Senior Assistant Technical Officer Clinical Trials

Job overview

As a member of the Clinical Trials team, you will work closely with other members of the team to ensure that Christie patients have access the latest development of oncology/haematology investigational medicines.  The Pharmacy Department are also supporting the large-scale collaborative project alongside several research partners and have strong links with the University of Manchester.

We are wishing to recruit individuals who are enthusiastic, committed, adaptable and flexible to our team. Now is an exciting time to join the Trust as our clinical trial activity continues to grow due to the expansion of phase I experimental cancer medicines and advanced therapies investigational medicinal products (ATIMPs). If you are passionate, keen, and interested in making a positive contribution to the care of cancer patients involved in clinical trials, we want to hear from you.

We welcome applicants who have no previous pharmacy experience or do not hold the required qualifications as it may be possible for you to undertake the NVQ Level 2 in Pharmacy Services as a Band 2 apprentice. You would then progress to a band 3 upon successful completion of the course.

Main duties of the job

Support all aspects of pharmacy requirements for medicinal products within the context of a clinical trial (handling, dispensing, drug accountability, administration, storage, disposal of medicinal products.

Provide support to ensure activities within the pharmacy department are managed in accordance with the International Conference of Harmonisation Good Clinical Practice Guidelines (ICH-GCP), Good manufacturing Practice (GMP), the Research Governance Framework for Health & Community Care (2001) and the Medicines for Human Use (Clinical Trials) Regulations 2004.

Please note: if you are appointed to the post at Band 2 with the requirement to undertake the Level 2 Pharmacy Services apprenticeship, the job description may differ in that some duties/responsibilities will be developed during the

training period and not expected from day one.

Detailed job description and main responsibilities

DUTIES AND RESPONSIBILITIES

Clinical trials

Check pharmacy files for missing data and organise, retrieve, and record data in a timely manner.

Ensuring clinical trial pre orders and vial allocations are turned around in a   timely fashion to prevent any delay in patient treatment.

Work with sponsor IVRS/IWRS for ordering, acknowledging orders.

Dispensing and preparation of medicines both IV and oral clinical trials in accordance with ICH GCP and study specific sops.

To provide support to other pharmacy staff in the dispensing of complex clinical trials.

Use computer-based data storage systems and IVRS/IWRS to record clinical trial activity

Assist pharmacy team in all areas of R&D 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.

To participate in the maintenance of pharmacy documentation where required.

Support regulatory compliance across all clinical research services within pharmacy.

To perform any other duties as requested by the line manager and/or director of pharmacy.

To be responsible for own continued personal and professional development through training and review with line manager.

GENERAL

Undertake daily housekeeping duties

Be fully aware of COSHH regulations, particularly in relation to health and storage of medicines. Be aware of the Cytotoxic Spill procedure in the event of an accident.

Report any complaints, incidents, or near misses on the departmental Incident report sheets.

Be fully aware of all departmental operational policies and carry out procedures in accordance with current legislation.

Comply with the Health & Safety at work Act.

Attend regular in house and Trust training sessions to ensure Continued Professional Development. Attend Trust & departmental Mandatory training

Participate in the extended hours of the department, leading to twelve hour and seven-day week departmental opening.

To be able to participate in Saturday working as required by the service.

To participate in the required bank holiday working rota.

The duties of the post may be varied with the agreement of the employee in accordance with the changing needs and practices of the department and organization.

The role should be discussed at least on an annual basis through the preparation of a personal development plan.

Training programme

The post holder will be expected to undergo further training that may be necessary to continue in this role. In the first instance this will be an in-house training programme.

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.