Clinical Trials Assistant

Job description

Job responsibilities

To disseminate information to consultants regarding new trials identified on the on the National Research portal to enable optimal patient recruitment.

Assist in the preparation of documentation when submitting trial protocols and paperwork to various committees and regulatory agencies for review and approval (ethics and Research and Development etc).

Assist in the set-up of trials on site i.e. liaise with trial centre and other relevant staff to organise trial set-up visit.

Request patient notes for screening purposes.

Identify patients suitable for entry into clinical trials by screening notes and attending Multi-Disciplinary Team meetings and clinics.

Processing blood samples in accordance with specific study instructions/packaging of samples in line with biologic sample preparation guidelines.

Consenting patients into non-clinical questionnaire only.

Liaise with clinical teams to organise and ensure that trial specific investigations are undertaken as and when required.

Liaise with Research nurse/radiographers/P.Is to record, organise and ensure the timely administration of treatment and any necessary follow up investigations and visits.

Assist in reviewing and recording treatments, adverse events, toxicities and response to treatment. Organise the collection, storage and shipment of protocol specific samples. Explain, dispense and collect patient quality of life questionnaires and diaries. Liaise with designated Pharmacist to co-ordinate the availability and dispensing of trial drugs if required on instruction from RGN/P.I/ Radiographer.

In discussion with research nurse report adverse and serious adverse events to the relevant personnel and act as required.

In conjunction with senior research nurses maintain contact with and provide on-going information and support to the patient in a sensitive and professional manner. Refer to other specialists as required in order to provide optimal patient care.

Within a Clinical Trials Assistant capacity you would be expected to demonstrate an understanding of the implementation of Good Clinical Practice (GCP) whilst adhering to study protocols and SOPs ensuring a safe environment for research participants. Liaise with trial centres and relevant departments in order to promote a good working environment and ensure the smooth running of clinical trials for patients.

Work at all times according to regulations described in local Standard Operating Procedures, Good Clinical Research Practice and European Directive.

Maintain adequate patient records and accurately document data collected in case report forms and nursing/medical notes.

Forward trial data in a timely manner to the trial co-ordinating centre and liaise with their personnel as necessary.

Ensure that clinical trial databases and logs are maintained.

Support mandatory research performance reporting to the NIHR. Collecting information from Trust project management systems and research teams in order to complete reporting templates. Submitting the above information, as stipulated by the NIHR and within strict timescales, under the direction of the R&D Directorate Manager.

Submission of the research performance information for publication on Trustnet, as per NIHR requirements.

Undertake duties as EDGE administrator for the R&D department. Responsible for checking data quality and responding to data queries, liaising with clinical and non-clinical colleagues and study sponsors to ensure complete and accurate study records are maintained on EDGE.

Support the training of staff in the use of EDGE, including the roll-out of updates to the EDGE project management system.

Confirm research recruitment activity for RWT sponsored studies in CPMS, checking with research delivery staff the number of screened/recruited/declined patients each month.

Confirm research recruitment activity with identified personnel at other sites undertaking RWT sponsored studies, ensuring information is accurate and up to date on CPMS.

Ensure the confidentiality of verbal, written and computerised information.

Will be required to complete necessary notes/research notes in preparation for patient visits.

Where appropriate assist research nurse in facilitation of research clinics.

Plan, prepare and participate in monitoring visits and respond to trial data queries.

Provide information to allow for invoice to be raised for payments where appropriate.

Attend local research meetings, induction and training programmes and any other relevant education and training days/programmes as appropriate.

To assist in demonstrating the value of research and innovation activity as part of the R&D and CRN marketing initiatives.

Provide support to other colleagues as required.

Person Specification

Qualifications

Essential

• Educated to a minimum of diploma standard or equivalent

Experience

Essential

• Proficient in Microsoft Office Suite, Excel, Access and PowerPoint
• Effective organisational skills

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 Royal Wolverhampton NHS Trust

Address

New cross Hospital

Wolverhampton

WV10 0QP

Employer's website

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