Clinical Research Practitioner

Job description

Job responsibilities

Please see attached Job Description for full details

The Middlewood Partnership is a GP Practice and Primary Care Network of 34,000 patients, established in April 2019. We operate from four sites across Bollington, Disley and Poynton.

We are always looking to invest in our teams and the organisation with a structured focus on great people. We are looking for a candidate who shares the Middlewood Values and Behaviours, and has the energy, skills and enthusiasm to contribute to our Research team.

The purpose of the role is to provide research delivery support for clinical trials being delivered by the practice.

The post holder will be expected to carry out study activity from patient recruitment through to study completion in a professional, friendly, competent manner, ensuring the welfare of the patients at all times and the completion and maintenance of accurate study specific records.

The post holder will be expected to work as part of a team alongside the Principal Investigator, study coordinator, sub-investigator and the rest of the delivery team.

To maintain and protect the patients interests at all times in line with the Research Governance Framework, Good Clinical Practice, all applicable regulatory requirements and in line with the individuals regulatory registered body.

To support in identifying future potential pipeline studies and liaise with the NIHR RDN in reporting research activity.

Performing EMR searches to complete feasibility assessments and to support pre-screening activity.

Using pre-set criteria to identify (and action accordingly) patients suitable for a specific clinical trial through patient record and document review.

To provide and communicate study information effectively to patients to allow them to reach an informed decision whether to participate in the study, ensuring the patient fully understands the nature of the study, that it is of voluntary entry and that the patient has the freedom to withdraw at any time without affecting clinical care.

To assist and support clinicians in ensuring the patients fully understand the study and their agreement to consent is voluntary.

To liaise with physicians to obtain informed consent or obtain informed consent in line with study specific protocols (SSP).

To perform study visits in line with study specific protocols.

To have a comprehensive understanding of all study protocols (including any protocol amendments).

To perform venepuncture as required by SSP.

To perform observations in line with SSP, including blood pressure, weight, anthropometric measurements, and demographic details.

To prepare blood and urine samples as outlined in SSP.

To assess patients blood and urine results to highlight any abnormal results to Investigator, for further action.

To provide verbal and written information and to offer counselling and support to patients for the duration of their involvement in a clinical trial.

To maintain accurate and up to date patient logs of patients screened/eligible/ineligible etc for a clinical trial.

To collect and accurately record data in case report forms during patient visits, in accordance with the requirements of the study protocol and in line with GCP and all applicable regulatory requirements.

To maintain accurate and comprehensive visit notes in the patients medical records.

To keep the patient informed of all results throughout the research process in line with GCP and all applicable regulatory requirements.

To order couriers for sample collection as outlined in SSP.

To dispense IMP in line with relevant SSP.

To undertake study visits as required in the protocol and liaise with Principal Investigator.

To report any serious adverse events to the Study Coordinator/Investigator immediately. Report any adverse/serious adverse events to the Study Sponsor within the time stated in the SSP.

To ensure time is available to Monitor/Sponsor Company visits.

To complete all data queries within a specified period of time. Ensure filing and any administrative duties are also up to date.

To attend team meetings, training days and Study Investigator Meetings as required.

To plan annual leave to accommodate projected activity within the team.

To cover duties of other team members when required.

To assist with internal and external audits, when required.

To identify gaps in knowledge and ensure steps are taken to rectify through the appraisal process and maintain own professional development.

Guaranteed Interview Scheme

Applicants with a disability, who meet the minimum criteria for the job they are applying for, will be guaranteed an interview. Suitable candidates must indicate in their application that they wish their application to be considered under the scheme (if applicable)

Person Specification

Qualifications

Essential

• Registered (or progressing towards) with a relevant professional regulatory body

Desirable

• Educated to degree level or equivalent

Experience

Essential

• Background of patient facing clinical experience

Desirable

• Previous experience of clinical research

Knowledge and Skills

Essential

• Project management skills
• Ability to work across multiple I.T. platforms

Qualities/Attributes

Essential

• An understanding and acceptance of and adherence to the need for strict confidentiality
• Ability to use own judgement, resourcefulness, common sense and initiative
• Ability to work without direct supervision and determine own workload priorities
• Ability to work autonomously and as part of a multi-professional workforce
• Articulate in both spoken and written word
• Able to work under pressure and in a changeable environment
• Car user and driver, flexibility and willingness to travel between Middlewood practice sites

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

The Middlewood Partnership

Address

Bollington Medical Centre

Wellington Road

Bollington

Macclesfield

Cheshire

SK10 5JH

Employer's website

https://middlewoodpartnership.co.uk/ (Opens in a new tab)