Clinical Research Nurse

Job description

Job responsibilities

As a Research Nurse, you will provide specialist skills and knowledge to support the delivery of clinical research studies. You will work with clinical investigators ,sponsor companies and external vendors to manage trial protocols. You will be expected to deliver high quality research ensuring pateint safety and welfare. The nature of the work is unpredictable, and you will be expected to be flexible and responsive in order to manage various aspects of the job at short notice. You will be expected to participate fully in your own personal development.

Main duties and responsibilities

Research

Ensure that all research is delivered in accordance with ICH GCP guidelines http://ichgcp.net/2-the-principles- of-ich-gcp-2 and The UK Policy Framework for Health and Social Care Research http://www.hra.nhs.uk/resources/research-legislation-and-governance/research-governance-frameworks

Ensure familiarity with risk issues pertaining to confidentiality of participant and research related documentation (General Data Protection Regulation 2018 and Caldicott Review 2013)

Ensure compliance with all study protocols and study supporting documents

Responsible for managing multiple sites from set up to closure. To include identification and recruitment of patients in accordance with study protocols and to agreed targets and timelines

Responsibility for participant screening, eligibility, and provision of information to facilitate effective informed consent or assent

Responsible for recording, reporting and escalating adverse drug reactions and adverse events, according to study protocol and Clinical Trial Regulations

Responsible for the processing and shipment of biological samples

Collaborating with any investigations and subsequent management

Contribute to research governance processes including critical incident reporting in line with standard operating procedures (SOPs)

Ensure clear and accurate records and documentation to support and record all research activity using databases, software and electronic health care records as requiredWork collaboratively with data managers and clinical research monitors to ensure timely resolution of data queries

Investigator Site File maintenance

Participate in audits and inspections as required

Support and execute all activities in line with ISO standards where relevant (ISO 9001:2015)

Work in a variety of settings including hospital, community settings, possibly as a lone-worker, to meet the demands of studies

All relevant training completed in a timely manner

Development and utilisation of trackers and spreadsheet tools to support study delivery to timelines

Professional and Clinical

To work within professional guidelines and in a manner consistent with the NMC code

Ensure safeguarding principles are adhered to

Develop a full understanding of the Electronic Medical Records (EMR) systems

Ensure adherence to NWEH policies and Standard Operating Procedures (SOPs)

Promote research by effective collaboration and communication with departments both within NWEH and with external organisations

Appropriate escalation of any issues which may affect delivery of the study within specified timelines

Awareness of current trends and developments within global clinical research

Education

Participate in own personal development and review process and revalidation with the Nursing and Midwifery council (NMC). Act in a manner consistent with The Code NMC (2015) carrying out the role in accordance with locally agreed policies and procedures

Complete mandatory training, identify own learning needs and educational opportunities

Leadership

To provide mentorship and support for other and new staff members and assist in orientation/induction

Support NWEH in delivering objectives

Attend and contribute to clinical team meetings

Be actively involved in promoting NWEH clinical research

Benefits

Competitive Salary

27 days annual leave

Healthcare Cash Plan

Modern offices in Central Manchester

Positive and supportive environment

Access to training resources

Stakeholder Pension

Eyecare Vouchers

Generous Life Insurance

Electric Car Scheme

Person Specification

Qualifications

Essential

• NMC Registration with no limitations to practice
• Effective communication and interpersonal skills
• Experience of explaining complex concepts to patients in a clear and concise manner
• Evidence of continuous professional development
• Able to work autonomously and as a team player
• Attention to detail and high level of accuracy
• Demonstrable IT skills
• Flexible working
• Highly motivated with the ability to organise own work and meet deadlines
• Clean driving licence
• Willing to use own car (mileage recompensed following policy) and insure car for business use
• Knowledge
• Knowledge of regulations and governance in clinical research including EU directives and ICH GCP requirements

Desirable

• 1st level degree or studying towards
• Experience working in Primary Care
• Experience working in Clinical Research
• Presentation skills
• Venepuncture
• A good level of IT understanding will be an advantage

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.

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Employer details

Employer name

Northwest Ehealth

Address

North West E Health Ltd

5 Pencroft Way

Manchester

M156GZ

Employer's website

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