Clinical Trials Support Officer

Job description

Job responsibilities

Role summary

You will join a fantastic team of staff and volunteers, working together on this important national research study which is already improving care of people with Multiple Sclerosis and Motor Neurone Disease. The team consists of a Band 7 Research Coordinator; two Band 4 Clinical Trials Support Officers (including this post under recruitment and described herewith); Band 2 data entry post, statisticians; PhD student in health economics; bank staff; volunteers, and a number of Principal Investigators (PIs).

The TONiC group began pilot recruitment in 2012 and by 2020 had over 6000 people with MS, and 1000 people with MND recruited. Already more than 40 conference presentations have been given on this innovative study and many papers produced. As the largest clinician-verified quality of life study in the world, TONiC provides excellent multicentre study experience, and previous members of the TONiC team have moved on for career developing posts in London, NIHR roles or PhD study.

The successful applicant will possess methodical and efficient research skills alongside very good people skills for working in a friendly, cohesive team and interacting regularly with patient participants. The post combines research activity (including but not restricted to co-ordinating the dispatch and receipt of questionnaire packs, data entry and keeping sites and participants informed), alongside contact by a mix of phone, email and in person with participants. Both the Band 4 CTSOs will be sharing the regular patient contact for an observational study in TONiC phase 7. The post holder will arrange research clinic appointments; meet patient participants face to face through being present in the research clinics; their role in clinic is to be a friendly face co-ordinating provision and collection of some assessments and questionnaires completed by the patient on the day of their visit. These assessments include checking the participants height and weight; vision testing using letter chart; Single digit modality test (SDMT) testing, by providing set instructions and test sheet to a participant, then stopping them completing their test after 90 seconds, and scoring number of correct answers; 9 hole peg test (9HPT), where participant puts pegs in holes in board while timed by tester; timed walk for 25 feet and also shorter distance with u-turns. (We do not expect the post holder to have experience of doing these tests before they join the team.) The post holder will need to be able to organise their own workload for staying in touch with these same participants by phone or email. The purpose of staying in touch is to encourage participants to regularly use an app (Floodlight-MS) on their smartphone, so at the start of the study the post holder must be able to help participants who do not know how to download or use an app from the Appstore. Therefore in addition to having reliable organisational skills and attention to detail, the post holder must have excellent communication skills and commitment to working alongside patients and the team to deliver this exciting research.

This post is a fantastic opportunity for career development for a researcher who wants to deliver high quality research and have direct patient contact. It includes experience with large multicentre trial delivery, Patient Reported Outcome Measures, some of the clinical assessments which are nowadays done by non-clinically qualified research staff, digital health apps and longitudinal patient adherence all of these are important and growing research areas so having experience in these transferable skills is highly advantageous.

Key responsibilities

Assisting the researcher and study team in the planning and running of the research project, he/she is responsible for:

Regular phone, email and in-clinic contact with participants of TONiC phase 7.

Arranging research clinic appointments

Assessments include checking the participants height and weight; vision testing using letter chart; Single digit modality test (SDMT) testing, by providing set instructions and test sheet to a participant, then stopping them completing their test after 90 seconds, and scoring number of correct answers; 9 hole peg test (9HPT), where participant puts pegs in holes in board while timed by tester; timed walk for 25 feet and also shorter distance with u-turns.

Be able to help participants who do not know how to download or use an app from the Appstore.

Planning/organising and posting study packs according to protocol timelines.

Liaising with study collaborators, participants and the study team, including by telephone and email.

Monitoring and maintaining the supply of study documents.

Monitoring and inputting study databases and spreadsheets.

Taking responsibility for carrying out regular telephone and email follow up with any TONiC participants, according to study protocols.

Sending out study documents to interested participants.

Maintaining effective filing systems including questionnaires and administrative files.

Formatting documents to group requirements in preparation for printing.

Assisting in the maintenance and organisation of the Investigator Site Files.

Assisting on study as required by the researchers/study team.

Preparing and distributing recruitment updates to those involved with the study.

Organising meeting rooms, refreshments & technical equipment.

Meeting administration and support, including taking minutes.

Receiving telephone enquiries from participants, volunteers and professionals.

Communicating effectively, dealing with problems and escalating to senior colleagues as necessary.

Working co-operatively on the day to day activities of the office and administration tasks.

Ensuring that work is prioritised according to the needs of the project.

Assisting with general group administration tasks, which are appropriate to the grade.

Identifying potential problem areas in the study and providing pro-active trouble shooting to help ensure the study is delivered successfully.

Producing monthly newsletter and emailing to study collaborators.

Producing quarterly newsletter for patients and emailing out.

Social media regarding studies, such as blogs, Twitter, Facebook etc.

Recruiting and consenting participants to the study and collecting required data.

Training & Development

Attendance at mandatory study days.

Continual update of personal development programme / attending courses accordingly.

Reviewing updates of any existing administrative and secretarial procedures.

Ensuring staff are aware of their responsibilities in respect of compliance with trust policies.

Provide induction, training and support to staff, including volunteers.

Each member of staff is responsible for attending mandatory study days eg health & safety training. Isoft training is also needed to update patient details, appointments, tracking case notes and general enquiries. There are also optional training courses, which are open to all staff eg ECDL.

Person Specification

Qualifications

Essential

• Educated to NVQ 3 level / A level standard or equivalent ECDL.
• Or experience in the relevant field.

Desirable

• Degree.

Experience

Essential

• Have excellent working knowledge of Word, Excel, and PowerPoint.
• Office management and clerical skills.
• An understanding of clinical research procedures and experience of clinical research in the UK.
• Previous experience of working with multidisciplinary team in a healthcare or research environment.
• Knowledge of requirements and practicalities of Good Clinical Practice and Research Governance, together with the ability to disseminate this knowledge and information.
• Excellent communication and inter-personal skills, including good telephone manner.
• Ability to communicate effectively with academic and clinical research staff at all levels across the organisation and external research partners to develop effective working relationships to enable the effective running of the project.
• Ability to work autonomously using own initiative, and as a member of a team.
• Ability to prioritise, organise and plan own workload.
• Ability to deal with the public and colleagues in a pleasant and polite manner at all times.

Desirable

• Experience of handling medical data, preferably in an NHS or pharmaceutical company environment.
• Experience of using databases, such as Access or FileMaker.
• Familiarity with the issues surrounding clinical data, particularly confidentiality.
• ICH GCP and Research Governance trained.
• Knowledge of the REC and R&D application processes.
• Ability to perform venepuncture.

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 UK Visas and Immigration website (Opens in a new tab).

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. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Employer details

Employer name

The Walton Centre NHS Foundation Trust

Address

The Walton Centre

Lower Lane

Liverpool

L9 7LJ

Employer's website

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