Job summary
To organise and maintain all Pharmacy Clinical Trials in conjunction with the Clinical Trials Pharmacist and the Clinical Trials Pharmacy Technician team. To work closely with the local R&D office and the Clinical Trials Office ensuring compliance with ICH GCP guidelines, The Research Governance Framework, the E.U Clinical Trials Directive and other relevant guidelines, regulations and policies.
To write precise and concise standard operating procedures (SOPs) for each new clinical trial with respect to dispensing, final checking and procurement of Investigational Medicinal Products (IMPs) which are checked and approved by the Clinical Trials Pharmacist.
To be responsible for stock control and for the return and subsequent storage and reconciliation of clinical trial medications according to relevant SOPs.
Partake in Dispensary activities as an ACT as directed by Deputy Director of Pharmacy and Pathology.
Main duties of the job
Knowledge
Pharmaceutical knowledge in mental health
Have an up to date working knowledge of ICHGCP guidelines and the EU Clinical Trials Directive
Skills
Good written and oral skills needed for communicating with pharmacy team members, other healthcare professionals, clinical trials organisations and members of the public
Good negotiation skills
Patient counselling skills
Demonstrates initiative and problem solving skills
Prioritisation skills and excellent organisation skills and be capable of managing own workload
Demonstrates the ability to work unsupervised and to work to deadlines/targets
Ability to exercise own initiative when dealing with clinical trials issues with own area of competence
Ability to recognise limitations of own remit and know when to refer problems outside of this
Competent computer skills, able to use Excel, Word etc to set up documents and spreadsheets and extract information
Use of Hospital pharmacy computer system
Personality/Disposition:
Ability to work under pressure whilst maintaining attention to detail and accuracy
Prepared to take responsibility
Flexible in accepting new procedures and policies and manage change
Proactive and self- motivated
Positive and optimistic
Well organised
About us
South London and Maudsley NHS Trust (SLaM) provides a full range of mental health services to the people of Croydon, Lambeth, Southwark and Lewisham as well as national specialist services. The Trust has a major role in postgraduate training of doctors, pharmacists, psychologists, nurses and therapists. It has a leading role in devising and evaluating new treatments. In addition it has a broad research agenda in mental health, which informs new NHS mental health policies. South London and Maudsley NHS Foundation Trust are part of Kings Health Partners Academic Health Sciences Centre.
Job description
Job responsibilities
1. Assist in the day to day management of Clinical Trials (CT) at SLaM in conjunction with the CT Pharmacist and Technician team. Ensure that all CT files contain all the necessary documentation, are kept up to date and contain all relevant regulatory approvals.
2. Review prospective clinical trial prescription forms supplied by research organisations and assess suitability for use or required amendments before the trial commences and make recommendations for amendments. Review clinical trial protocols prior to approval, at SLaM assessing the suitability and safety relating to packaging, labelling, shipment, storage and dispensing of study medication and make recommendations for changes when appropriate. Ensure that processes and SOPs are in place for the accurate dispensing of CTs in relation to the above activities ensuring that they meet the required standard.
3. Write a clear synopsis for each clinical trial protocol for the Pharmacy Trial file. Prepare (and update as required) clear and accurate written dispensing procedures for dispensing staff for each clinical trial in accordance with the International Conference for Harmonisation for Good Clinical Practice (ICHGCP) and each study's protocol.
4. In conjunction with the CT Pharmacist review KHP overarching SOPs as requested.
5. Create drug accountability records, patient ID logs and other documents where the study sponsor has not provided them. Audit files regularly to ensure accurate completion of records and that files contain all required material and comply with current guidelines and legislation across SLaM pharmacies. Ensure there are 'codebreaking' procedures in place for drug treatments in case of emergency. Perform 'close down' for CTs and ensure that trial documents are archived as per SOPs.
6. Dispense and check CT medications ensuring each item is accurately dispensed and in the correct packaging, according to SOPs. Complete dispensing records, accurately recording batch numbers, expiry date and provide patient information according to each clinical trial. Perform the final accuracy check on dispensed IMPs, as an Accredited Checking Technician (ACT), according to SOPs. Organise the timely supply of medications to patients on wards and at home. Prioritise and delegate to other pharmacy team members as necessary and communicate any delays in supply to the appropriate person/team.
7. Manage the security and maintenance of all CT drugs from receipt, storage and return or destruction and ensure that the necessary documentation audit trail is present in accordance with all legal requirements and each study's protocol. Responsible for ensuring that storage conditions for IMPs are temperature monitored. Responsible for the maintenance of electronic and/or manual temperature records. Responsible for routine monitoring visits. To act as a pharmacy representative during trial audits and inspections. To act as a role model for pharmacy staff providing a clinical trials service, participate in departmental meetings to keep staff up to date with trial specific issues. Supervise dispensary staff to ensure that work is conducted to a high standard and in accordance with SOPs and ICH GCP.
