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Communication & Relationship skills

• Communicate professionally with staff on all levels, both internal and external relating to trial activities, regarding information which may be confidential and sensitive in nature.
• Communicate with sponsors for monitoring appointments and meetings verbally and in written format.
• Liaise with other health professionals within research teams providing advice and support pertaining to clinical trial pharmacy issues.

Analytical & Judgemental skills

• Exercise judgement when dealing with all enquires. Assess and manage query if possible, referring to the Lead clinical trials technician, senior trials technicians or pharmacists as appropriate.
• Check pharmacy files for missing data and organise, retrieve, and record data in a timely manner.

Planning and organisational skills

• Co-ordination of monitoring visit requests, ensuring availability of staff and workspace.
• Ensuring clinical trial pre orders and vial allocations are turned around in a timely fashion to prevent any delay in patient treatment.
• Support co-ordination of study set-up with the clinical trials pharmacist in a timely manner.

Physical skills

• Work with sponsor IVRS/IWRS for ordering, acknowledging orders, dispensing update calls for Investigational Medicinal Products.
• Supports the generation of worksheets and labels for Investigational Medicinal Products for both Aseptics and the Dispensary.

Responsibility Patient/Client Care

• Dispensing and preparation of medicines for clinical trials in accordance with departmental and study specific SOPs
• To act as a certified accredited checking technician, supporting the final check of clinical trial prescriptions.
• To provide support to other pharmacy staff in the dispensing of complex clinical trials.
• Support and advise key staff accordingly in relation to handling, labelling, and dispensing for all new products used in clinical trials.
• Ensure all trial related reports and documentation are maintained within the timeframes defined by the sponsor.

Responsibility Policy & Service Development

• Follow all relevant policy and legislation (e.g., EU Directive)
• Prepare master worksheet and labels for approval by appropriate pharmacists using Sponsor supplied documents.
• Awareness of COSHH regulations in the safe handling and storage all clinical trial materials.
• Assists SATO, Student Technicians, and the CTA in ensuring supplies of Investigational Medicinal Product are ordered in a timely manner.

Responsibility Information Resources

• Use computer-based data storage systems and IVRS/IWRS to record clinical trial activity.
• Work with Microsoft office programmes, requiring standard software skills.
• Maintain individual patient treatment records on Trust based systems, ensuring information is up to date, accurate and complies with Data Protection Act.

Responsibility Research & Development

• Assist pharmacy team in all areas of R&I administration as required.
• Ensure all drug accountability for all clinical trials are processed accurately and in a timely manner ensuring drug accountability is up to date at the time of a monitoring visit, audits, and Inspections.
• Assists the ATO/CTA in maintenance of pharmacy documentation where required.
• Support regulatory compliance across all clinical research services within pharmacy.

Freedom to Act

• Post holder is expected to follow all relevant protocols, SOPs, and standard practice.
• Clinical Trials Team Leader is available as point of reference for any queries and will meet regularly with staff.
• Plan and organise own time and workload activity with prioritisation.

Physical, Mental and Emotional Effort

• Long periods of time spent using screens and keyboard to input information
• Prolonged concentration is regularly required e.g., when entering new products onto the computer system to produce worksheets and labels.

Working Conditions

• The Trust operates a range of policies, e.g. Human resources, clinical practice (available on the Trust Intranet). All Trusts employees must observe and adhere to the provisions outlined in these policies.
• Participate in the extended hours of the department, if required. To be able to participate in weekend and bank holiday working as required by the service. This may be reviewed and altered depending on the service demands.
• Ability to demonstrate the organisational values and behaviours and the positive working relationship policy.