Job summary
We are looking to recruit a rearch and innovation pharmacist to lead management of clinical trials acrross the trust. We are currently both hosting trials but also will be commencing sponsoring of a multi-site national study in 2025/26. This new role has been funded as part of taking on this additional responsibility. You will report to the Chief Pharmacist and be part of the senior pharmacy team/
Main duties of the job
To be the pharmacy lead for R&I based within the pharmacy department for the management of all clinical trials activities in relation to medicines for PCFT. This will include ensuring safe and effective use of trial medication, management of research governance processes, knowledge and skills in relation to clinical trials and close working with all the research networks, Universities, Pharmacy Departments and partner Trusts
About us
We are proud to provide high quality mental health and learning disability services, both inpatient and in the community across five boroughs of Greater Manchester - Bury, Oldham, Rochdale, Stockport and Tameside and Glossop.
Our vision is for a happier and more hopeful life for everyone in our communities and our staff work hard to deliver the very best care for the people who use our services. We're really proud of our#PennineCarePeopleand do everything we can to make sure we're a great place to work.
All individuals regardless of race, age, disability, ethnicity, nationality, gender, gender reassignment, sexual orientation, religion or belief, marriage and civil partnership are encouraged to apply for this post. We would also encourage applications from individuals with a lived experience of mental illness, either individually or as a carer.
If you come and work for us we will offer a range of benefits and opportunities, including:
- Generous annual leave entitlement for Agenda for Change and Medical and Dental staff.
- Flexible working opportunities to support your work/life balance
- Access to Continued Professional Development
- Involvement in improvement and research activities
- Health and Wellbeing activities and access to an excellent staff wellbeing service
- Access to staff discounts across retail, leisure and travel
Job description
Job responsibilities
Develop, review and disseminate guidelines and SOPs for management of Clinical Trials of Investigational Medicinal Products (CTIMPS)
Advise Principal Investigators (PIs) on the legislation and procedures for carrying out clinical trials within PCFT
Support PIs with recruitment to studies involving the wider pharmacy team as appropriate
Advise PIs and other researchers of the current regulations relating to clinical trials applications (Medicines for Human Use (Clinical Trial) Regulations 2004 and subsequent amendments) and provide detailed support with clinical trials applications as required.
Assess the future implications for the Trust of trial outcomes and advise R&I and pharmacy staff of these implications as required.
Be responsible for the review of clinical trial protocols and advise on the pharmaceutical aspects of trial conduct, in line with the European Directive.
Ensure that all clinical trial medicine supplies comply with the National Standards of Good Manufacturing Practice (annex 13).
Source clinical trial supplies according to National Standards as required for investigator-led trials.
Provide a randomisation and blinding service where necessary.
Assess the pharmaceutical service implications of all new clinical trials on the Trust, including wider supply and administration issues using the trust risk assessment tool.
Be responsible for the management of all clinical trial dispensing within the Trust and in conjunction with acute Trust pharmacies via SLAs.
Ensure the management of clinical trial documentation and storage in accordance with National Guidelines at local acute trust sites.
Ensure the security of trial medication, randomisation codes and PIN numbers at all times in line with Good Clinical Practice and company SOPs.
Develop a reputation as a source of specialist advice on clinical trials for healthcare professionals within the Trust and primary care.
Be a lead in the PCFT OptiMed research unit further expanding the unit
Job description
Job responsibilities
Develop, review and disseminate guidelines and SOPs for management of Clinical Trials of Investigational Medicinal Products (CTIMPS)
Advise Principal Investigators (PIs) on the legislation and procedures for carrying out clinical trials within PCFT
Support PIs with recruitment to studies involving the wider pharmacy team as appropriate
Advise PIs and other researchers of the current regulations relating to clinical trials applications (Medicines for Human Use (Clinical Trial) Regulations 2004 and subsequent amendments) and provide detailed support with clinical trials applications as required.
Assess the future implications for the Trust of trial outcomes and advise R&I and pharmacy staff of these implications as required.
Be responsible for the review of clinical trial protocols and advise on the pharmaceutical aspects of trial conduct, in line with the European Directive.
Ensure that all clinical trial medicine supplies comply with the National Standards of Good Manufacturing Practice (annex 13).
Source clinical trial supplies according to National Standards as required for investigator-led trials.
Provide a randomisation and blinding service where necessary.
Assess the pharmaceutical service implications of all new clinical trials on the Trust, including wider supply and administration issues using the trust risk assessment tool.
