Provision of Research Nurses

Klinikos understands that the difference between a poor performing Investigator Site and a successful one can often be down to the quality of study site personnel; specifically, the research nurse.

Surprisingly, some Investigators still try to participate in research projects without the help of a research nurse and then wonder why their recruitment, organisation and paperwork is poor and unacceptable to the Sponsor.



Klinikos would never submit a study site to a Sponsor that did not have at least one research nurse (RN) or Study Site Co-ordinator (SSC) as the time constraints and organisational pressures on the Principal Investigator (PI) negates their sole participation in a study.

The Problem

Too often, Klinikos has witnessed the results of a site that has been approved and initiated without RN or SSC assistance resulting in one or more of the following:

• Poor patient recruitment and retention
• Poor filing and organisation of essential documentation at site
• Poor CRF completion
• Poor source documentation
• Well above average study query generation
• Insufficient liaison with Ethics Committees

The Solution

A competent RN or SSC at the Investigator Site is invaluable to the PI as they:

• Can support Local regulatory submissions (MREC, LREC and R&D approval)
• Assess and resolve local issues
• Assist in the development of recruitment and patient identification plans
• Manage Essential Documentation and patient visits
• Communicate with the Sponsor
• Perform 80% of the patient protocol requirements

Klinikos has a bank of Research Nurses throughout the UK that are available to work on a part time basis to assist a Study Site in the management of their trial.

Procedure

On request, Klinikos can provide CVs of available RNs for review. If you like the CV, we can arrange for you to talk with the RN directly without Klinikos being involved. If you wish to proceed and it is practical, a further interview can be arranged face to face. Once you have made your decision, the RN can work directly under your control without any Klinikos involvement in the running of the study.

Contracts

The RN can be under your direct control for project related activities and Klinikos would handle the financial administration and have a direct contract with the RN and arrange payments to the RN. Klinikos would have a contract with your company for the services of the RN.