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.
- 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.
- 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
Please respond by email with youe interest and up to date CV to firstname.lastname@example.org