Clinical Research Practitioner - Community Research Team

Detailed job description and main responsibilities

1.      Clinical 

1.1.   Assist research nurses/ACP’s/Clinicians in delivery of patient care to research participants. 

1.2.   Support and co-ordinate obtaining and processing of blood and tissue samples in the clinical setting as well as optimising recruitment via clinics and MDT’s. 

1.3.   Work alongside research nurses ensuring samples are collected and recorded per protocol. 

1.4.   Review and record treatments, adverse events, and response to treatment to relevant study documentation including source data and case report forms including electronic data entry. 

1.5.   Plan, prepare and participate in monitoring visits and respond to trial data queries. 

2.      Communication 

2.1.   To function as a member of the Research and Innovation Clinical Trials Team to provide dedicated clinical trials support to research teams across NUH. Working within a multi-disciplinary team, to co-ordinate a caseload of patients participating in local, national, and international clinical trials in various treatment types. 

2.2.   Disseminate information to consultants regarding new trials on the National Institute of Health Research trial portfolio as well as non-adopted clinical trials, to enable optimal patient recruitment. 

2.3.   Ensure ethics and R&D approval and indemnities are in place before recruitment of first patients to a newly set up trial. Facilitate the set-up of trials on site i.e. SSI submission via IRAS account, liaise with trial centre and other relevant staff to organise trial set-up visits. 

2.4.   Liaise with clinical teams to organise and ensure that trial specific investigations are undertaken as and when required, obtain the results, ensure eligibility, and randomise the patient. 

2.5.   Liaise with medical staff to record organise and ensure the timely administration of treatment and any necessary follow up investigations and visits. 

2.6.   Liaise with histopathology ensuring tissue samples are stored via Tissue Bank guidelines, organising storage and catalogue of samples kept. 

2.7.   To ensure effective communication with support departments to request and obtain specific trial related information. E.g. Radiology copy scans, histological status, and tissue samples. 

2.8.   Organise the collection, storage, and shipment of protocol specific samples. Explain, dispense, and collect patient quality of life questionnaires and diaries. Liaise with designated Pharmacist to co-ordinate the availability and dispensing of trial drugs if required. 

2.9.   Provide information to allow for invoices to be raised for payments where appropriate. 

2.10.    Contribute to and supply verbal and written information on the team's portfolio of trials and the number of patients recruited to the R&I team, hospital/university staff, local/Network meetings, regulatory bodies etc., as required. 

3.      Managerial 

3.1.   Maintain patient’s records and accurately document data collected in case report forms and medical notes, ensuring correct storage, and maintaining confidentiality. 

3.2.   Actively and independently participate in trial set up including gaining relevant permissions and submitting SSI forms. 

3.3.   To record trial activity on data systems and plan yearly Audits on recruitment as required by the clinicians. 

3.4.   Forward trial data in a timely manner to the trial co-ordinating centre and liaise with their personnel, as necessary. 

3.5.   Attend local and national meetings and feedback to members of the team. 

4.      Professional 

4.1.   Work alongside medical and nursing staff to assist in the informed consent process by giving information to patients concerning trials and allowing them to reach a fully informed decision about participation. 

4.2.   To have specific and specialist knowledge of the patient pathway with regard to individual patients' diagnosis and the treatment options that are available to them.

 4.3.   In discussion with the team leader, report adverse and serious adverse events to the relevant trial centre and site personnel, within the agreed timelines to ensure trial procedures and patient safety parameters are met. 

4.4.   Act as a contact point for the patient and their relatives. Maintaining contact with and providing ongoing information and support to the patient in a sensitive and professional manner. Refer to other specialists as required in order to provide optimal patient care. 

4.5.   Participate in Continued professional development and undertake additional training as required per Knowledge Skills Framework and research staff competence framework. 

5.      Speciality Specific 

5.1.   Assist in the review of trial protocols and identify resource implications for the site. 

5.2.   Identify patients suitable for entry into clinical trials by attending clinics and Multi-Disciplinary Team meetings. 

5.3.   Ensure trial protocols are adhered to and that all personnel involved in trials are aware of any changes or protocol amendments. Liaise with trial centres and relevant departments in order to promote a good working environment and ensure the smooth running of clinical trials for patients. 

5.4.   Work, at all times, according to regulations described in NUH Policies, procedures and Standard Operating Procedures, Good Clinical Research Practice and European Directive and R&I Standard Operation Procedures. 

NOTE:  The duties and responsibilities of the post will be undertaken in accordance with the policies, procedures, and practices of the Nottingham University Hospitals NHS Trust, which the Hospital will amend from time to time. Copies are available on each Ward and Department. It is the individual’s responsibility to keep up to date with these and other policy documents.

GENERAL DUTIES

In addition to the key job responsibilities detailed in this job description all employees at Nottingham University Hospitals NHS Trust are expected to comply with the general duties detailed below: 

Infection Control

To maintain a clean, safe environment, ensuring adherence to the Trust’s standards of cleanliness, hygiene, and infection control. 

Safeguarding children, young people, and vulnerable adults

Nottingham University Hospitals is committed to safeguarding and promoting the welfare of children, young people, and vulnerable adults.  All staff and volunteers are therefore expected to behave in such a way that supports this commitment.

 Information Governance

All staff have an individual responsibility for creating accurate records of their work and for making entries into and managing all NHS records effectively in line with the Health Record Keeping Policy and other Health Records and Corporate Records Management policies and procedures in order to meet the Trust’s legal, regulatory and accountability requirements.

 Health and Safety

To take reasonable care to prevent injury to themselves or others who may be affected by their acts or omissions. 

To co-operate fully in discharging the Trust policies and procedures with regard to health and safety matters.

To immediately report to their manager any shortcomings in health and safety procedures and practice. 

To report any accidents or dangerous incidents to their immediate manager and safety representative as early as possible and submit a completed accident/incident form. 

To use protective clothing and equipment where provided. 

Whilst the aim of the Trust is to promote a co-operative and constructive view of health and safety concerns in the organisation, all staff must be aware that a wilful or irresponsible disregard for safety matters may give rise to disciplinary proceedings. 

Governance

To actively participate in governance activities to ensure that the highest standards of care and business conduct are achieved.

 Health and Wellbeing

Employees are expected to take all reasonable steps to look after both their physical health and mental health. To support employees to achieve this NUH offers a wide range of health and wellbeing activities and interventions. The full programme can be viewed at on the staff intranet. 

Line managers are expected to encourage and support staff to look after their health and wellbeing, including the release of staff to attend health and wellbeing activities and interventions. 

General Policies Procedures and Practices

To comply with all Trust policies, procedures, and practices and to be responsible for keeping up to date with any changes to these.