Job responsibilities
Clinical trials duties/responsibilities:
1. Act as nominated pharmacy lead and subject matter expert to a defined group of research teams and be responsible for all aspects of pharmaceutical input relating to the prescribing, handling, dispensing, administration, storage and disposal of medicinal products related to delegated clinical trials in accordance with. This will involve interpreting complex oncology/haematology clinical trial documents, liaising with external agencies and organisations, and coordinating pharmacy activities to ensure all activities are conducted in compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004, principles of GCP (Good Clinical Practice), Good Manufacturing Practice (GMP).
2. Be responsible for the evaluation of complex clinical trial protocols and supporting documents for designated disease groups, considering implications within pharmacy (capacity, safety and resources) and providing timely feedback to the research and external sponsor teams.
3. Provide highly-specialist clinical trial and pharmaceutical advice and training on the conduct of CTIMPs to pharmacy, nursing, medical and R&I teams and patients. Assess study requirements and negotiate solutions, as required, resolve pharmaceutical issues with the research and sponsor teams.
4. Develop and maintain systems and processes to ensure 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. To monitor, document and advise on the financial implications of designated studies to the Lead Pharmacist for Clinical Trials, Research Division, finance team and Director of Pharmacy.
6. Maintain systems and processes to ensure that all trial-related activity is conducted in accordance with the Medicines for Human Use (Clinical Trials) Regulations 2004, principles of GCP (Good Clinical Practice), Good Manufacturing Practice (GMP) and all other regulatory/local requirements.
7. Promote regulatory compliance across all clinical research services within pharmacy
8. To effectively communicate highly complex and potentially highly sensitive information to all service users, in a manner that is consistent and appropriate with their level of understanding. To explain highly complex issue sand contribute to the decision-making process balancing the interests of the service users and the Trust accordingly.
9. Prepare comprehensive risk assessments related to the Control of Substances Hazardous to Health, and advise other members of the pharmacy, nursing, medical teams accordingly in relation to storing, handling, labelling and product evaluation for all new products used in clinical trials.
10. To assist the clinical trials pharmacist team with prescription proforma development for new and amended clinical trial regimens, completing any pharmacy-specific documentation before a trial opens for recruitment.
11. To lead on internal or external audits related to clinical trials, including sponsor initiated and MHRA audit.
12. To participate in departmental, Trust and National risk management schemes such as error reporting systems and intervention monitoring.
13. Report to the Lead Pharmacist for Clinical Trials on all issues related to clinical trial activity within department.
14. Provide written reports on activity, regulatory compliance and financial positions to pharmacy and R&I staff as required.
15. Act as a subject matter expert on the pharmaceutical management of clinical trials for staff within the Research Division. To be responsible for providing formal advice and ongoing specialist training sessions for Christie staff on all pharmaceutical aspects of new and existing trials.
16. To continuously update highly specialist knowledge relating to clinical trials, including national legislation and guidance and Trust initiatives, and facilitate the updating of all pharmacy staff on issues related to clinical trials.
Christie Research Outreach duties/responsibilities:
1. Liaise with the Lead Pharmacist for Clinical Trials and Research Division operational leads to develop and deliver a strategy for the pharmaceutical management of clinical trials at Christie Outreach sites, and report this to the Director of Pharmacy and Divisional Board in the absence of the Lead Pharmacist.
2. Operationally plans, develops and monitors pharmacy services for clinical trials at Christie Outreach sites, ensuring the safe, clinically effective management of medicines and compliance with current legislation, professional standards and organisational objectives.
3. Work with the Lead Pharmacist to agree standards and key performance indicators (KPIs) with relevant section heads and be responsible for collecting and reporting KPIs to the R&I division as agreed
4. Responsible for developing of strategies for IMP management risk assessing and mitigation strategies of clinical trials at Christie Outreach centres.
5. Liaise with pharmacy, clinical teams and QA departments at Christie Outreach sites to support the development of expertise in clinical trials.
6. Assist the Lead Pharmacist for Clinical Trials in the assessment of the clinical trials pharmacy services in all relevant areas of the department and reporting these assessments appropriately.
7. Assist the Lead Pharmacist for Clinical Trials in ensuring that the Pharmacy Clinical Trials team meets service needs, including in the support of Christie Research Outreach services. This may include carrying out comprehensive risk assessments, vendor assessments, developing standard operating procedures, inter- and intra-departmental negotiation concerning facilities, resources, capacity planning, and financial arrangements in the operational management of clinical trials of investigational medicinal products (CTIMPs).
8. Development and review standard operating procedures or policies for the safe use and implementation of pharmacy clinical trials at Christie Outreach sites. Lead on ensuing compliance through departmental audit and deliver training required.
9. Identifies and manages risk issues (particularly those relating to clinical trial medication) across Christie Outreach pharmacy services and escalating to the Lead Pharmacist for Clinical Trials, R&I division and QA team as appropriate. Ensure that systems are in place and incidents are investigated, with appropriate corrective action undertaken.
10. To ensure the correct and safe storage of medicines for delivery to Outreach centres, including security.
11. Lead on service improvement initiatives and take leadership in decision making where required.
12. Act as a resource for staff within the Research Division and Christie Research Outreach services, providing formal advice and specialist training sessions where needed.
13. The ability to travel occasionally to Christie Outreach sites, per the roles requirements.
General responsibilities/requirements:
1. To manage and resolve any clinical or dispensing queries concerning clinical trial medications to maintain a high standard of patient care, assisting technical staff with day-to-day queries, as appropriate.
2. To participate in departmental rotas for ward cover, screening and accuracy checking of highly complex clinical trial prescriptions, including the provision of specialist advice and support for the provision of complex anticancer regimens to the highest safety and quality standards
3. Have a full awareness of the intrathecal chemotherapy policy. Follow local, Trust and national guidelines for safe medicines practice.
4. To identify issues and problem solve whilst also developing and implementing solutions in conjunction with colleagues and other teams in the Trust and with external partners.5. To attend relevant MDT meetings, relevant specialist pharmacy groups and contribute to meetings relevant to the designated disease group as appropriate. To represent the pharmacy service at appropriate divisional meetings on request.6. To support the development of the Electronic Prescribing process across the Trust.7. Facilitate effective communication about relevant pharmacy issues to clinicians and senior managers and the identification of opportunities for development of pharmacy services to match identified services and care needs.8. To identify and report any systemic or preventable errors associated with medicines within the Cancer Centre Services Division, and facilitate learning.9. To act as a mentor and role model to junior pharmacists, pharmacy technicians and assistant technical officers.10. Complete annual appraisals for direct reports, in line with Trust guidelines and according to agreed timetable.
11. To participate in Continuing Professional Development, ensuring relevantknowledge and skills are kept up to date and meeting the professional requirement of the General Pharmaceutical Council.
12. To participate in mandatory training in line with the Trust and departmentalrequirements. To participate in all departmental rotas, extended hours weekend and Bank Holiday working and the emergency on-call pharmacy service, asrequired.
13. To actively participate in pharmacy practice development and research projects.
14. To develop positive working relationships with all NHS staff in all areas ofwork to ensure the safe and effective use of medicines and resolution of identified pharmaceutical care issues.
15. To behave in a manner that is in accordance with the professional standards set by the General Pharmaceutical Council. Demonstrates the agreed set of values and accountable for own attitude and behaviour.
