Job responsibilities
Research
1. Provide operational clinical input into the design and delivery of clinical trial opportunities previously approved by the organisational Research Committee
2. Deliver research clinics including patient facing functions as determined by agreed specifications
3. Assist assurance of compliance with regulatory or commercial third parties criteria by having clear systems to ensure data integrity, quality control and evidence of protocol compliance
4. Ensure all documentation is completed and records are retained for the correct duration
5. Ensure medicines are stored, supplied and disposed of in line with legislative and best practice guidance and recommendations
6. Work with HCL Clinical Pharmacy Technicians in the oversight of any stored medicines
7. Work with HCL Clinical Pharmacy team to raise profile of research within the organisation
8. Liaise proactively with practice teams where appropriate to engage broader clinical research participation
9. Report any adverse events via national (e.g. MHRA Yellow Card), regional and local systems in a timely fashion
10. Produce reports in line with the requirements of the various clinical trials
11. Remain up to date on best practice with regards to delivering Clinical Trials including completing necessary training as recommended by the Head of Pharmacy or Head of Business Intelligence
12. Assist in the development of Pharmacy policies and procedures to support the delivery of clinical trials involving medication and related substances. Oversee the production, implementation and review of detailed written pharmacy guidance and SOPs and liaise with pharmacy teams across the HCL/CLH to ensure effective implementation of these SOPs and initiate change if necessary
13. Train medical, nursing and pharmacy staff in all aspects of handling drugs in clinical trials
14. Report any incidents via HCL Incident Reporting systems to ensure organisational oversight. Incidents should also be reported to external agencies as per the Clinical Trial Protocol and other relevant best practice
15. Work with the Head of Business Intelligence to generate data to evidence impact of trials and role. This may include data gathering and analysis, report writing and presentations.
Support to individual Clinical Trials
a) Set up the trial specific study file with all necessary essential documentation, in preparation for pharmacy sign off by the Trial Chief Investigator
b) Arrange for, and receive investigational medicinal product (IMP) in line with Clinical Trial SOPs and ensure compliance with GMP legislation
c) Maintain the professional expertise to be able to prescribe and to employ this during as part of a clinical trial if required and within own scope of competence
d) Support the multidisciplinary team meetings with investigators to initiate, manage and close down trials hence ensuring pharmacy participation
e) Adhere to the appropriate disposal procedure of unwanted trial materials
f) Liaise with the Head of Pharmacy and HCL Research Lead when assessing, approving or initiating new projects, and update all necessary stakeholders
g) Act as a source of Research expertise to advise on complex issues such as trial design, procurement, randomisation, blinding, and documentation for in-house clinical trials and to defend/justify the opinions or decisions if the advice is challenged
Primary Care Clinical Pharmacy service
- Undertake clinical medication reviews with patients with multi-morbidity and polypharmacy and implement prescribing changes (as an independent prescriber) and order relevant monitoring tests
- Manage own case load and run longer term conditions where responsible for prescribing as an independent prescriber for conditions where medicines have a large component whilst remaining within scope of practice and limits of competence
- Work in partnership with healthcare colleagues and implement improvements to patients medications including de-prescribing
- Support practice staff and patients to manage medicines queries
- Identify national and local policy and guidance that affects patient safety through the use of medicines and devices including MHRA alerts, product withdrawals, medicines shortages etc.
- Ensure medication safety processes are implemented for patients in the practice this could include routine high risk drug monitoring, clinical audits etc.
Professional Role
a) To ensure confidentiality is maintained at all times
b) To be professionally accountable for actions and advice.
c) To be aware of training and competency assessment of pharmacist trainees, diploma pharmacists and student pharmacy technicians and to participate in their training and competency assessment as required
d) Participate in Continuous Professional Development
e) Conduct Clinical Trial medication screening and dispensing checks
f) To attend Clinical Trial specific training course(s) to maintain and update knowledge including web based learning
g) Any other reasonable duties as requested by the Head of Pharmacy
Other services
1. Support the establishment of additional clinical services that may need to be mobilised e.g. Travel clinics
2. Ensure active engagement with Head of Pharmacy and Head of Business Intelligence to ensure joined up working across the services
3. From time to time, it may be necessary to support the HCL Pharmacy team with delivery of clinical tasks as relevant to training, experience and competence
4. Provide clinical and medicines optimisation advice to staff and patients for the service as relevant to role
5. Signpost any queries to the appropriate teams to support patient care
6. Support the site preparedness for CQC inspections and attend inspections to provide clinical and pharmaceutical assurance to the inspecting team
7. Recognise personal limitations and refer to more appropriate colleagues where necessary
8. Work collaboratively with multi-disciplinary team on site, HCL colleagues as well as other health and social care professionals across the system
