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Detailed job description and main responsibilities

Responsible for specific study-related medical decisions (if within expertise, or in consultation with PIs).

Medical cover for studies, initiate definitive strategies to anticipate and expertly manage medical safety issues, including emergencies.

Responsible for overseeing the management and administration of study drugs for designated studies to healthy volunteers/patients according to local standard operating procedures and research protocols.

Assessing and reporting adverse events in accordance with the protocol and regulatory requirements.

Assessing participant capacity and receive informed, voluntary consent.

Write prescriptions.

Venepuncture for local blood tests. Review blood test results and action, liaise if necessary, with participant, clinical teams and GP.

Clinical review of results of all physical and psychometric assessments.

Understand and discuss the patient information sheet (PIS) with potential participants in their home or clinic and talk through the nature of the study. Be able to answer any questions related to the medication (dose, timings, side effects, etc.) and trial procedures.

Ensure completion of study related training (e.g. data entry training, GCP training and protocol specific training) prior to commencing activity on the study.

Ensure timely and accurate entry of data and relevant information into appropriate database systems.

Ensure that study documentation is maintained appropriately and that an audit trail exists. Contribute to the recording and storing of information, ensuring it is securely held, accurate, complete and legible and can be promptly retrieved when required.

Assist with the maintenance of patient care records, uploading relevant clinical information onto RiO where required.

Support the clinical research delivery team with preparation for audits and external inspections.

General research-related communication in accordance with General Data Protection Regulations.

Assist clinical trial monitors in site visits, with the accurate monitoring of study data.

Contribute to the planning, development, implementation and review of services, making suggestions for change and improvement, including taking part in evaluations of service quality and allocation of resources.

Contribute to the effective and efficient use of resources by ensuring that supplies are available, alerting senior staff when supplies are short, and by making suggestions to reduce waste.

Ensure a healthy, safe and secure working environment, ensuring compliance with legal and regulatory requirements, maintaining accurate documentation and reporting any concerns.

To comply with the organisational and local policies and procedures and to be involved in the reviewing and updating as appropriate.

Participate in regular supervision, engage in reflective practice and be committed to continued development. Develop a clear understanding of the service and role. Provide cover for colleagues in other areas where necessary.

Attend relevant education and training days/programmes, as necessary.

Support with induction for new employees, under the direction of the R&D Manager.

Training and development of medical and nursing staff, including planning and provision of seminars and lectures.

Undertake and participate in appropriate audit, quality assurance programmes, service evaluations and research as directed.

Engage with clinical colleagues to advance research ideas, collect data, conduct reviews of literature, and write reports and/or funding applications.

Please see job description for further details.