Clinical Trials Assistant

Worcestershire Acute Hospitals NHS Trust; Worcester; On-site; GBP 22,000 - 26,000; Full time

Job summary

A leading healthcare provider in Worcester is seeking a Clinical Trials Assistant to support their Oncology Team. The role involves assisting with patient studies, data collection, and performing a variety of clinical duties. Candidates should possess essential skills in communication, attention to detail, and a background in healthcare. The position offers opportunities for training and career development in a reputable institution.

Benefits

Flexible working hours

Professional development opportunities

Comprehensive training programs

Qualifications

• Experience working within healthcare.
• Ability to accurately transcribe data.
• Ability to follow guidelines and protocols.

Responsibilities

• Support identification and management of patients in research studies.
• Assist with data collection and clinical tasks.
• Maintain accurate documentation and patient records.

Skills

Effective written and oral communication skills

Meticulous attention to detail

Computer literacy in MS Office

Education

English and Maths GCSE, or equivalent

Level 3 qualification/s, e.g. A' levels, NVQ

Job description

Job summary

We have an exciting and new role in our Oncology Team for a Clinical Trials Assistant.

Do you have a meticulous attention to detail, want to assist inthe development of new and innovative ways of treating our patients? Then thisis the role for you.

You will support a busy team working on clinical studies acrossa variety of specialities within all three sites in our trust.

This role will give you balance of office and clinical work. Youwill support patients in the outpatient and inpatient setting. Whilst alsoensuring high quality data is submitted to our clinical trials units in atimely manner.

Main duties of the job

This role is ideal if you are looking to expand your knowledgein a variety of settings within our trust.

You will carry out a variety of clinical duties, such asphlebotomy, taking patients observations, such as, BP, Temperature and pulsereadings. You will work alongside all members of the research teams, such asconsultants and nurses to ensure study protocols are followed and data iscollected at the right timepoints for our patients

About us

Worcestershire Acute Hospitals NHS Trust is a largeacute and specialised hospital trust that provides a range of local acuteservices to the residents of Worcestershire and more specialised services to alarger population in Herefordshire and beyond.

The Trust operates hospital-based services fromthree sites in Kidderminster, Redditch and Worcester

Our workforce is more than 7,000 strong, and ourcaring staff are recognised as providing good and outstanding patient-centredcare. You could be one of them.

We are committed to recruiting the best people towork with us. Our values, which we ask all staff to demonstrate, underpin oureveryday work and remain firmly at the heart of all we do.

Being open and honest

Ensuring people feel cared for

Showing respect to everyone

We are proud to have achieved Timewiseaccreditation - this means we are committed to embedding flexible workingwithin our organisation as a flex positive employer.

DBS Checks and Costs

Any applicants who are offered posts requiring aDBS check as part of their employment check will have the cost of this check(at the current rate) deducted from their salary. Please see link in SupportingInformation section for more details on DBS checks and costs.

Job description

Job responsibilities

Key Working Relationships

Internal:

Departmentalcolleagues

LeadResearch Nurse

Headof Research Operations

Research Management Team

Research Delivery Teams

ClinicalTeams

Support Departments

External

Patientsand their relatives/carers/significant others

ResearchSponsor Organisations

ClinicalTrials Units / Universities

Pharmaceuticalcompanies / Contract Research Organisations

NIHRResearch Delivery Network

Herefordshire and Worcestershire ResearchConsortium

Partner Organisations

Other External Research Teams

Risk Assessment:

Manualhandling activities

Exposureto bodily fluids and exposure to high noise levels

Itmay also involve exposure to challenging behaviour

Workswith display screen equipment for prolonged periods

Job Purpose:

Weare committed to supporting research that is relevant and accessible to ourpatients. Through clinical research we can assess the efficacy of newmedication, diagnostics, and treatment regimes. This helps to build theevidence for new approaches to improve patient care

TheClinical Trials Assistant will support the Research Delivery Team in theidentification, recruitment and management of patients participating in researchstudies. The post-holder will help with data-collection, undertake specifiedclinical and laboratory tasks, and provide administrative support for researchstudies.

Thedepartment is involved in a range of clinical studies including life changingoncology and haematology trials, internationally recognised midwifery, renaland surgical studies, and many more. You will have the opportunity to getinvolved with a range of these, having direct contact with patients, carers andstaff.

