Clinical Research Nurse Manager CNM1 required for Clinical Trials Unit Dublin Successful applicant will work as a team member to support the work of the Clinical Trials Unit and acts as a member of a multi-disciplinary team liaising with Medical and Nursing staff, Laboratory Staff, Pharmacy Staff, and other Departments as required as well as with Trial Sponsors.
Duties; Screening potential trial patients; review of their medical history, histology, laboratory and radiology reports etc.
Participation in informed consent process.
The CRN goes through in detail with the patient all aspects of participating in a trial, as going forward they are the patients contact.
Providing education, information and support for patients & their families Maintaining trial related logs (screening, informed consent, patient ID logs etc) Responsible for maintaining Investigator Site File Involved in performing trial measurements for example toxicity assessments etc Involved in the ongoing training of site staff, including Consultants, Registrars, Radiation Therapists, Nurses etc.
Involved in the designing and completion of patient pack, Case Report Forms (CRF)and all trial related documentation Patient follow up.
Where possible, for some Clinical Trials this is done by the CRN either by phone or in clinic.
Good Clinical Practice (GCP) training, is a mandatory requirement for all staff involved in clinical trials Ensuring each protocol is in compliance with GCP (Good Clinical Practice) Reporting Serious Adverse Events (SAEs) to Cancer Trials Ireland / Trial Sponsor and Research Ethics Committee (REC) within the required timeline, following up of SAEs to when they are resolved.
Ensuring patients are followed up as per trial schedule Corresponding with Trial Sponsor and International Trial Teams.
Collaborating and communicating with other members of the multidisciplinary team involved in the management of a clinical trial patient.
Possessing good interpersonal skills.
Preparing for and participating in the Initiation of new trials in SLRON and the Initiation of trials developed by SLRON at new sites Preparing amendments of Trial Protocols for submissions to the REC.
Presenting at Study Days/Conferences/Lectures for undergraduate and post graduate Nurses Preparing & Facilitating Monitoring Visits & Audits by Trial Sponsor Liaison with all disciplines involved with Trials - Principal/Chief Investigator, Clinicians, Radiotherapy Physicists, Radiation Therapists, Nurses, and Clinical Trials Unit etc.
Preparing data for publication & writing papers for submission for publication.
Preparing for and participating in Research Team Meetings Practical application of Clinical Trial results into protocol.
Assist in the development of the Irish Research Radiation Oncology Group (IRROG) and achieving Health Research Board grant award deliverables.
REQUIREMENTS: Registered Nurse with a minimum of two years post graduate experience Experience working in the oncology setting Ability to work on your own initiative and as part of a multi-disciplinary team.
Good communication and interpersonal skills Good organisational skills and an ability to establish priorities Versatility and ability to work to deadlines Experience in co-ordinating clinical trials from initiation to closure would be advantageous