JOB DESCRIPTION

Job Details:

Job Title: Clinical Trials Assistant

Band: 4

Location: Norfolk and Norwich University Hospital

Department: Neurolgy Research

Managerially Accountable to: Senior Research Nurse

Professionally Accountable to: Research Matron

Job Purpose:

The post-holder will work alongside the Neurology research trials team for the
delivery of all aspects of Neurology clinical trials within the NNUH. This is in
accordance with ICH-Good Clinical Practice (GCP), EU clinical trial regulations,
standard operating procedures (SOP’s) and Trust policies. The post-holder will be
responsible for daily trials activities according to the specific requirements within their
competencies and experience.

To support the delivery of a high quality, safe and compassionate healthcare service,
all staff are expected to act as a role model to others in all aspects of their work and
consistently demonstrate NNUH’s ‘PRIDE’ values of People focused, Respect,
Dedication, Integrity and Excellence.

Overview of Essential Responsibilities:

1. Provide administrative support to the research team for all research trials on the
Neurology team portfolio from trial feasibility to archiving

2. Assist with logistical issues for the set-up and running of the study/trial to
ensure the well-being and safety of patients, participants and staff, in
accordance with research regulation

3. Provide research participants with the appropriate information regarding their

participation in a research trial

4. Provide a high standard of care for participants during the research study,
maintaining lines of communication with research trials team and wider support
departments

5. Act as a resource to participants, their families and staff from within the clinical
area, providing information and support

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6. Take and process clinical trial samples, following appropriate training, (e.g.
venepuncture, centrifuge training) as per protocol and specific laboratory
requirements

7. Co-ordinate tissue sample collection and dispatch to relevant department or

trial centres as appropriate

8. Undertake research-associated laboratory work safely, as required, including

the competent handling of dry ice for frozen sample shipment

9. Maintain basic clinical skills as appropriate (following training) e.g. vital sign
assessment, patient compliance, and ECGs

Research:

1. Participate in the Co-ordination and management of research studies within

expected timelines

2. Understand the requirements of the study protocol and adhere to them

3. In conjunction with the research nurse/CTP, identify suitable participants

eligible for the study/clinical trial; identify, screen and recruit research
participants using detailed knowledge of the protocols for the designated site
specific groups

4. Assist with developing and maintaining trial specific working folders to facilitate
effective running of trials

5. Complete documentation with meticulous attention to detail and complete

accurate records of patient care, maintaining source data and Case Report
Forms (CRF)

6. Reporting of Serious Adverse Events (SAEs) and Suspected Unexpected

Serious Adverse Reactions (SUSARs) immediately using the appropriate
procedures

7. Provide ongoing support, advice and information to patients/participants with

regard to their participation in research trials

8. Receive informed consent where appropriate; maintain the continuous informed

consent of participants to ensure that the procedures and treatments agreed
within the trial protocol are fulfilled

9. Co-ordinate a case load of participants within the allocated trials, e.g.

organising trial-specific investigations, study treatments, appointments etc. as
necessary

10. Collect accurate local data and deliver to clinical trial centres in a timely manner
adhering at all times to the terms of the Data Protection Act and Information
Governance regulations

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11. Prepare for and facilitate audit by the Trust Research Department and/or
Regulatory Authorities for GCP compliance

12. Assist the research nurse/CTP to ensure that trial updates and amendments
are reported in a timely fashion

13. Attend relevant local, regional and national meetings related to specific trials

14. Work closely with the research nurses/CTPs with the resolution of data queries;
and with the planning, running and closedown of studies

15. Be responsible for study closure and archival preparation

Communication:

1. Liaise with the local Research Teams and Research and Development
providing necessary research related information as required

2. Liaise with members of the departments who are involved in the conduct of
specific trial procedures, such as pharmacy

3. Liaise with clinical trial centres and units as necessary and with relevant
departments in order to ensure smooth running of clinical trials for patients

4. Communicate effectively with research participants on all aspects of clinical

research

5. Attend local team meetings and any national/International meetings as

appropriate

Education:

1. Develop and sustain own knowledge, clinical skills and professional awareness
in clinical research

2. Act as a knowledge resource of individual research projects and the research

submission pathway

3. Advise staff and researchers on data collection, data entry and safe data
storage

4. Develop, update and maintain theoretical and clinical skills and knowledge of
the relevant clinical speciality/disease process as appropriate

5. Mentoring of students during their research placements in the department

alongside the research nurses/CTPs

Line Management/Financial Management Responsibilities:

1. Manage and organise own workload within study/clinical trial requirements

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2. Undertake the practical organisation and management of trial participants and
the administration of information

3. Responsible for the facilitation of research trial monitoring visits

4. Adhere at all times to Trust policies and procedures

Functional Requirements
Direct face to face patient Yes Blood/body fluid exposure Yes
contact
Exposure prone No Prevention and No
procedures (EPP) management of aggression
Manual handling Yes Crouching/stooping or Yes
kneeling
Night working/shift work No Frequent hand Yes
washing/wearing gloves
VDU user Yes Chemical sensitisers No
Driving patients No Noise No
Other (please state) No

Job Specification:
Means of Assessment
Essential/ Application Form/
Desirable Interview/Test
Qualifications/training and
professional development

Educated to Diploma level or have E A/I

significant administration experience

NVQ level 3 healthcare or equivalent D A/I

education

ICH GCP training D ICH GCP training

Certificate/Diploma in Clinical research D Certificate/Diploma in

Clinical research
Experience

Working with patients in an NHS E A/I

environment

Experience of working collaboratively E A/I

Experience of running concurrent D A/I

research studies with minimal
supervision

Good knowledge base of the regulatory E A/I

issues relating to the conduct of
research in humans
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Skills, abilities and knowledge

Excellent interpersonal and E A/I

communication skills

Good organisational, time & project E A/I

management skills: and able to plan,
prioritise & co-ordinate work under
pressure

Numerate with good IT skills; competent E A/I

in standard PC packages (Windows,
Microsoft Excel, Microsoft Access)

Proven administrative skills with D A/I

attention to detail

Able to or willingness to undertake E A/I

training to perform venepuncture as well
as basic laboratory skills including the
preparation of blood, urine, other bodily
fluids and tissue sampling of research
participants
Attitude, aptitude

Effective role model, demonstrating E AF/I

NNUH’s PRIDE values of People
focussed, Respect, Integrity, Dedication
and Excellence

Reasonable adjustments can be considered to support disabled candidates in

respect of the requirements of this role.

For information regarding general terms and conditions of employment please ask
your line manager or Human Resources.

This job description indicates currently the main responsibilities of the post. It is not
a complete list and may be amended and developed as necessary in consultation
with the manager and post holder. We would aim to reach agreement on any
changes, but if agreement is not possible, the Trust reserves the right to make
changes to this job description.

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