NursingNetUK

Detailed job description and main responsibilities

Clinical Responsibilities

• Work in conjunction with the Senior Research Nurse/Clinical Trials Coordinator to manage a caseload of patients, whilst working as part of a multidisciplinary team. Maintain effective communication with patients, carers and professionals to ensure service delivery. Assist in screening patients suitable for entry into clinical trials. This may include attending clinics and Multidisciplinary Team (MDT) meetings.
• Identify patients suitable for entry into clinical trials by attending clinics (screening notes/consultant referral) and Multidisciplinary Team (MDT) meetings.
• With other members of the healthcare team, ensure patients are fully informed prior to entry in any clinical trial programme.
• Assist in consenting, randomising, allocating of treatment of patients.
• Evaluate patient eligibility for clinical trial entry, co-ordinating pre-study tests, obtaining results and arranging appropriate appointments according to trial protocol.
• Act as a resource and support to patients and their relatives, explaining practical aspects of clinical trials, assisting and supporting local nursing teams.
• Coordinate the collection of any blood samples required as part of the clinical trials and ensure safe and appropriate storage of specimens, in conjunction with local nursing teams.
• Support the administration of trial drugs (commensurate with education and training), be aware of and report any unusual side effects, in association with local nursing teams.
• Maintain adequate patients’ records and ensure all relevant information is documented in the patient’s medical and nursing notes.
• Responsible for accurate completion of Case Report Forms (CRFs).
• Responsible for the collection, co-ordination and computerisation of data generated from the clinical trials. 
• Provide continuity of care for patients and their carers throughout the trial programme.  Provide specific advice and support as appropriate.
• Implement and adhere to the principles of GCP (Good Clinical Practice) as set out in the Clinical Trials Regulations.
• If appropriately trained, keep up to date with current practices for cannulation, phlebotomy and care of patients with Central Venous Access lines.  
• Act as a resource for liver based research.

 Portfolio Management and Development

• Assist in the review of trial protocols and identify resource implications for the site.
• Set up and maintain the TMF/ISF with essential documents.
• Help organise initiation meetings.
• Liaise with and assist the medical team/sponsor organisation in - on-study treatment and follow up of patient
• Ensure CRFs are completed accurately and in a timely manner.
• Ensure SAEs are recorded and reported in accordance with the protocol and/or sponsor’s SOP.
• For network trials, ensure that accrual data is uploaded onto the NIHR CRN portal using the EDGE clinical trials database. Collect and provide information to allow for invoices to be raised for payments where appropriate
• Liaise with other departments and wards at the site/s, in order to promote a good working environment, integration of research within and open channels of communication.
• Inform appropriate medical personnel and departments of portfolio of clinical trials.
• Participate in the presentation of research findings within the Clinical Research Network South London and outside agencies as appropriate.
• Report adverse incidents and near misses via the Trust’s online incident reporting form.
• Coordinate multi-centre trials (where appropriate).  Together with the Kings Health Partners Clinical Trials Office (KHP CTO):
  • Ensure all relevant documents and approvals are in place at each site prior to subject recruitment.
  • Liaise with participating sites, identifying key staff and updating them on trial processes/changes to the protocol and ensuring centres are able to comply with the study protocol.
  • Help conduct initiation meetings (if required)
  • Collect data from sites, raise data queries and ensure data queries are resolved.

Training and Development

• Attend the KHP CTO, NIHR CRN and CRN South London training programmes and other relevant education and training days/programmes as appropriate.
• Attend investigator/initiation meetings and conferences when required.
• Maintain awareness of current advances in hepatology treatments, research and nursing practice and use this knowledge to maintain high standards of care for Nurse trial patients.
• Disseminate research by assisting in the preparation of posters/research papers for meetings, conferences and publications. Also circulate trial information and carry our presentations locally.