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Detailed job description and main 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which include environmental monitoring, protocols, pharmacy manual, Investigational Brochure including archiving of outdated records and working practices are to the expected standards under GMP, ICH-GCP dispensing practice and the  research and governance framework.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 IMP’s 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 KPI’s (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.

Please see job description for further details