8. To assist in the training of SLaM staff in relation to clinical trials.
9. To communicate regularly and arrange and participate in meetings with internal Investigators (senior physicians), research nurses and with trial organisers (monitors etc) in sponsoring organisations to establish and maintain a good working relationship and to provide a prompt and effective pharmacy clinical trials service. To ensure effective communication throughout the pharmacy service of any Clinical Trials developments and across the Trust as necessary. Counsel and provide information to patients, or their chosen representative on the use of their medications, offering advice, and answering queries within own remit and referring to the appropriate healthcare professional where appropriate. Act as a pharmacy contact at SLaM for CTs.
10. Responsible for monitoring the clinical trial income. Assist with providing pharmacy cost information to Investigators for grant applications for new studies and non-commercial trials. To assist in ensuring that commercial trials are charged for appropriate activity at the agreed NCVR rates. To ensure final pharmacy fees are submitted for commercial trials following close out.
11. Compile monthly dispensing figures to send to SLaM finance. Liaise with research teams and SLaM finance to invoice non-commercial trial pharmacy charges.
12. Assist with refurbishment planning for the CT Pharmacy and to take part/lead in other service improvement projects.
Job description
Job responsibilities
1. Assist in the day to day management of Clinical Trials (CT) at SLaM in conjunction with the CT Pharmacist and Technician team. Ensure that all CT files contain all the necessary documentation, are kept up to date and contain all relevant regulatory approvals.
2. Review prospective clinical trial prescription forms supplied by research organisations and assess suitability for use or required amendments before the trial commences and make recommendations for amendments. Review clinical trial protocols prior to approval, at SLaM assessing the suitability and safety relating to packaging, labelling, shipment, storage and dispensing of study medication and make recommendations for changes when appropriate. Ensure that processes and SOPs are in place for the accurate dispensing of CTs in relation to the above activities ensuring that they meet the required standard.
3. Write a clear synopsis for each clinical trial protocol for the Pharmacy Trial file. Prepare (and update as required) clear and accurate written dispensing procedures for dispensing staff for each clinical trial in accordance with the International Conference for Harmonisation for Good Clinical Practice (ICHGCP) and each study's protocol.
4. In conjunction with the CT Pharmacist review KHP overarching SOPs as requested.
5. Create drug accountability records, patient ID logs and other documents where the study sponsor has not provided them. Audit files regularly to ensure accurate completion of records and that files contain all required material and comply with current guidelines and legislation across SLaM pharmacies. Ensure there are 'codebreaking' procedures in place for drug treatments in case of emergency. Perform 'close down' for CTs and ensure that trial documents are archived as per SOPs.
6. Dispense and check CT medications ensuring each item is accurately dispensed and in the correct packaging, according to SOPs. Complete dispensing records, accurately recording batch numbers, expiry date and provide patient information according to each clinical trial. Perform the final accuracy check on dispensed IMPs, as an Accredited Checking Technician (ACT), according to SOPs. Organise the timely supply of medications to patients on wards and at home. Prioritise and delegate to other pharmacy team members as necessary and communicate any delays in supply to the appropriate person/team.
7. Manage the security and maintenance of all CT drugs from receipt, storage and return or destruction and ensure that the necessary documentation audit trail is present in accordance with all legal requirements and each study's protocol. Responsible for ensuring that storage conditions for IMPs are temperature monitored. Responsible for the maintenance of electronic and/or manual temperature records. Responsible for routine monitoring visits. To act as a pharmacy representative during trial audits and inspections. To act as a role model for pharmacy staff providing a clinical trials service, participate in departmental meetings to keep staff up to date with trial specific issues. Supervise dispensary staff to ensure that work is conducted to a high standard and in accordance with SOPs and ICH GCP.
8. To assist in the training of SLaM staff in relation to clinical trials.
9. To communicate regularly and arrange and participate in meetings with internal Investigators (senior physicians), research nurses and with trial organisers (monitors etc) in sponsoring organisations to establish and maintain a good working relationship and to provide a prompt and effective pharmacy clinical trials service. To ensure effective communication throughout the pharmacy service of any Clinical Trials developments and across the Trust as necessary. Counsel and provide information to patients, or their chosen representative on the use of their medications, offering advice, and answering queries within own remit and referring to the appropriate healthcare professional where appropriate. Act as a pharmacy contact at SLaM for CTs.
