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Job Details
Pay: £37,338 - £44,962 a year
Job Type: Permanent
Location: Manchester M20 4BX
Full Job Description
Job Purpose: The post holder will be responsible for the co-ordination of a defined group of clinical trials from set up to archiving and meeting agreed patient recruitment targets. The post holder will also ensure that all research undertaken within the department safeguards the well-being of the patients and is conducted within the requirements of a multi-regulated clinical research environment.
Duties and Responsibilities
1. Clinical Research Co-ordination
* Work autonomously in all areas of practice relating to clinical research.
* Understand and deliver care in accordance with regulatory approved clinical research protocols.
* Understand the process for obtaining NHS permissions (R&D approval) for conducting clinical trials at site.
* As project lead, ensure permissions are in place prior to any patient recruitment.
* Participate in clinical trial feasibilities and risk assessments of clinical trial protocols.
* Ensure all clinical trial activities are recorded in appropriate systems in a timely manner.
* Identify and implement strategies for recruiting patients to clinical trials ensuring that targets for patient recruitment are delivered.
* Delegate and oversee research related activities to research team members (clinical and administrative) and ensure compliance with SOPs and ICH/GCP.
* Arrange and facilitate clinical trial related meetings.
* Involvement in appropriate financial remunerations for clinical trial activity.
1. Clinical Service and Professional Responsibilities
* Assimilate highly complex information relating to clinical trials and communicate to patients at a level appropriate to their understanding.
* Ensure highly sensitive information is communicated to patients, relatives, and carers regarding prognosis.
* Contribute to the development, implementation, and review of specialist care pathways in conjunction with appropriate personnel.
* Demonstrate awareness of divisional and trust strategic objectives including performance indicators and metrics.
* Act as a primary contact point for the clinical trial patients and act as adviser to other health care professionals.
* Maintain and develop professional knowledge and practice by attending mandatory and specialist training in accordance with local policy.
* Oversee the safe administration of all licensed and unlicensed medicinal products within the context of a clinical trial.
* Contribute to development of specialist Standard Operating Procedures and guidelines.
* Participate in monitoring and audit activities within the research team.
2. Personal Education, Training and Development
* Maintain professional development whilst evaluating own specialist knowledge and practice through a process of appraisal and personal development planning.
* Promote the role of the clinical research nurse as an integral part of the healthcare system.
* Participate in trust-wide education programmes and study days.
3. Staff Management and Development
* Support the Senior Clinical Research Nurse in the induction and continued supervision of junior members of staff, ensuring compliance with regulatory compliance and legislation.
* Assist in the provision of specialist education and training in relation to clinical trials to all key stakeholders.
All personnel involved in clinical research have a responsibility to ensure that clinical trials are conducted in accordance with the EU Directive and ICH/GCP.
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