Specialist Technical Officer Clinical Trials and - Plymouth, United Kingdom - University Hospitals Plymouth NHS Trust

University Hospitals Plymouth NHS Trust

Verified Company

Plymouth, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

An exciting opportunity has arisen for an enthusiastic and self-motivated band 4 Senior Assistant Technical Officer to work within the pharmacy clinical trials team here at University Hospitals Plymouth NHS Trust.

To undertake technical duties in the preparation of manufactured pharmaceuticals within the Pharmacy Production Services Unit to ensure all research products are prepared to a high standard as set out in study specific documents, standard operating procedures and appropriate guidelines.

You will work as a Senior Assistant Technical Officer within the clinical trials team who are committed to providing the highest quality of research and care for patients recruited to clinical trials.

You will be responsible for ensuring that trials run smoothly; this will include stock control, accurate record keeping and drug accountability of clinical trials, liaising within a multi-disciplinary team.

Preference will be given to internal Trust staff, as well as 'Priority' and 'At Risk' status including NHS at Risk staff throughout Devon who is able to display recent relevant experience as dictated by the Person Specification.

To work in all areas of the department in a training capacity and under supervision, to learn skills and knowledge, and to become aware of department policies and procedures.

To undertake general dispensary duties, in accordance with Standard Operating Procedures and within the legal framework

To assist in maintaining optimal stock levels within the dispensary, liaising with patients, colleagues and ward staff to ensure that immediate and future needs can be met.

To use the pharmacy computer system efficiently

To participate in departmental team meetings regarding procedures and practices.

CLINICAL TRIALS DUTIES

To provide effective communication with the R&D department, the research team, multidisciplinary team and various UK organisations and pharmaceutical companies.
To assist the Pharmacy Clinical Trials Manager in management of the pharmacy aspects of clinical trials involving Investigational Medicinal Products at Plymouth Hospitals NHS Trust to include initial trial set up. To review the protocol amendments and complete the appropriate amendment paperwork in preparation for review and approval of the Pharmacy Clinical Trials Manager as a part of the IMP management.
To coordinate the management of active clinical trials prepared in the Pharmacy Production Services to ensure all research products are prepared to a high standard as set out in study specific documents, standard operating procedures and appropriate guidelines.
In collaboration with the pharmacy clinical trials team to ensure accurate record keeping of drug accountability of all clinical trials (both written and computer records). To investigate and document any discrepancies to the appropriate sponsor's representative.
To contribute to the efficient stock control of all clinical trial products by undertaking regular stock checks to ensure sufficient (IMP/trial-specific) "in date" stock for current and new patients.
Be responsible for the return and subsequent storage and reconciliation of Clinical trials IMP in line with the relevant pharmacy research SOPs relating to efficient stock control, issue and return or safe disposal of drugs relating to clinical trial IMP.
To supervise the study trial monitoring and study close out visits ensuring that both the pharmacy site files are drug returns are prepared in advance. To monitor the storage of IMPs outside of pharmacy and report any deviations to the Pharmacy Clinical Trials Manager or Clinical Trials Pharmacist.
To respond quickly and appropriately to all enquiries and queries, directing to the most appropriate team member.
To ensure all staff use the pharmacy computer systems correctly in relation to Clinical Trials, that data is entered accurately from prescription forms or any other documentation used in the supply of Clinical Trial IMP and that data is stored and archived appropriately in accordance with local and regionally agreed guidelines.
To participate in the ordering and receipt of clinical trials products following trial protocols, study specific instructions and the departmental SOPs.
To work in accordance with GCP, GMP and GDP guidelines/department procedures reporting any deviations to the appropriate pharmacy clinical trials manager.
To monitor appropriate storage of all clinical trial products ensuring storage condition records and accurate expiry records for all clinical trial products are kept up to date and archived for future reference according to GCP, GMP Guidelines.
To ensure that pharmacy equipment is kept in a clean and usable condition.
To attend appropriate GCP training every two years.
To participate in the appraisal process and to undertake appropriate mandatory training.
To assist with training of the SATO/ATO and other pharmacy staff as required in dispensing clinical trials.