Clinical Trials Practitioner

Salary Range:

£29,588.00 - £32,080.00

We are committed to equality, diversity and inclusion, creating a community where colleagues feel respected and valued. We aim to reflect the diversity of our students and communities, and to strengthen our university through collaboration and diverse perspectives, across all roles at the University.

Job Description

Job Title: Clinical Trials Practitioner

Faculty/Professional Directorate: Faculty of Health Science,

Subject Group/Team: Diabetes and Endocrinology, Hull York Medical

Reporting to: Chair in Endocrinology

Duration: Fixed term for 12 months

Job Family: Administration

Pay Band: 5

Benchmark Profile: Administration Band 5

Details Specific to the Post

We are recruiting for x2 Clinical Trials Practitioner.

Background and Context

The post holder will work within the purpose built clinical trials unit within Academic Diabetes, Endocrinology and Metabolism based in the new Allam Diabetes Centre at Hull Royal infirmary and to help make a positive impact to people living within the region.

The Clinical Trials Practitioner will support a varied portfolio of clinical and applied health studies as well as pilot courses of diet and lifestyle invitations. 

The post holder will work closely with communities to increase representation across our portfolio of work, specifically in the field of obesity and its associated co morbidities.

The post holder will be responsible for identification and recruitment of suitable candidates to participate in clinical trials specifically individuals living with obesity and overweight. Further responsibilities include the management and facilitation of the clinical trials, including clinical work and technician tasks ensuring data is correctly gathered and recorded under the guiding principles of GCP

Specific Duties and Responsibilities of the post

The post holder will 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.  To have responsibility for research samples to trial protocols. To 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.

GENERIC JOB DESCRIPTION

The job duties and responsibilities listed below are intended to describe the general nature of the role.  The duties and responsibilities and the balance between the elements in the role may change or vary over time depending on the specific needs at a specific point in time or due to changing needs in the department.  Candidates should note that there may not be an immediate requirement to carry out all the activities listed below.

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 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.

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.