Clinical Trials Assistant

Job description

Job responsibilities

Key Working Relationships

Internal:

Departmental colleagues

Lead Research Nurse

Head of Research Operations

Research Management Team

Research Delivery Teams

Clinical Teams

Support Departments

External

Patients and their relatives/carers/significant others

Research Sponsor Organisations

Clinical Trials Units / Universities

Pharmaceutical companies / Contract Research Organisations

NIHR Research Delivery Network

Herefordshire and Worcestershire Research Consortium

Partner Organisations

Other External Research Teams

Risk Assessment:

Manual handling activities

Exposure to bodily fluids and exposure to high noise levels

It may also involve exposure to challenging behaviour

Works with display screen equipment for prolonged periods

Job Purpose:

We are committed to supporting research that is relevant and accessible to our patients. Through clinical research we can assess the efficacy of new medication, diagnostics, and treatment regimes. This helps to build the evidence for new approaches to improve patient care

The Clinical Trials Assistant will support the Research Delivery Team in the identification, recruitment and management of patients participating in research studies. The post-holder will help with data-collection, undertake specified clinical and laboratory tasks, and provide administrative support for research studies.

The department is involved in a range of clinical studies including life changing oncology and haematology trials, internationally recognised midwifery, renal and surgical studies, and many more. You will have the opportunity to get involved with a range of these, having direct contact with patients, carers and staff.

Key Duties

Clinical

Screen trust systems to identify patients who may be eligible for research studies

Receive consent from patients into research studies, under direction, and with appropriate training, in accordance with GCP

Randomise patients into different trial arms

Organise patient appointments and book research-specific investigations and procedures

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

Report all findings from clinical procedures to the research delivery team, and accurately document as advised by the team in appropriate patient records, research files, logs, CRFs and databases

Provide ongoing assessment of participants clinical condition liaising with relevant clinicians as appropriate, e.g. if patient condition alters

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

Collect prescriptions and liaise with pharmacy to coordinate trial medication

Explain and distribute research participant questionnaires, diaries and the NIHR Participants in Research Experience Survey

Communicate sensitive information to patients

Provide ongoing information to patients regarding their participation in research studies in writing, by telephone, and by e-mail

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

Contribute to patient and public involvement and engagement activities

Administrative

Work with the multi-disciplinary team to conduct feasibility assessments for new research studies

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

closure, and archiving

Work with the Research and Innovation team to ensure compliance with regulatory requirements

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

Create digital patient tracking systems, e.g. using Excel

Assist in the entry of accurate and timely documentation of data into participant Case Report Forms

Assist with the resolution of raised data queries

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

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

Update research management databases, including EDGE

Ensure that patient identifiable records for research studies are stored according to Information

Governance policies

Assist with maintenance / ordering of research and office supplies

Coordinate and disseminate amendments including preparation of any updated paperwork

Liase with trial units and commercial sponsors to coordinate trial activities

Maintain financial information and patient records to allow payments to be made

Handle petty cash and travel expense claims for patients

Attend local and national meetings as required

Record relevant meeting notes, minutes and actions, and circulate these appropriately

General administrative duties including answering the telephone, answering queries, managing the research email inbox

Maintain awareness of key performance indicators and next steps to achieve them

Provide cover to other members of team as relevant to role

Liaise with other departments for equipment maintenance, calibration and repair

Training and Education

As part of this role you will receive the following training:

Trust Induction

CREATE training (Clinical Research Explained)

Improving Healthcare through Clinical Research MOOC

Clinical skills training, including phlebotomy

Good Clinical Practice training

Data Quality in Research training

Informed Consent training competency

Site File Management training

Case Report Form (CRF) completion training

EDGE training

Amendments training

Archiving training

iPROC system training

Regular performance development reviews

General Duties

Travelling between sites is an essential part of this role

Any other duties as may be agreed in the course of undertaking this role, 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

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

https://www.worcsacute.nhs.uk/ (Opens in a new tab)