10. Responsible for monitoring the clinical trial income. Assist with providing pharmacy cost information to Investigators for grant applications for new studies and non-commercial trials. To assist in ensuring that commercial trials are charged for appropriate activity at the agreed NCVR rates. To ensure final pharmacy fees are submitted for commercial trials following close out.
11. Compile monthly dispensing figures to send to SLaM finance. Liaise with research teams and SLaM finance to invoice non-commercial trial pharmacy charges.
12. Assist with refurbishment planning for the CT Pharmacy and to take part/lead in other service improvement projects.
Person Specification
Education and Training
Essential
- NVQ Level 3 Pharmaceutical Sciences or a recognised equivalent
- Registration with the General Pharmaceutical Council (GPhC), with mandatory CPD
- Accredited checking technician course successfully completed
- Current GCP certificate
Experience
Essential
- Experience working in a hospital pharmacy clinical trials service
- Demonstrate experience of writing SOPs and research documents
- Experience of dispensing and organising clinical trials
- Experience of working with ICHGCP guidelines and the EU Clinical Trials Directive
- Demonstrated ability to work with other healthcare professionals
Desirable
- Experience in training of other staff
- Familiar with WellSky (JAC) computer system
Knowledge
Essential
- Have an up to date working knowledge of ICHGCP guidelines and the EU Clinical Trials Directive
Desirable
- Pharmaceutical knowledge in mental health
Skills
Essential
- Good written and oral skills needed for communicating with pharmacy team members, other healthcare professionals, clinical trials organisations and members of the public
- Good negotiation skills
- Demonstrates initiative and problem solving skills
- Prioritisation skills and excellent organisation skills and be capable of managing own workload
- Demonstrates the ability to work unsupervised and to work to deadlines/targets
- Ability to exercise own initiative when dealing with clinical trials issues with own area of competence
- Ability to recognise limitations of own remit and know when to refer problems outside of this
- Competent computer skills, able to use Excel, Word etc to set up documents and spreadsheets and extract information
Desirable
- Patient counselling skills
- Use of Hospital pharmacy computer system
Personality / Disposition
Essential
- Ability to work under pressure whilst maintaining attention to detail and accuracy
- Prepared to take responsibility
- Flexible in accepting new procedures and policies and manage change
- Proactive and self- motivated
- Positive and optimistic
- Ability to achieve demanding tasks and objectives against deadlines
Physical
Essential
- Must be able to travel across SL&M sites as required
- Manipulation eg: use of syringes
- Dispensing of medication, including assembly of blister packs/dosette boxes
Person Specification
Education and Training
Essential
- NVQ Level 3 Pharmaceutical Sciences or a recognised equivalent
- Registration with the General Pharmaceutical Council (GPhC), with mandatory CPD
- Accredited checking technician course successfully completed
- Current GCP certificate
Experience
Essential
- Experience working in a hospital pharmacy clinical trials service
- Demonstrate experience of writing SOPs and research documents
- Experience of dispensing and organising clinical trials
- Experience of working with ICHGCP guidelines and the EU Clinical Trials Directive
- Demonstrated ability to work with other healthcare professionals
Desirable
- Experience in training of other staff
- Familiar with WellSky (JAC) computer system
Knowledge
Essential
- Have an up to date working knowledge of ICHGCP guidelines and the EU Clinical Trials Directive
Desirable
- Pharmaceutical knowledge in mental health
Skills
Essential
- Good written and oral skills needed for communicating with pharmacy team members, other healthcare professionals, clinical trials organisations and members of the public
- Good negotiation skills
- Demonstrates initiative and problem solving skills
- Prioritisation skills and excellent organisation skills and be capable of managing own workload
- Demonstrates the ability to work unsupervised and to work to deadlines/targets
- Ability to exercise own initiative when dealing with clinical trials issues with own area of competence
- Ability to recognise limitations of own remit and know when to refer problems outside of this
- Competent computer skills, able to use Excel, Word etc to set up documents and spreadsheets and extract information
Desirable
- Patient counselling skills
- Use of Hospital pharmacy computer system
Personality / Disposition
Essential
- Ability to work under pressure whilst maintaining attention to detail and accuracy
- Prepared to take responsibility
- Flexible in accepting new procedures and policies and manage change
- Proactive and self- motivated
- Positive and optimistic
- Ability to achieve demanding tasks and objectives against deadlines
Physical
Essential
- Must be able to travel across SL&M sites as required
- Manipulation eg: use of syringes
- Dispensing of medication, including assembly of blister packs/dosette boxes
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.
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).
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.
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).
