Swydd-ddisgrifiad a phrif gyfrifoldebau manwl

Clinical Trials

1.    Act as nominated pharmacy lead to a defined group of research teams. Provide pharmaceutical advice on the conduct of CTIMP trials and assess study requirements and resolve pharmaceutical issues with the research teams.

2.    Lead on the evaluation of study protocols for designated disease groups and consider implications within pharmacy (capacity, safety and resources). Provide timely feedback to stakeholders.

3.    To monitor, document and advise on the financial implications of designated studies to the Senior Pharmacists for Clinical Trials, R&I, finance and the Director of Pharmacy.

4.    Maintain systems and processes to ensure that all trial related activity is conducted in accordance with the Research Governance Framework for Health & Community Care, ICH GCP guidelines, GMP principles, current Medicines for Human Use (Clinical Trials) Regulations and along with any other local legal/regulatory requirements.

5.    Promote regulatory compliance across all clinical research services within pharmacy.

6.    Prepare comprehensive risk assessments related to the Control of Substances Hazardous to Health and advise key staff accordingly in relation to handling, labelling and product evaluation for all new products used in clinical trials.

7.    To assist the clinical trials pharmacist team, with prescription proforma development for any new clinical trial regimens being set-up and checking any pharmacy specific relevant paperwork before a trial opens for recruitment.

8.    To support the pharmacy department through any internal or external audits.

9.    To participate in departmental, Trust and national risk management schemes such as error reporting systems and intervention monitoring.

10.    Report to the senior pharmacist for clinical trials on all issues related to clinical trial activity within department.

11.    Provide written reports on activity, regulatory compliance and financial positions to pharmacy and R&I staff as required.

12.    Act as a resource for staff within R&I division. To be responsible for providing formal advice and specialist training sessions for Christie staff on all pharmaceutical aspects of new and existing trials.

13.    Facilitate the updating of all pharmacy staff on issues related to clinical trials.

General Responsibilities 

1.    To manage and resolve any clinical or dispensing queries with regards to patients’ trial prescriptions to maintain high standard of patient care, assisting technical staff with day-to-day queries where appropriate.

2.    To support the provision of clinical pharmacy services within the dispensaries and the aseptic services unit. Responsible for the clinical screening/review of prescriptions, both in-patients and outpatients, and to accurately check and supply medicines to patients, including clinical trials in accordance with all departmental, Trust and national standards, procedures and policies.

3.    To participate in the pharmacist rota for the clinical screening of prescriptions, including clinical trial prescriptions within the dispensary and facilitate safe and effective screening /review of prescriptions for chemotherapy regimens, clinical trials and treatment strategies in use at The Christie, including full awareness of the intrathecal chemotherapy policy. Following local, Trust and National guidelines for safe medicines practice.

4.    To attend meetings relevant to role where required.

5.    To participate in Continuing Professional Development ensuring relevant knowledge and skills are up to date, meeting the professional requirement of the General Pharmaceutical Council. 

6.    To participate in mandatory training in line with the trust and departmental requirements.  To participate in all departmental rotas, extended hours weekend service and bank holiday working and the emergency on-call pharmacy service, as required.

7.    To behave in a manner at all times that is in accordance with the professional standards set by the General Pharmaceutical Council

8.    Undertake all other related duties which may be required in accordance with the changing needs and practices of the department and organization.

Aseptic Services

1.    To assist and advise with the review, preparation and development of aseptic/clinical trial standard operating procedures, worksheets, labels, guidelines and master documents as appropriate. To validate these documents by signature where required.

2.    To be responsible with other pharmacists for the provision of professional input to the clinical review of prescriptions for aseptic/clinical trial dispensing and the resolution of any clinical issues, liaising with medical or nursing staff as necessary.

3.    To be responsible with other pharmacists working within Aseptic services for the clinical screening, final check, release and issue for administration of items prepared within the service area, ensuring that all paperwork is complete and retained for future requirements relating to drug recalls.

4.    To provide evidence-based medicines advice to ensure safe, effective, economical and timely use of medicines, in particular IV therapy.

5.    To have an understanding and awareness of all clinical trial protocols requiring aseptic manipulation, in particular pharmaceutical and clinical aspects, and safety and handling issues.

The duties of the post may be varied with the agreement of the post holder in accordance with the changing needs and practices of the department and organization.