Deputy Lead Pharmacist for Clinical Trials

Job responsibilities

DUTIES AND RESPONSIBILITIES

Duties/Responsibilities:

Clinical trials

1. Act as nominated pharmacy lead to a minimum of one disease. 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).
3. To monitor, document and advice on the financial implications of designated studies to Lead Pharmacists for Clinical Trials, R&D, finance and the Director of Pharmacy.
4. Maintain systems and processes to ensure that all trial related activity is conducted in accordance with the UK Policy Framework for Health and Social Care Research ICH GCP guidelines, GMP principles, Medicines for Human Use (Clinical Trials) Regulations 2004 and the EU directive along with any other local legal/regulatory requirements.
5. Promote regulatory compliance across all of its 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 lead 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&D staff as required.
12. Act as a resource for staff within R&D 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.

Deputy Lead Duties/Responsibilities

1) Work alongside the Lead Pharmacist for Clinical Trials to implement strategy, aims and objectives for the Pharmacy Clinical Trials Service with other members of the team and with the Director of Pharmacy and R+D Operational leads.

2) Work alongside the Lead Pharmacist for Clinical Trials to deliver a strategy for the pharmaceutical management of oncology clinical trials and report this to Director of Pharmacy and the Divisional Board in the absence of the Lead Pharmacist for Clinical Trials.

3) Assist the Lead Pharmacist for Clinical trials for assessing the pharmacy clinical trials services in all relevant areas of the department and reporting these assessments appropriately.

4) Assist the Lead Pharmacist for Clinical Trials to ensure that the pharmacy Clinical Trials team ensures that the needs of the service and its users are met. The Clinical Trials team is responsible for the safe delivery of investigational medicinal products (IMP) as part of a clinical trial service. This would range from dispensing of the IMP to writing policies / protocols for implementation of the IMP.

5) Complete annual appraisals for direct reports where requested and ensure that members of staff in the clinical trials team have an annual appraisal in line with trust guidelines and according to agreed timetable.

6) Be able to deputise under the guidance of the Lead Pharmacist for Clinical Trials where necessary and take leadership in decision making where required.

General Pharmacy Responsibilities/Requirements

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 participate in the pharmacist rota for the clinical screening of clinical trials prescriptions and within the clinical trials 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.
3. To attend meetings relevant to role where required.
4. To participate in Continuing Professional Development ensuring relevant knowledge and skills are up to date, meeting the professional requirement of the General Pharmaceutical Council.
5. To participate in mandatory training in line with the trust and departmental requirements. To participate in all departmental rotas, extended hours Saturday service and Bank Holiday working and the emergency on-call pharmacy service as required.
6. To behave in a manner at all times that is in accordance with the professional standards set by the General Pharmaceutical Council
7. Undertake all other related duties which may be required in accordance with the changing needs and practices of the department and organisation.
8. Demonstrates the agreed set of values and accountable for own attitude and behaviour

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 organisation.

Qualifications

Essential

• Current GPhC Registration.
• Degree in Pharmacy
• Evidence of Continuing Professional Development

Desirable

• Postgraduate diploma in clinical pharmacy or equivalent

Experience

Essential

• Experience of working in clinical trials.
• Experience of working in oncology
• Experience of working within a hospital environment

Desirable

• Experience of Training both Pharmacy and multidisciplinary staff
• Work in multi-disciplinary setting
• Staff supervision & training

Skills

Essential

• Excellent communication skills both verbal and written
• Ability to work on own initiative and as part of a team.
• Self motivating
• Ability to work under pressure, highly organised, and working to deadlines
• Ability to manage and implement change
• Ability to influence and negotiate with medical, nursing and pharmacy colleagues
• IT literate
• Ability to recognise own limitations

Desirable

• Understanding of the skills required within aseptic services.
• Project management skills

Knowledge

Essential

• Knowledge of GCP and clinical trials IMP management.
• Knowledge of NHS cancer strategies.
• Clinical pharmacy skills. Medicines Reconcilliation and Medicines Optimisation.

Desirable

• Knowledge and understanding of phase 1 clinical trials.

Values

Essential

• Ability to demonstrate the organisational values and behaviours

Other

Essential

• Excellent communication & interpersonal skills, including influencing skills.
• Excellent organisational skills
• Ability to prioritise work effectively
• Ability to lead and motivate others
• Ability to train and develop staff

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.

Certificate of Sponsorship

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).