Be responsible for the management of all clinical trial dispensing within the Trust and in conjunction with acute Trust pharmacies via SLAs.
Ensure the management of clinical trial documentation and storage in accordance with National Guidelines at local acute trust sites.
Ensure the security of trial medication, randomisation codes and PIN numbers at all times in line with Good Clinical Practice and company SOPs.
Develop a reputation as a source of specialist advice on clinical trials for healthcare professionals within the Trust and primary care.
Be a lead in the PCFT OptiMed research unit further expanding the unit
Person Specification
Education / Qualifications
Essential
- Current member of the General Pharmaceutical Council
- Masters degree in Pharmacy (or pre-2000 equivalent)
- Evidence of CPD and commitment to life-long learning
- GCP trained
- Experience in taking part in clinical trials or research
- Substantial post Masters experience
Desirable
- Relevant management qualification or equivalent experience
- Relevant post graduate qualification, i.e. Diploma/MSc in Clinical Pharmacy/ Pharmacy Practice, or Prescribing Sciences (or equivalent experience)
Experience
Essential
- Experience of working in secondary (acute) care
- Variety of clinical pharmacy experience including mental health
- Previous experience of providing R&I services or advice
- Experience in initiating, leading and implementing change and new developments
- Experience of developing guidelines / protocols
- Experience of influencing and negotiating with internal and external stakeholders
- Experience of training healthcare professionals both individually and in groups
Desirable
- Participation in practice based Research
- Knowledge of methods of analysis
- Experience of management
Knowledge
Essential
- Excellent interpersonal skills and the ability to inspire and motivate others, and problem solvw
- Good analytical and presentation skills (verbal and written)
- Good clinical knowledge
- Basic IT literacy (use of e-mail, the internet and word-processing)
- Knowledge of CTIMP processes
- Knowledge of prescribing analysis tools and terminology
- In depth understanding of risk, governance frameworks and standards in relation to research
- Knowledge and experience of clinical audit
- Familiar with health service reforms and the NHS in relation to research
- Knowledge of legislation and regulations relating to pharmacy and use of medicines in research
Desirable
- Enhanced IT skills (including word processing and spreadsheets)
- Knowledge of project management, in particular managing discrete projects from concept to completion
Skills and Abilities
Essential
- Critical appraisal skills
- Data analysis skills
- Excellent written and verbal communication skills
- Ability to work both as a team member and independently
- Ability to work with multi disciplinary, multi-agency groups
- Ability to plan own workload with priorities and objectives and work against tight deadlines
- Presentation and teaching skills
Person Specification
Education / Qualifications
Essential
- Current member of the General Pharmaceutical Council
- Masters degree in Pharmacy (or pre-2000 equivalent)
- Evidence of CPD and commitment to life-long learning
- GCP trained
- Experience in taking part in clinical trials or research
- Substantial post Masters experience
Desirable
- Relevant management qualification or equivalent experience
- Relevant post graduate qualification, i.e. Diploma/MSc in Clinical Pharmacy/ Pharmacy Practice, or Prescribing Sciences (or equivalent experience)
Experience
Essential
- Experience of working in secondary (acute) care
- Variety of clinical pharmacy experience including mental health
- Previous experience of providing R&I services or advice
- Experience in initiating, leading and implementing change and new developments
- Experience of developing guidelines / protocols
- Experience of influencing and negotiating with internal and external stakeholders
- Experience of training healthcare professionals both individually and in groups
Desirable
- Participation in practice based Research
- Knowledge of methods of analysis
- Experience of management
Knowledge
Essential
- Excellent interpersonal skills and the ability to inspire and motivate others, and problem solvw
- Good analytical and presentation skills (verbal and written)
- Good clinical knowledge
- Basic IT literacy (use of e-mail, the internet and word-processing)
- Knowledge of CTIMP processes
- Knowledge of prescribing analysis tools and terminology
- In depth understanding of risk, governance frameworks and standards in relation to research
- Knowledge and experience of clinical audit
- Familiar with health service reforms and the NHS in relation to research
- Knowledge of legislation and regulations relating to pharmacy and use of medicines in research
Desirable
- Enhanced IT skills (including word processing and spreadsheets)
- Knowledge of project management, in particular managing discrete projects from concept to completion
Skills and Abilities
Essential
- Critical appraisal skills
- Data analysis skills
- Excellent written and verbal communication skills
- Ability to work both as a team member and independently
- Ability to work with multi disciplinary, multi-agency groups
- Ability to plan own workload with priorities and objectives and work against tight deadlines
- Presentation and teaching skills
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).
