Detailed job description and main responsibilities

Clinical Research

• To take responsibility for a portfolio of clinical trials across a range of clinical specialty areas.
• To ensure that all research studies are conducted to ICH-GCP and EU standards.
• To assess and complete feasibility for both non-commercial and commercial studies.
•           Identify, assess and recruit suitable trial participants ensuring they and their carers are fully informed of all trial treatments and procedures; Assist in the identification of patients suitable for recruitment into trials using trial specific inclusion and exclusion criteria.
• To take informed consent from patients/volunteers or their legal representatives for enrolment onto clinical trials, where this has been agreed by the Principal Investigator.
• To act as the named nurse contact for patients/volunteers and provide ongoing advice and information with regards to their participation in clinical research, maintaining a supportive role throughout the studies.
• To coordinate investigations, treatments and procedures according to study protocols.
•           Provide advice to patients during face-to-face consultations and via the telephone, seeking further advice from the trial investigators and sponsors where appropriate.
• Word processing standard letters and other communications as appropriate.
• To accurately collate data on relevant research proformas within a pre-determined timeframe and respond to data queries; ensure that patients’ details are recorded on the appropriate electronic systems.
•         To maintain a record of all patient interventions for inspection of the study investigator and sponsor in accordance with GCP guidelines, Research Governance Framework and all other applicable regulatory requirements
• To liaise with representatives from pharmaceutical companies and prepare data for monitoring by these representatives.
• To report serious adverse events accurately and promptly to the relevant authorities.
• To accurately report and document side effects and ensure any modifications required as a consequence are carried out.
• To process, store and despatch biological samples according to research protocols and trust policies and guidelines.
• To educate patients and their carers with regards to medications particularly when medications require self-administration at home.
• To provide cover, where appropriate, for colleagues during staff absences.
•            To deputise for other Research Nurses to assist with the completion of patient visits and case report forms when delegated.
• It may be necessary to perform venepuncture/ blood pressure when required for research purposes and if so, the necessary training and competency assessment will be conducted. It may be also necessary to collect other biological samples.

Clinical Service and Professional Responsibilities

• To work as part of the multidisciplinary team and contribute to the ongoing development of the department.
• To be responsible for maintaining strong relationships and positive communication channels with other key personnel.
• To take an active role in regional research networks.
• Work within the NMC Code of Conduct.
• To observe the confidentiality of patient information at all times, in accordance with the General Data Protection Regulations (GDPR).
• To be conversant with cardiac arrest, major incident and fire procedures as they relate to clinics within the Directorate.
• To be conversant with and adhere to all clinical protocols and local department protocols and SOPs.

Personal Education, Training and Development

• To keep up to date with Departmental, Trust, NHS and EU developments for the implementation of clinical research.
• To keep up to date with current and potential research and information relevant to the care of patients in the clinical area.
• To attend courses, meetings and conferences as deemed relevant and appropriate.
• To be responsible for developing and sustaining own knowledge, clinical skills, professional awareness and maintaining revalidation portfolio.

Staff Management and Development

• To act as a resource, mentor and role model.
• To facilitate and maintain effective communication within the Research Team.
• To undertake staff performance development reviews as required.

This Job Description is subject to change in consultation with the postholder and Line Manager as service needs determine.

GENERAL RESPONSIBILITIES

Safeguarding Children & Adults

Understand and work within policies and local procedures relating to Safeguarding Children and the Protection of Vulnerable Adults.  

Health & Safety

You are responsible, in respect to your area of work, for ensuring so far as is reasonably practicable and in accordance with Trust policies a healthy and safe environment for relevant clients and patients, employees and trainees, volunteers, visitors and members of the public on our premises, contractors and other people using the Trust’s services, and for the provision of the information, training and supervision that is required to achieve this responsibility.  This requires you to:

·   comply with any health and safety regulations or trust policies or procedures that affect your area of work.

· raise matters of non-compliance with your manager or other advisers to reach appropriate solutions.

· are familiar with the Trust’s Health and Safety Policy and your department’s Health and Safety Control Book or Manual.

Manual Handling

Manoeuvre light goods and equipment in accordance with manual handling regulations and good practice

Right Care Values

Responsible for embodying, and encouraging in others, the Right Care Values, using the behaviours identified for each value as a basis for decision making and your behaviour. Also responsible for embedding the Right Care Values in all support to staff and line management processes, recruitment, performance management, sickness management and PDRs.

Equal Opportunities

Carry out your duties in line with Trust Equality policies and procedures, including relevant legislation, to deliver and promote equity of access to healthcare and equality of opportunity at work at all times.

Infection Prevention and Control

Be responsible, in respect to your area of work, for ensuring so far as reasonably practicable and in accordance with Trust policies, that all staff are aware of their individual responsibilities in regard to infection prevention and control, and for the provision of the information, training and supervision that is required to achieve this responsibility. This requires you to:

·    Maintain a safe infection prevention and control environment for yourself and others

·    Be familiar with and comply with Trust guidelines, policies and procedures relating to Infection prevention and control

·   Raise matters of non-compliance with your manager or other advisers to reach appropriate solutions

· Ensure that infection prevention and control guidelines, policies and procedures are distributed to relevant staff

·  Ensure procedures specific to your specialty are in place, in collaboration with the Infection Control Team

·    Ensure that infection prevention and control forms part of staff appraisal

Mandatory Training

Be aware of and undertake mandatory and other training requirements necessary for the successful and safe performance of your job, including relevant updates.

Information Governance

Maintain and process all information concerning patients, staff, contractors or the business of the Trust to which the post holder has access, without divulging such information to any third party or make use of information gained in the course of employment, except where this is clearly within the remit of the post holder and the other party’s responsibility.

The Trust recognises the importance of reliable information. The quality of this data is crucial in that it should give a complete, accurate and timely representation of events to support patient care, clinical governance, monitoring performance, management and service agreements for healthcare planning and accountability.  All information entered onto any record whether manual or electronic or any other media (film, tape etc.) should be accurate, timely, complete, valid, defined, appropriately sought, appropriately recorded and should be stored securely and confidentially.  Further information on the Trust’s “Health Records Policy” can be obtained from the Trust’s Intranet site.

Any other duties necessary for the successful performance of the role.

Restriction on Smoking

The Trust is “Smokefree”. You may not smoke in Trust owned buildings or grounds except in the designated smoking zones.

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The Trust is committed to supporting staff in balancing their work and home lives and encourages staff to discuss their individual needs with their department in order to arrive at mutually satisfactory working arrangements.

This job description is a reflection of the current position and may change in emphasis or detail in light of service developments.  It will be reviewed annually as part of the appraisal/performance development review process.