To manage and co-ordinate the pharmacy aspects of clinical trial activities across Northampton General Hospital NHS trust for studies involving medicine ensuring compliance with ICH-GCP guidelines, clinical trial regulations, the research governance framework and other relevant guidelines and policies.

To be accountable for the provision of proactive and dynamic pharmacy clinical trials service, ensuring safe systems of work are maintained, by preparation of procedures, IMP (investigative medicinal products) handing, including but not limited to receipt, storage, dispensing, transportation and destruction.

The post holder will work closely with the NGH research and innovation team and the Principal Investigators for the trials.

The post holder will facilitate clinical trials training within the pharmacy department.

To provide leadership and support to the pharmacy department and research and innovation team.

The post holder may be required to attend Trust level meetings and deputise for the Clinical Trials Pharmacist, to support the Advanced specialist Pharmacist Clinical Trials when required.

To work within the GPhC code of ethics and to actively participate in Continuing Professional Development.

Main duties of the job

To facilitate and co-ordinate the training of all Pharmacists and Pharmacy Technicians involved in clinical trials with regards to trial set up, dispensing, accuracy checking and day-to-day trial queries and monitoring their progress and ICH GCP dispensing practice.

To assist with ensuring all members of the pharmacy team who will be dispensing and checking trials including ASU staff have the appropriate GCP training and maintain their competency.

To accurately maintain the documentation for ongoing trials ensuring all records which include environmental monitoring, protocols, pharmacy manual, Investigational Brochure including archiving of outdated records and working practices are to the expected standards under GMP, ICH-GCP dispensing practice and theresearch and governance framework.

Undertake and ensure effective line management of senior pharmacy technician (band 5) ensuring they are clear in their role and has an appraisal/PDR with a development and training plan which is consistent with trust values.

To take an active role in supporting Clinical Governance agenda both within the pharmacy department and the trust.

About us

Northampton General Hospital is one of the largest employers in the area and we are on an exciting journey. All of our divisions are committed to doing things better, with more efficiency as we update, modernise, and advance. We have also entered into a Group Model with neighbouring Kettering General Hospital NHS Foundation Trust and become University Hospitals of Northamptonshire.

Our Excellence Values

Compassion

Accountability

Respect

Integrity

Courage

We want to recruit the best people to deliver our services across the University Hospitals of Northamptonshire and help to unleash everyone's full potential. As an organisation, we value how we communicate and promote our vacancies to all communities.

We are a Defence positive trust, supporting our reservists, veterans, spouses and partners.

The Hospital Group encourages applications from people who identify from all protected groups, especially those from BAME, Disabled and LGBTQ+ backgrounds as these are underrepresented in our hospitals.

We understand that we need to work with colleagues from diverse backgrounds and make sure the environment they work in is inclusive and collaborative.

We have active Networks that promote and support colleagues from all backgrounds.This ensures everyone feels supported and has a sense of belonging working for Kettering and Northampton General Hospitals.

Job description

Job responsibilities

To facilitate and co-ordinate the training of all Pharmacists and Pharmacy Technicians involved in clinical trials with regards to trial set up, dispensing, accuracy checking and day-to-day trial queries and monitoring their progress and ICH GCP dispensing practice.

To assist with ensuring all members of the pharmacy team who will be dispensing and checking trials including ASU staff have the appropriate GCP training and maintain their competency.

To be responsible for preparing and maintaining dispensing and accuracy checking guidelines/ procedures for clinical trials within Pharmacy.

To accurately maintain the documentation for ongoing trials ensuring all records which include environmental monitoring, protocols, pharmacy manual, Investigational Brochure including archiving of outdated records and working practices are to the expected standards under GMP, ICH-GCP dispensing practice and the research and governance framework.

To be responsible for the ordering, receipt and storage of pharmaceuticals including IMPs and sundries required to support clinical trial work, including accurate record keeping and drug accountability.

To be responsible for monitoring stock levels of clinical trial supplies and expiry dates checks

To be responsible for the closing of completed trials and facilitating the archiving of records.

To provide a prompt, responsive service to meet the pharmaceutical needs of the clinical trials undertaken at Northampton General Hospital NHS Trust.

To act as a named contact for the pharmaceutical companies (sponsors) wishing to sponsor trials at NGH.

To review research/trial protocols, attending set up meetings, working closely with the Advanced Specialist Pharmacist for Clinical Trials, Clinical Research Associates and Research Nurses and identifying issues and negotiating to ensure resolution.

Ensure there are safe, efficient, and effective systems and procedures in place for the supply and documentation of all clinical trial supplies and returns and take required action in the event of stock discrepancies where necessary.

To work closely with the Research and Innovation department and the lead Clinical trials Pharmacist to deliver the clinical trial service by communicating effectively with patients and staff.

