Clinical Research Practitioner

Job description

Job responsibilities

Job Summary:

To assess, plan and monitor care for patients as part of a clinical research team.

To act as an advocate for staff, participants and their relatives at all times. Keep abreast of innovations and developments in research governance, ethics and other regulatory and legal guidelines governing clinical research.

To support research across clinical specialities including diabetes, neurological, cardiovascular, respiratory, vaccines, mental health, and community-based care.

To help identify patients eligible for research projects, and recruit patients into clinical trials or studies.

To support the practice to ensure compliance with its statutory and regulatory obligations, such as but not limited to the Care Quality Commission and Data Protection Act 2018(GDPR)

Principal Activities Clinical Research

Assist in maintaining electronic databases and paper records, to ensure that patients schedules to have follow-up visits are not overlooked and have fulfilled all study assessments according to the protocol.

Assist in ensuring all documentation is filed in a timely manner and ready for inspection.

Assist with inspections as required.

Arrange couriers/post for clinical research samples.

Support the research team with general tasks, as required.

Possess IT skills Word, PowerPoint and familiar with email correspondence.

To directly communicate with patients on matters relating to their ongoing and highly complex health needs giving due consideration to the likelihood that there will be emotive issues which will require developed skills of tact, diplomacy, and empathy.

To ensure that patients have detailed assessments made of their healthcare needs and that individual programmes of care are planned, implemented, and regularly reviewed.

Facilitate patient referrals to appropriate clinical services.

To maintain and promote the safeguarding of all patients and their families/carers.

Respond to medical emergencies.

Ensure that the principles of Infection Control are always adhered to.

Provide information and support for patients involved in research projects.

Responsible for ensuring patients treatments, assessment, follow-ups, and data collection is co-ordinated and processed according to the appropriate research protocols. This will include close liaison with research teams, appropriate Research & Development Departments and with Clinical Nurse Specialists.

To support study set up including assisting with preparation of documents and authorisations.

To actively promote research amongst clinicians, service users, carers, and the wider NHS.

Taking responsibility for the management, co-ordination, and facilitation of concurrent research studies.

To provide clinical support and expertise on NIHR portfolio research projects.

Principal Activities Education and Development

To keep abreast of advances in clinical practice and identify personal training and development needs.

Support junior colleagues in their development by encouragement, informal teaching and coaching.

To attend meetings as directed by the Nurse manager or Trials lead, member of the senior management team and/or partners.

To attend mandatory training identified through the appraisal system.

Attend investigation meetings and site initiation visits to ensure an in-depth knowledge of all study protocols.

Maintain own training records.

Principal Activities Professional

Contribute and work within the broad framework of the clinical governance agenda.

Ensure that communication is effective between all stakeholders giving adequate attention to the complex and sensitive nature of such information. Make all reasonable attempts to overcome any barriers to understanding that may occur, giving due consideration to ethnicity, language, educational ability, barriers caused by illness/distress etc. which may adversely affect communication.

To work in a flexible manner to meet the needs of the service and as directed by senior staff and GPs.

Participate in the review of significant and near miss events applying a structured approach.

Principal Activities Administrative

Follow practice, ICB, ICH, NHS England and sponsor company policies, procedures, and guidelines.

Complete reports and forms required by the practice, ICB and NHS England

Participate in staff surveys and contribute to research-based practice.

Ensure all equipment and drugs with expiry dates are in date.

Research

Ensure that any data collection is conducted according to specific research protocols (in liaison with the research teams) and adheres to the Data Protection Act 2018 and according to Good Clinical Practice guidelines.

Adherence to and interpretation of research study protocols and standard operating procedures including compliance with local, national, and where appropriate, international research regulations.

To assist participants with the completion of questionnaires as necessary.

To take relevant patient samples for clinical trials, such as blood samples, package and dispatch as per defined protocols, where appropriate.

Maintain accurate patient trial documentation, complete Case Record Forms, including the use of electronic data capture systems and ensure relevant information is recorded in patients medical notes.

Coordinate treatment, assessment, and follow-up as necessary in accordance with Research protocol

Person Specification

Qualifications

Essential

• Minimum NVQ 3 plus additional experience
• or
• NVQ 4

Desirable

• Degree in scientific/healthcare discipline

Knowledge, Skills and Abilities and Other

Essential

• Knowledge/understanding of healthcare environments
• Excellent communication skills
• Awareness and respect for confidentiality
• Ability to communicate sensitive, confidential information requiring empathy, persuasion, and reassurance.
• Ability to work in a changing environment
• Able to develop networks and learn from others
• Ability to self-reflect
• Demonstrable IT skills including email and MS Office programs
• Proactive and able to work on own initiative
• Ability to organise and prioritise own workload
• Team player
• Ability to remain calm and professional under pressure
• Ability to delegate, where appropriate

Desirable

• Knowledge of ICH Good Clinical Practice regulations relating to clinical research.
• Medical knowledge/terminology specific to the speciality
• Knowledge of clinical governance.
• Knowledge of information governance
• Knowledge of electronic patient record systems eg. SystmOne
• Clinical skills including venepuncture
• Ability to troubleshoot effectively.

Experience

Essential

• Experience of working in a clinical or patient facing environment.
• Proven experience of working to deadlines.
• Proven experience of dealing with a busy workload.

Desirable

• Data management experience.
• Experience of working in a research environment.

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

Rowden Medical Partnership

Address

Rowden Hill

Chippenham

Wiltshire

SN15 2SB

Employer's website

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