC) as transposed into UK law by the
Medicines for Human Use (Clinical Trials ) Regulations 2004 (the legislation),
and any other legislation or standards for the conduct of clinical trials
(including maintaining records, writing and reviewing SOPs and training).
JOB SUMMARY
- To work as part of the
pharmacy clinical trials team in providing a clinical trials service in line
with standard operating procedures, good clinical practice (GCP) and relevant
legislative requirements
- Assist with the day-to-day
management of the clinical trials service including set up, maintenance and
closure.
- To maintain all records
in compliance with ICH-GCP and standard operating procedures relevant to the
trial
- To assist with
developing training packages for pharmacy technicians and pharmacists; and
deliver both scheduled and ad hoc training as necessary, including to nurses or
other research staff where appropriate
- Responsible for
organising and delivering induction training and competency validation
programmes for clinical trials and GCP for all levels of staff within the
pharmacy (dispensing and checking clinical trials)
- Assist with the
development and implementation of standard operating procedures, induction,
training and competency programmes for clinical trials.
- Participate in both
internal and external trial audits ensure compliance with GCP and current
clinical trials legislative requirements
- Liaise with both
hospital staff involved in research and external users to ensure the smooth
running of clinical trials.
- Actively participate in
the development of clinical trials services
- Responsible for writing
and implementing trial specific Standard Operating Procedures in accordance with departmental SOPs
- To deputise for the
Chief Pharmacy Technician in their absence
- Dispense and label
oncology and non-oncology clinical trial prescriptions
- Accuracy check oncology
and non-oncology clinical trial prescriptions.
- Responsible for
recording drug and patient accountability on the relevant paperwork in line
with GCP. Investigating and reconciling stock discrepancies if needed
- Responsible for
temperature monitoring within clinical trials and ensuring appropriate action
is taken to deal with temperature deviations and missing quality assurance
documents
- Responsible for the
ordering, receipt, storage and documentation of clinical trial material, in
partnership with the other lead technicians for clinical trials.
- Responsible for the
line management of pharmacy staff allocated to the post holder including
recruitment and selection, and performance management.
- Responsible for
updating and maintaining records on EDGE, the electronic research data
management system
- Responsible for
ensuring invoice requests are raised and income is logged to ensure pharmacy
fees are received
Job description
Job responsibilities
JOB PURPOSE
The
post holder will be responsible for managing their own cohort of clinical
trials including set-up, maintenance and closedown of trials and co-ordinate
the management of the Investigational
Medicinal Products in all pharmacy trials.
They will be responsible for ensuring
compliance with current legislation, the international ethical and scientific
quality standard laid down in The International Conference on Harmonisation
guidelines for Good Clinical Practice relating to trials (ICH GCP) and The EU
Clinical trials directive (2001/20/EC) as transposed into UK law by the
Medicines for Human Use (Clinical Trials ) Regulations 2004 (the legislation),
and any other legislation or standards for the conduct of clinical trials
(including maintaining records, writing and reviewing SOPs and training).
JOB SUMMARY
- To work as part of the
pharmacy clinical trials team in providing a clinical trials service in line
with standard operating procedures, good clinical practice (GCP) and relevant
legislative requirements
- Assist with the day-to-day
management of the clinical trials service including set up, maintenance and
closure.
- To maintain all records
in compliance with ICH-GCP and standard operating procedures relevant to the
trial
- To assist with
developing training packages for pharmacy technicians and pharmacists; and
deliver both scheduled and ad hoc training as necessary, including to nurses or
other research staff where appropriate
- Responsible for
organising and delivering induction training and competency validation
programmes for clinical trials and GCP for all levels of staff within the
pharmacy (dispensing and checking clinical trials)
- Assist with the
development and implementation of standard operating procedures, induction,
training and competency programmes for clinical trials.
- Participate in both
internal and external trial audits ensure compliance with GCP and current
clinical trials legislative requirements
- Liaise with both
hospital staff involved in research and external users to ensure the smooth
running of clinical trials.
- Actively participate in
the development of clinical trials services
- Responsible for writing
and implementing trial specific Standard Operating Procedures in accordance with departmental SOPs
- To deputise for the
Chief Pharmacy Technician in their absence
- Dispense and label
oncology and non-oncology clinical trial prescriptions
- Accuracy check oncology
and non-oncology clinical trial prescriptions.
- Responsible for
recording drug and patient accountability on the relevant paperwork in line
with GCP. Investigating and reconciling stock discrepancies if needed
- Responsible for
temperature monitoring within clinical trials and ensuring appropriate action
is taken to deal with temperature deviations and missing quality assurance
documents
- Responsible for the
ordering, receipt, storage and documentation of clinical trial material, in
partnership with the other lead technicians for clinical trials.
- Responsible for the
line management of pharmacy staff allocated to the post holder including
recruitment and selection, and performance management.
- Responsible for
updating and maintaining records on EDGE, the electronic research data
management system
- Responsible for
ensuring invoice requests are raised and income is logged to ensure pharmacy
fees are received
Person Specification
Qualifications
Essential
- NVQ Level 3 in Pharmacy Services plus underpinning knowledge from BTEC in Pharmaceutical Science or an equivalent accredited qualification
- Registration with the UK General Pharmaceutical Council (GPhC)
Desirable
- Successful completion of National Accredited Checking Technician Scheme (ACPT) or an equivalent accredited qualification.
- Valid GCP certificate
- Qualified Educational Supervisor
Experience
Essential
- 2 Years Post Qualification as a Pharmacy Technician in a hospital or CT environment)
- Evidence of ongoing training and CPD
Desirable
- Previous experience of clinical trials
- Previous training experience
- Experience dealing with a multidisciplinary team
- Evidence of staff management and supervision including delegation
- Evidence of implementing changes
- Previous recruitment experience
Person Specification
Qualifications
Essential
- NVQ Level 3 in Pharmacy Services plus underpinning knowledge from BTEC in Pharmaceutical Science or an equivalent accredited qualification
- Registration with the UK General Pharmaceutical Council (GPhC)
Desirable
- Successful completion of National Accredited Checking Technician Scheme (ACPT) or an equivalent accredited qualification.
- Valid GCP certificate
- Qualified Educational Supervisor
Experience
Essential
- 2 Years Post Qualification as a Pharmacy Technician in a hospital or CT environment)
- Evidence of ongoing training and CPD
Desirable
- Previous experience of clinical trials
- Previous training experience
- Experience dealing with a multidisciplinary team
- Evidence of staff management and supervision including delegation
- Evidence of implementing changes
- Previous recruitment experience
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.
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
Additional information
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.
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
