The Clinical Research Platform (CRP) is an Research Irish Site Management Organization (SMO) and enabler of research and clinical trials. We enable Clinicians to become involved in clinical research opportunities for some of the world’s leading pharmaceutical and biotechnology companies.
We are committed to providing our expertise in clinical trials and site management to ensure the best quality and care in executing clinical research here in Ireland.
Due to continued expansion and partnership with Tallaght University Hospital we are currently seeking a CNM1 post within TUH to oversee and support the expansion of clinical and academic research within the hospital. The successful applicant will work as a team member to support the work of the developing Clinical Trials Unit and act 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.
· 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 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.
· Patients follow up.
· Good Clinical Practice (GCP) training is a mandatory requirement for all staff involved in clinical trials.
· Reporting Serious Adverse Events (SAEs) to 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 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.
REQUIREMENTS:

• Registered nurse with a minimum of two years post graduate experience.
• At least 2 years’ experience working in Clinical Research.
• 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.

Job Type: Full-time
Pay: €45,000.00-€60,000.00 per year
Schedule:

• Monday to Friday

Work authorisation:

• Ireland (required)

Work Location: In person