KeyDuties

Clinical

Screen trust systems toidentify patients who may be eligible for research studies

Receive consent from patients intoresearch studies, under direction, and with appropriate training, in accordancewith GCP

Randomise patients intodifferent trial arms

Organise patient appointmentsand book research-specific investigations and procedures

Under supervision or after appropriatetraining, undertake clinical procedures required for research studies,including but not limited to; blood pressure recording, heart and respiratoryrate, height, weight and BMI assessment, collection of blood and urine samples,measurement of hip/waist circumference

Report all findings from clinicalprocedures to the research delivery team, and accurately document as advised bythe team in appropriate patient records, research files, logs, CRFs anddatabases

Provide ongoing assessment ofparticipants clinical condition liaising with relevant clinicians asappropriate, e.g. if patient condition alters

Process research participant samplesaccording to clinical trial protocols such as processing of blood samples,preparing samples for storage or shipment, and arranging couriers for safe andtimely transport of research samples

Collect prescriptions and liaise withpharmacy to coordinate trial medication

Explain and distribute researchparticipant questionnaires, diaries and the NIHR Participants in ResearchExperience Survey

Communicate sensitive information topatients

Provide ongoing information to patientsregarding their participation in research studies in writing, by telephone, andby e-mail

Identify and report any adverse eventsand reactions in accordance with the study protocol

Contribute to patientand public involvement and engagement activities

Administrative

Workwith the multi-disciplinary team to conduct feasibility assessments for newresearch studies

Assistthe research team in administrative duties for study set-up, initiation,maintenance, study

closure,and archiving

Workwith the Research and Innovation team to ensure compliance with regulatoryrequirements

Set up and maintainstudy site files, electronic files and other documents as needed for studies

Create digital patienttracking systems, e.g. using Excel

Assistin the entry of accurate and timely documentation of data into participant CaseReport Forms

Assistwith the resolution of raised data queries

Atall times ensure clear, accurate records are maintained by the research team

Plan,organise, prepare and participate in monitoring visits and audits

Update researchmanagement databases, including EDGE

Ensurethat patient identifiable records for research studies are stored according toInformation

Governance policies

Assistwith maintenance / ordering of research and office supplies

Coordinate anddisseminate amendments including preparation of any updated paperwork

Liase with trial unitsand commercial sponsors to coordinate trial activities

Maintain financialinformation and patient records to allow payments to be made

Handle petty cash andtravel expense claims for patients

Attend local andnational meetings as required

Record relevant meetingnotes, minutes and actions, and circulate these appropriately

General administrativeduties including answering thetelephone, answering queries, managing the research email inbox

Maintain awareness ofkey performance indicators and next steps to achieve them

Provide cover to othermembers of team as relevant to role

Liaise with otherdepartments for equipment maintenance, calibration and repair

Training and Education

As part of this role youwill receive the following training:

Trust Induction

CREATE training(Clinical Research Explained)

Improving Healthcarethrough Clinical Research MOOC

Clinical skillstraining, including phlebotomy

Good Clinical Practicetraining

Data Quality inResearch training

Informed Consenttraining competency

Site File Managementtraining

Case Report Form (CRF)completion training

EDGE training

Amendments training

Archiving training

iPROC system training

Regular performancedevelopment reviews

General Duties

Travelling betweensites is an essential part of this role

Any other duties as may be agreed in the course of undertaking thisrole, in accordance with the grade and nature of the post

Job description
Job responsibilities

Key Working Relationships

Internal:

Departmentalcolleagues

LeadResearch Nurse

Headof Research Operations

Research Management Team

Research Delivery Teams

ClinicalTeams

Support Departments

External

Patientsand their relatives/carers/significant others

ResearchSponsor Organisations

ClinicalTrials Units / Universities

Pharmaceuticalcompanies / Contract Research Organisations

NIHRResearch Delivery Network

Herefordshire and Worcestershire ResearchConsortium

Partner Organisations

Other External Research Teams

Risk Assessment:

Manualhandling activities

Exposureto bodily fluids and exposure to high noise levels

Itmay also involve exposure to challenging behaviour

Workswith display screen equipment for prolonged periods

Job Purpose:

Weare committed to supporting research that is relevant and accessible to ourpatients. Through clinical research we can assess the efficacy of newmedication, diagnostics, and treatment regimes. This helps to build theevidence for new approaches to improve patient care

TheClinical Trials Assistant will support the Research Delivery Team in theidentification, recruitment and management of patients participating in researchstudies. The post-holder will help with data-collection, undertake specifiedclinical and laboratory tasks, and provide administrative support for researchstudies.

