Clinical Trials Practitioner

Overall Purpose of the Role

Roles at this level work within established processes and procedures, with minimum day-to-day supervision under the guidance of a team leader.

The role holder will:

• Provide support to staff, students and more senior colleagues. The role will involve maintaining systems and/or undertaking routine tasks that support the working of teams, processes and/or projects.
• Require the relevant knowledge which may be gained through experience and on-the-job training.

Main Work Activities

Communication

• 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.

Teamwork

• 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.

Service Delivery

• 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.
• Preparation and observation of patients participating in research, including observation of weight, body measurements, blood pressure, toxicity, quality of life and other appropriate measurements as required. Record and inform team leader of observations.
• Be able to teach patients on the use of insulin and growth hormone pen devices, inhaled insulin devices and similar technologies. Be familiar with and give patients training in the use of home blood glucose monitors. Be aware of normal blood glucose range.

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 coordinated with other clinical research staff.

Analysis/Data Inputting

• Assist in the evaluation of patient eligibility, in liaison with other appropriate healthcare professionals for clinical trial entry, involving the coordination 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.

Additionally the post holder will be required to:

• 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 safety officer, fire warden.
• 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.

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 more information regarding the specific duties for the role please view the job description here.

Applications close at 00:01am of the closing date listed. We reserve the right to close this vacancy early if we receive sufficient applications. If you are interested in this role, please submit your application as early as possible.