Senior Clinical Trials Technician

Guy's and St Thomas' NHS Foundation Trust; London; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading NHS Foundation Trust in London is seeking an Oncology Pharmacy Clinical Trials Pharmacist. This role involves managing and maintaining the Oncology Pharmacy Clinical Trials Portfolio, ensuring compliance with clinical guidelines, and training staff. Candidates should have a degree in Pharmacology, experience in clinical trials, and excellent communication skills.

Qualifications

• Degree in Pharmacology or equivalent required.
• Experience in supervising staff and workload essential.
• Ability to write SOPs and prioritize tasks.

Responsibilities

• Manage the Oncology Pharmacy Clinical Trials Portfolio.
• Develop and maintain clinical trial documents and SOPs.
• Ensure compliance with regulations and training requirements.

Skills

SOP writing

Communication

IT skills

Team leadership

Pressure management

Education

Degree in Pharmacology or Pharmaceutical Science

Dispensing Assistant Qualification

GCP Training

Tools

EPIC Hyperspace

Willow Computer Systems

Job description

Job summary

1. To help manage, develop, organise and maintain the Oncology Pharmacy Clinical Trials Portfolio in conjunction with the Highly Specialist Clinical Trials Pharmacist, ensuring compliance with ICH GCP guidelines, The Research Governance Framework, the E.U Clinical Trials Directive and other relevant guidelines, regulations andpolicies.
2. To help manage the training and assessment of pharmacy staff undertaking Clinical trial work within OncologyPharmacy
3. Develop, review & revise policies, guidelines and procedures regarding clinical trials services
4. To write precise and concise standard operating procedures (SOPs) for each new clinical trial with respect to dispensing, final checking and procurement of Investigational Medicinal Products (IMPs) which are final checked by the Highly Specialist Clinical Trials Pharmacist.

Main duties of the job

To be responsible for the day-to day maintenance of the oncology pharmacy clinical trials portfolio.

Ensuring that all oncology pharmacy clinical trial files contain allnecessary documentation and are kept up todate

Preparing (and update as required) clear and accurate written dispensing procedures for dispensing staff for each clinical trial in accordance with International Conference for Harmonisation for Good Clinical Practice( ICHGCP) and each study's protocol

Preparing (and update as required) clear & accurate final checking procedures for rotational pharmacists in accordance with ICH GCP and each study's protocol

Prepare (and update as required) a clear and accurate written summary of each clinical trials protocol.

Create drug accountability records, patient I.D logs and other documents deemed necessary (where the study sponsor has not alreadyprovided)

Ensure that all files contain copies of all relevant regulatoryapprovals

Review oncology clinical trial documents prior to initiation of a new study, assess the suitability local documents and procedures relating to procurement, storage and dispensing of study medication and make recommendations for changes when appropriate.

Dispensing clinical trials

Manage the security & maintenance of all clinical trial drugs

Responsible for routine monitoring visits and 'close down' procedures for clinical trials

About us

As part of Kings Health Partners, the Oncology and Haematology Clinical Trials (OHCT) team is made up of ninety plus staff members consisting of Research Nurses, Clinical Trial Practitioners, Clinical Trial Coordinators and the Safety & Support Team at Guys' and St Thomas' NHS Foundation Trust. Within the OHCT Pharmacy team there is a mixture of pharmacists technicians and assistant.

We work closely with the oncology and haematology medical teams to recruit patients to our trials and to ensure patients are monitored closely throughout. We have a large portfolio of Phase II and III trials; which are split into teams for specific tumour groups. We also have a team dedicated to early phase trials and run weekly early phase clinics in the Clinical Research Facility. We attract commercial and non-commercial trials, ranging from interventional drug or radiotherapy trials to observational studies.

Our mission statement is 'Improving treatment choice, clinical care and outcomes for cancer patients through innovation, dedication and excellence in clinical trials'.

Job description

Job responsibilities

KeyRelationships

A list of staff the post holder will have regular contact with

Within Pharmacy: Principal Technician Oncology/Aseptic Services, Dispensary managers, Pharmacists and Technical staff.

Others: Research nurses, Investigators (Consultants), Junior Doctors and other research personnel. Representatives from the Pharmaceutical Industry, non-commercials research organisations and regulatory authorities.

Job description
Job responsibilities

KeyRelationships

A list of staff the post holder will have regular contact with

Within Pharmacy: Principal Technician Oncology/Aseptic Services, Dispensary managers, Pharmacists and Technical staff.

Others: Research nurses, Investigators (Consultants), Junior Doctors and other research personnel. Representatives from the Pharmaceutical Industry, non-commercials research organisations and regulatory authorities.

Person Specification

Knowledge/Qualifications

Essential

• Degree in Pharmacology , Pharmaceutical science or equivalent. Or NVQ Level 3 in pharmacy services.
• Dispensing assistant qualification or course will be required to be undertaken as per required timelines
• GCP Training

Desirable

• Registered as a Pharmacy Technician with the General Pharmaceutical Council
• MSC / Diploma

Previous Experience

Essential

• Previous evaluated experience of supervising staff and workload on a day-to-day basis
• Previous evaluated experience of participation in project and audit work
• Professional CPD as defined by General Pharmaceutical Council

Desirable

• Demonstrated experience of ability to appraise staff and set performance objectives

Skills

Essential

• Demonstrated ability to write SOPs
• Demonstrated ability to prioritise and organise routine daily, using own initiative, whilst supervising and leading a team
• Demonstrated ability to work under pressure accurately
• Demonstrated ability to communicate more complex and sensitive information effectively using clear written and spoken English to overcome barriers to understanding
• Demonstrated IT skills including: ? Email ? Word processing ? Spreadsheets Accurate data entry
• Demonstrated ability to clearly and accurately complete complex routine and non-routine documentation.

Desirable

• Demonstrate ability manage performance
• EPIC hyperspace / willow computer systems

Person Specification
Knowledge/Qualifications

Essential

• Degree in Pharmacology , Pharmaceutical science or equivalent. Or NVQ Level 3 in pharmacy services.
• Dispensing assistant qualification or course will be required to be undertaken as per required timelines
• GCP Training

Desirable

• Registered as a Pharmacy Technician with the General Pharmaceutical Council
• MSC / Diploma

Previous Experience

Essential

• Previous evaluated experience of supervising staff and workload on a day-to-day basis
• Previous evaluated experience of participation in project and audit work
• Professional CPD as defined by General Pharmaceutical Council

Desirable

• Demonstrated experience of ability to appraise staff and set performance objectives

Skills

Essential

• Demonstrated ability to write SOPs
• Demonstrated ability to prioritise and organise routine daily, using own initiative, whilst supervising and leading a team
• Demonstrated ability to work under pressure accurately
• Demonstrated ability to communicate more complex and sensitive information effectively using clear written and spoken English to overcome barriers to understanding
• Demonstrated IT skills including: ? Email ? Word processing ? Spreadsheets Accurate data entry
• Demonstrated ability to clearly and accurately complete complex routine and non-routine documentation.

Desirable

• Demonstrate ability manage performance
• EPIC hyperspace / willow computer systems

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the .

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. .

Additional information
Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the .

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. .

Employer details

Employer name

Guy's and St Thomas' NHS Foundation Trust
Address

Guys Hospital

Great Maze pond

London

SE1 9RT

Employer's website