Thedepartment is involved in a range of clinical studies including life changingoncology and haematology trials, internationally recognised midwifery, renaland surgical studies, and many more. You will have the opportunity to getinvolved with a range of these, having direct contact with patients, carers andstaff.

KeyDuties

Clinical

Screen trust systems toidentify patients who may be eligible for research studies

Receive consent from patients intoresearch studies, under direction, and with appropriate training, in accordancewith GCP

Randomise patients intodifferent trial arms

Organise patient appointmentsand book research-specific investigations and procedures

Under supervision or after appropriatetraining, undertake clinical procedures required for research studies,including but not limited to; blood pressure recording, heart and respiratoryrate, height, weight and BMI assessment, collection of blood and urine samples,measurement of hip/waist circumference

Report all findings from clinicalprocedures to the research delivery team, and accurately document as advised bythe team in appropriate patient records, research files, logs, CRFs anddatabases

Provide ongoing assessment ofparticipants clinical condition liaising with relevant clinicians asappropriate, e.g. if patient condition alters

Process research participant samplesaccording to clinical trial protocols such as processing of blood samples,preparing samples for storage or shipment, and arranging couriers for safe andtimely transport of research samples

Collect prescriptions and liaise withpharmacy to coordinate trial medication

Explain and distribute researchparticipant questionnaires, diaries and the NIHR Participants in ResearchExperience Survey

Communicate sensitive information topatients

Provide ongoing information to patientsregarding their participation in research studies in writing, by telephone, andby e-mail

Identify and report any adverse eventsand reactions in accordance with the study protocol

Contribute to patientand public involvement and engagement activities

Administrative

Workwith the multi-disciplinary team to conduct feasibility assessments for newresearch studies

Assistthe research team in administrative duties for study set-up, initiation,maintenance, study

closure,and archiving

Workwith the Research and Innovation team to ensure compliance with regulatoryrequirements

Set up and maintainstudy site files, electronic files and other documents as needed for studies

Create digital patienttracking systems, e.g. using Excel

Assistin the entry of accurate and timely documentation of data into participant CaseReport Forms

Assistwith the resolution of raised data queries

Atall times ensure clear, accurate records are maintained by the research team

Plan,organise, prepare and participate in monitoring visits and audits

Update researchmanagement databases, including EDGE

Ensurethat patient identifiable records for research studies are stored according toInformation

Governance policies

Assistwith maintenance / ordering of research and office supplies

Coordinate anddisseminate amendments including preparation of any updated paperwork

Liase with trial unitsand commercial sponsors to coordinate trial activities

Maintain financialinformation and patient records to allow payments to be made

Handle petty cash andtravel expense claims for patients

Attend local andnational meetings as required

Record relevant meetingnotes, minutes and actions, and circulate these appropriately

General administrativeduties including answering thetelephone, answering queries, managing the research email inbox

Maintain awareness ofkey performance indicators and next steps to achieve them

Provide cover to othermembers of team as relevant to role

Liaise with otherdepartments for equipment maintenance, calibration and repair

Training and Education

As part of this role youwill receive the following training:

Trust Induction

CREATE training(Clinical Research Explained)

Improving Healthcarethrough Clinical Research MOOC

Clinical skillstraining, including phlebotomy

Good Clinical Practicetraining

Data Quality inResearch training

Informed Consenttraining competency

Site File Managementtraining

Case Report Form (CRF)completion training

EDGE training

Amendments training

Archiving training

iPROC system training

Regular performancedevelopment reviews

General Duties

Travelling betweensites is an essential part of this role

Any other duties as may be agreed in the course of undertaking thisrole, in accordance with the grade and nature of the post

Person Specification

Qualifications

Essential

• English and Maths GCSE, or equivalent
• Level 3 qualification/s, e.g. A' levels, NVQ, etc

Desirable

• Computer Literacy Course, e.g. ECDL, or other experience or qualification
• ICH GCP (Good Clinical Practice)

Experience

Essential

• Experience working within healthcare
• Experience of working with the public or people form a range of backgrounds