To meet with the inspection requirements of trial facilitators and study auditors.

To act as the liaison between sponsoring bodies, the appropriate directorate clinical pharmacist, the clinical trials pharmacist, commercial contacts, ASU, the PI and their research team.

To act as a source of trial set up expertise, advising on trial documentation, and label design to reduce the risk of errors.

To prioritise and co-ordinate the day-to-day smooth running of clinical trials in all areas of pharmacy including the dispensary and the ASU.

To assess non-pharmacy storage areas prior to approval to store IMPs and audit these areas in conjunction with the advanced clinical trials pharmacist on a routine basis.

To liaise with dispensary colleagues to ensure timely dispensing and checking of clinical trials which will include participating in dispensing and checking of trials.

Ensuring the dispensing of IMP is carried out efficiently, safely, and accurately in accordance with NGH clinical trials procedures incorporating GCP.

To review the NGH clinical trials fee structure in collaboration with the Advanced clinical trials pharmacist.

To prepare monthly KPIs (including for the Pharmacy management Board) and reporting of Pharmacy research activities to the R& I division thus enabling the invoicing and retrieval of pharmacy fees.

To help the Advanced Clinical Trials pharmacist to review and design all IMP related prescriptions on the Chemocare electronic prescribing system.

To support the preparation for audits and inspections by the regulatory authorities and assist and lead as necessary, pharmacy clinical trial self-inspection plans and address any identified issues promptly.

Management

Undertake and ensure effective line management of senior pharmacy technician (band 5) ensuring they are clear in their role and has an appraisal/PDR with a development and training plan which is consistent with trust values.

To ensure monies are claimed with respect to both commercial and investigator led clinical trials.

To negotiate pharmacy costings as per the NIHR costing template for commercial trials and ensure all funds are regularly obtained for both commercial and non-commercial trials.

To deputise for the Advanced Pharmacist clinical trials, by participating in multidisciplinary team meetings with clinical research associates for both commercial and non-commercial trials as needed.

To highlight resource issues to meet the needs of the service taking into consideration staffing issues within the department.

Clinical Governance

To take an active role in supporting Clinical Governance agenda both within the pharmacy department and the trust.

To participate in the investigations of incidents or complaints regarding medicines and where appropriate complete incident forms in line with the trust policy.

To maintain appropriate standards of service and safety to comply with the trust Medicine Policy to ensure safe and effective handling of medicines within the trust.

Other

To develop and implement standard SOP in relation to clinical trials and new legislation as standard documentation for NGH thereby to continually improve the quality of the clinical trials service.

To provide basic training for NVQ pharmacy technicians, pharmacy technicians, trainee pharmacists, and for new and existing members of the pharmacy team

To initiate and maintain pharmacy study files so as to ensure appropriate members of the pharmacy staff can clinically assess, dispense, check and counsel patients on the IMP.

To provide basic training in the dispensing and checking of clinical trials to ensure safe working practices are adhered to whilst complying with relevant SOPs.

To continue in CPD and identify a personal development plan through this CPD and an annual performance review.

To develop appropriate skills in accordance with departmental/professional bodies requirements

To participate in accreditation/re-accreditation scheme for technical checking of dispensed items.

Participation in the late night, weekend and bank holiday rota as required by the service needs of the pharmacy department.

To participate in the final release of aseptically reconstituted IMPs as required by the service.

To support equality and value diversity within the team and the service

To carry out any other reasonable duties as required by the line manager

Person Specification

Educations, Training and Qualifications

Essential

• Educated to NVQ level 3 in pharmacy services level or equivalent level of education, training or experience
• Registered Pharmacy Technician
• Accuracy checking qualification or willing to work towards accreditation.
• Further formal training/development in clinical trials.

Desirable

• NVQ A1 Assessor

Knowledge and Experience

Essential

• Understanding of GMP
• Experience of GCP/setting up clinical trials
• Experience of final checking
• Experience of training and supervising staff
• Experience of working in Clinical Trials and the management of IMP's
• Multidisciplinary team working

Desirable

• Knowledge of practice in hospital Aseptic Services

Skills

Essential

• Proven ability to communicate effectively in a courteous and professional manner
• Good organisational, planning, time management, problem solving and prioritisation skills
• Good IT skills, good knowledge of MS Office
• Ability to work under pressure to tight deadlines and to prioritise workload
• Ability to identify and resolve problems
• Ability to work as part of a team as well as own initiative.
• Attention to detail and a high degree of accuracy

Employer details

Employer name

Northampton General Hospital

Address

Northampton General Hospital

Cliftonville

Northampton

NN1 5BD

Any attachments will be accessible after you click to apply.

265-6472958