Clinical Trials Practitioner

Background and Context

Specific Duties and Responsibilities

• Assist with a variety of clinical research projects and clinical trials, particularly in diabetes and endocrinology.
• Implement protocol guided care in Research setting; Observe patient condition, record clinical observations, adverse events & reports to PI.
• Have responsibility for research samples to trial protocols.
• Work within clinical trial protocols and to ICH/GCP standards.
• Ability to work without supervision in some areas, e.g. dealing with telephone and personal enquiries from staff, patients and carers, answering queries where possible and ensuring appropriate personnel informed for further action to be taken.

Main Work Activities

• Ensure relevant documents are available for all research patients, adhering to Medical Records tracing systems.
• Report untoward incidents to the appropriate Person in Charge and, where related to patient care, complete the Incident Report Form under the supervision of a Registered Nurse/other Professional.
• Participate in completing all documentation relating to research patient participation, including hospital records, Case Report Forms (CRF’s) and electronic research records.
• Deal with telephone enquiries from staff, patients and carers giving responses where this is within the post holder’s area of knowledge and ensuring that appropriate personnel are informed if appropriate in order for further actions to be taken.
• Interact with trial participants in relation to the requirements of the clinical trials and be able to work without supervision in some areas.
• Under the guidance of a team leader, where necessary provide day-to-day support to other members of staff and members of staff new to the work area.
• Work closely with Clinical Investigators, Research Nurses and other members of research teams to maintain holistic support for all clinical trial participants, thus facilitating a high quality research service.
• Responsible for the taking, preparation, storage and shipping of research samples, to include: Advance preparation for blood, urine and other bodily fluid and tissue sampling of research patients employing correct sample containers, sample labels and sample dispatch.
• Taking samples of venous and capillary blood from patients for the purpose of research pathology testing in line with local and central laboratory protocols and the clinical trial protocols. Prepare blood and urine samples to these protocols, including centrifugation and separating samples.
• Responsible for the preparation and forwarding of correctly, and appropriately, labelled samples to research central laboratories, following mandatory packaging safety requirements.
• Identify eligible patients for recruitment to research from hospital notes, outpatient clinics, patient databases and primary and secondary care screening.
• Identify and highlight local activities that might impact on achievement of the Service’s aims.

Planning and Organisation

• Plan and prioritise own work activities.
• Responsible for facilitation of pharmaceutical company monitoring of the clinical trials being undertaken. Ensuring that visits are co-ordinated with other clinical research staff.

Analysis/Data Inputting

• Assist in the evaluation of patient eligibility, in liaison with other appropriate health care professionals for clinical trial entry, involving the co-ordination of pre-study tests, obtaining results/X-Rays and arranging appropriate appointments as per clinical trial protocols.
• Responsible for the tracking of laboratory results and their documentation in patient’s research records and hospital care notes.
• Responsible for the monitoring and maintenance of clinical stock levels and clerical store levels, ensuring effective and economic use of resources.

Work Environment

• Prepare and maintain research and department equipment as directed.
• Undertake the safe and competent handling of dry ice for frozen shipments of samples.

Additional Requirements

• Fulfil the employees’ duties described in the University’s health and safety policies and co-operate with the health and safety arrangements in place within the department. May be required to undertake specific health and safety roles on request e.g. Display screen equipment assessor, departmental s
• Show a commitment to diversity, equal opportunities and anti-discriminatory practices This includes undertaking mandatory equality and diversity training.
• Comply with University regulations, policies and procedures.

Application Notes

• Please upload a CV and cover letter describing how you meet the person specification for this job in the Resume/CV section of the online application form.
• For any informal queries, please contact Lee Rollins: [email protected]
• Applications close at 00:01am of the closing date listed. We reserve the right to close this vacancy early if we receive sufficient applications.