Desirable

• Knowledge of healthcare research
• Experience working within the NHS

Skills/Knowledge

Essential

• Effective written and oral communication skills
• Computer literacy within a range of applications (including basic keyboard skills, MS Office)
• Understand the importance of confidentiality, dignity and respect in relation to both staff and patients
• Ability to accurately transcribe data from one source to another (e.g. written / electronic system onto paper / electronic report)
• Able to concentrate for long periods of time
• Meticulous attention to detail and quality
• Able to follow instructions, guidelines, policies and standards to provide a safe and effective service to others
• Able to work autonomously and organise themselves to manage own workload

Desirable

• Familiarity with medical or scientific terminology
• Venepuncture
• Laboratory skills

Personal Qualities

Essential

• Team player and supportive of colleagues, demonstrating civility and respect to colleagues and patients at all times
• Passionate about research and innovation and improving patient care
• Professional attitude, diplomatic and calm under pressure
• Able to demonstrate a commitment to equality, diversity and inclusion
• Aware of own limitations / competence and will seek help and support from others, and be honest about errors made and ways to rectify
• Patient-focussed, caring, empathetic and compassionate
• Enthusiasm and willingness to learn
• Able to work by themselves in an office / at home by themselves and able to work around others e.g. in open plan office
• Able to be assertive and speak up when disagree in a respectful way

Personal Qualities

Essential

• Team player and supportive of colleagues, demonstrating civility and respect to colleagues and patients at all times
• Passionate about research and innovation and improving patient care
• Professional attitude, diplomatic and calm under pressure
• Able to demonstrate a commitment to equality, diversity and inclusion
• Aware of own limitations / competence and will seek help and support from others, and be honest about errors made and ways to rectify
• Patient-focussed, caring, empathetic and compassionate
• Enthusiasm and willingness to learn
• Able to work by themselves in an office / at home by themselves and able to work around others e.g. in open plan office
• Able to be assertive and speak up when disagree in a respectful way

Person Specification
Qualifications

Essential

• English and Maths GCSE, or equivalent
• Level 3 qualification/s, e.g. A' levels, NVQ, etc

Desirable

• Computer Literacy Course, e.g. ECDL, or other experience or qualification
• ICH GCP (Good Clinical Practice)

Experience

Essential

• Experience working within healthcare
• Experience of working with the public or people form a range of backgrounds

Desirable

• Knowledge of healthcare research
• Experience working within the NHS

Skills/Knowledge

Essential

• Effective written and oral communication skills
• Computer literacy within a range of applications (including basic keyboard skills, MS Office)
• Understand the importance of confidentiality, dignity and respect in relation to both staff and patients
• Ability to accurately transcribe data from one source to another (e.g. written / electronic system onto paper / electronic report)
• Able to concentrate for long periods of time
• Meticulous attention to detail and quality
• Able to follow instructions, guidelines, policies and standards to provide a safe and effective service to others
• Able to work autonomously and organise themselves to manage own workload

Desirable

• Familiarity with medical or scientific terminology
• Venepuncture
• Laboratory skills

Personal Qualities

Essential

• Team player and supportive of colleagues, demonstrating civility and respect to colleagues and patients at all times
• Passionate about research and innovation and improving patient care
• Professional attitude, diplomatic and calm under pressure
• Able to demonstrate a commitment to equality, diversity and inclusion
• Aware of own limitations / competence and will seek help and support from others, and be honest about errors made and ways to rectify
• Patient-focussed, caring, empathetic and compassionate
• Enthusiasm and willingness to learn
• Able to work by themselves in an office / at home by themselves and able to work around others e.g. in open plan office
• Able to be assertive and speak up when disagree in a respectful way

Personal Qualities

Essential

• Team player and supportive of colleagues, demonstrating civility and respect to colleagues and patients at all times
• Passionate about research and innovation and improving patient care
• Professional attitude, diplomatic and calm under pressure
• Able to demonstrate a commitment to equality, diversity and inclusion
• Aware of own limitations / competence and will seek help and support from others, and be honest about errors made and ways to rectify
• Patient-focussed, caring, empathetic and compassionate
• Enthusiasm and willingness to learn
• Able to work by themselves in an office / at home by themselves and able to work around others e.g. in open plan office
• Able to be assertive and speak up when disagree in a respectful way

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.

Employer details

Employer name

Worcestershire Acute Hospitals NHS Trust
Address

Charles Hastings Way

Worcester

Worcestershire

WR5 1DD

Employer's website