Detailed job description and main responsibilities

JOB SUMMARY

To take the lead in co-ordinating the technical aspects of clinical trial activities in clinical trials, ensuring compliance with standards of clinical trial management as outlined in NUH Trust Clinical Trials Policy, Guidelines for the Safe and Secure Handling of Medicines, relevant and applicable EU and UK legislation and the Research Governance Framework for Health and Social Care 2005.

The post holder will be based primarily at the QMC  campus but will be expected to attend meetings and work at City Campus to enhance the effectiveness of this role as appropriate.

KEY JOB RESPONSIBILITIES

1.      In conjunction with the Pharmacy Clinical Trial team (including specialist technicians and pharmacists), the Production Department team Quality Control and the NUH Research and Innovation department, assist in the delivery of a responsive clinical trials service, to ensure good clinical practice standards (GCP) and the needs of service users are met.

2.      With support and guidance from the Chief Technician Clinical Trials to lead on the day to day management of the clinical trials service in liaison with other Lead Clinical trial technicians

3.      To supervise and participate in the dispensing of clinical trials prescriptions and requisitions.

4.      To supervise and participate in the accuracy checking of clinical trial prescriptions and non–clinical trial prescriptions where a pharmacist has previously professionally screened the prescription or where a professional screen is not required.

5.      To supervise and participate in the appropriate, accurate and legible completion of Investigational Medicinal Products (IMPs) and Non Investigational Medicinal Products (NIMPs) accountability documentation.

6.      To review and update clinical trial documentation and procedures in liaison with the Production Department Management team, the Pharmacy Clinical Trial team and the Quality Control Department to ensure a consistent approach.

7.      To assist the clinical trials pharmacists in the review and set-up of new clinical trials; review of amendments and updates to existing studies and dissemination to all relevant pharmacy staff to ensure compliance with protocols and procedures in line with GCP. Involving close working with Sponsor representatives on how research can be delivered within the Trust. This will include writing study specific dispensing procedures, liaison with the Production Management team, research staff and liaison with the ChemoCare team (where necessary).

8.      With supervision and support from the Specialist Clinical Trials Pharmacist take the lead on the day-to-day management of a portfolio of clinical trials from a pharmacy perspective and ensure GCP compliance on clinical trial delivery.

9.      To manage stock control of trial medicines in liaison with the Pharmacy Clinical Trial team, including ordering and receipt, monitoring of stock levels, reconciliation of returns, monitoring of expiry dates, investigation and rectification of discrepancies in accountability and ensuring appropriate storage conditions. To lead in ensuring that correct trials medication is available for manufacture in the designated pharmacy production unit in a timely manner, and that other associated medicines are ordered. 

10.  To supervise the upkeep of dedicated clinical trial storage areas, including temperature control and monitoring.

11.  To measure and monitor all aspects of the clinical trial service on a regular basis liaising with the Information Technology and Finance administrators as needed.

12.  To assist in the induction and training of new pharmacy staff in clinical trial services and where necessary, nursing and medical research staff to ensure compliance with clinical trials protocols and procedures.

13.  To have responsibility for line managing dedicated staff, to ensure these staff are inducted appropriately and complete all necessary training, host their yearly appraisal conversations, undertake sickness monitoring and performance reviews if necessary.

14.  To support the Clinical Trials Finance and Admin Officer to ensure income accrued by clinical trial activity is calculated, requested and recorded according to standard procedures. To review study specific trackers and to provide study specific knowledge and advice where necessary.

15.  To support the Principal Pharmacist – Research and Innovative Treatments and the Chief Pharmacy Technician – Clinical trials in preparation for and during clinical trial audit by Sponsors and MHRA inspections

16.  To undertake project work, e.g. review of service or standards, as required providing data with which to develop the service or/and implement change as appropriate.

17.  To liaise with teams within pharmacy, the NUH Trust Research and Innovation Directorate and other NHS Trusts, and trial investigators, their research delivery team representing a sponsoring organisation or personnel from national and local clinical research networks, when necessary and appropriate.

18.  To host sponsors representatives when they visit the clinical trials department to perform monitoring visits, site initiation visits and close down visits for example. To provide them with the required documents and to ensure they are accompanied and supported during their visit to site.

19.  In liaison with R&I and following clinical trial procedures oversee and support the at the end of a study with study close down and the archiving of essential trial documentation in line with national guidance.

20.  To undertake a regular operational commitment in the in-patient dispensary/satellites within NUH (either at QMC or City) in order to maintain competencies and demonstrate fitness to practice as a registered pharmacy technician. Responsibilities to include dispensing, (including cytotoxic and controlled drugs), accuracy checking (including cytotoxic and controlled drugs), assist with dispensary flow and utilisation of the NUH pharmacy computer system for stock management and labelling purposes.

GENERAL DUTIES

in addition to the key job responsibilities detailed in this job description all employees at Nottingham University Hospitals NHS Trust are expected to comply with the general duties detailed below:

1.      To participate as an appraiser and appraisee in the departmental individual professional development review, supporting and working towards identified objectives and training requirements in order to maintain and continuously develop performance for the benefits of service and patient care.
2.    Shifted and bank holiday duties: To participate in departmental weekend, bank holiday and late duty working as required. At the time of advertising, the weekend rota encompasses 2 half-day shifts every 4/5 weeks at the city campus or 1 full day shift every 4 weeks at the QMC campus.  In addition, the post holder will participate in a system of flexible shifts to facilitate NUH pharmacy opening times.

3.      To participate in the interviewing and selection of new staff for the Pharmacy department.

4.      To adhere to all relevant legislation, such as the Medicines Act, GMP, GLP, GCP, H&S, COSHH, European Directive 2001/20/EC etc. and to Trust policies.

5.      To be accountable for own professional practice at all times, in accordance with the Code of Ethics of the Royal Pharmaceutical Society of Great Britain.

6.      To maintain confidentiality in all work areas.

7.      To undertake annual mandatory training e.g. manual handling, fire, security, basic life support etc.

8.      To undertake any other duties that may reasonably be required as agreed with senior staff.