Post Summary

This position will involve working with a team of research nurses in an established Clinical
Research Facility at St James’s Hospital. Research projects will range from investigator lead
studies to Clinical trials involving investigational medicinal products across a wide disease
spectrum. Dynamic, flexible nurses with a strong clinical skill set are invited to apply for this
position.

Research responsibilities will include:

• To work within the standard operating procedures and research protocols associated
with industry and academic clinical research activities in accordance to Good Clinical
Practice.
• To play a proactive role in driving on-going clinical research projects through participant
recruitment, participant follow-ups, identifying problems early and regular feedback with
Principal Investigator and research team.
• To actively participate in the implementation of clinical investigations and trials.
• To assist in ensuring the overall smooth running of clinical research in line with best
practice, ICH-GCP and within the scope of the protocol.
• To arrange study specific research meetings if necessary, including staff notification,
completion and writing of minutes where applicable.
• To ensure participant confidentiality and dignity is assured and maintained at all times
during a clinical trial/research project.
• To take responsibility for maintenance and upkeep clinical research documentation,
including: site files, case record forms, monitoring arrangements, data correction, data
collection and data entry.
• To complete (with the help of the sponsor company if necessary) all ethical and regulatory
procedures (submissions, query resolution etc.) for the clinical trial studies you are
assigned.
• To review proposed research protocols and provide input to site study feasibility reports
(e.g. annual site participant numbers, equipment / test availability etc.)
• To attend investigator meetings as appropriate relative to studies assigned to you.
• To ensure prompt management of all study related correspondence.
• To prepare your studies for Internal / Sponsor / HPRA Health Products and Research
Authority audits as required.
• To ensure that participants are fully informed of all details pertaining to the clinical
trial/research project prior to their recruitment.
• To screen participants to identify suitable study candidates.
• To ensure that all assigned studies are completed to the highest standards in accordance
with ICH-GCP, HPRA/EU Directive requirements.
• To carry out other duties as appropriate to the post as may be assigned from time to
time by the CRF Director and/or the CRF CNM2/ADON.

Clinical Practice responsibilities will include:

• Provide nursing expertise and care to participants participating in a clinical trial.
• Ensure participants have an understanding of their disease and the proposed research
and standard treatment options.
• Work with a Multidisciplinary Team in evaluating and treating clinical problems, as they
arise in the research settings.
• Be competent in phlebotomy procedures or be willing to train.
• Adhere to nursing policies and procedures for TCD and St. James’s Hospital.
• Ensure continuity of patient care by liaising with outside health care professionals, and
those who are involved in clinical work.
• Use agreed protocols to deal with referrals and enquiries from other hospitals
• Promote a safe clinical environment for patients, visitors and staff with due regard to
Health and Safety and Risk Management issues.

Professional development

• Maintain professional registration.
• Undertake further education as appropriate to keep updated with changes within the
field of Clinical Research.
• Attend and participate in: In service and staff education, Staff conferences appropriate
outside conferences and/or other professional development activities
• Identify nursing/midwifery research opportunities
• Take responsibility for own professional development and updating including maintaining
a record of activities.

Quality Assurance

• Help maintain the system for recording clinical activity.
• Demonstrate commitment to evidence-based practice.
• Maintain clinical and administrative records and reporting arrangements.
• Provide a high quality efficient and effective service, respecting the needs of each
participant.
• Continually monitor the service ensuring it reflects current needs and implement change
where required.

Other duties and responsibilities may be specified from time to time at the discretion of the
management.

Qualifications
Knowledge & Experience (Essential & Desirable)

• Must have current registration as a general nurse with the Nursing and Midwifery Board
of Ireland.
• Have a minimum of 4 years post registration experience in an acute hospital setting
(within the last 7 years).
• Have proven clinical skills such as venipuncture, current IV policy, basic life support
training and ability to provide safe and high-quality nursing care to a wide variety of
research participants across different disease spectrums.
• Have experience of working on clinical trials or within a research setting.
• Ability to work within scope of practice in a confident and safe manner, ensuring
professional accountability and adherence to hospital policies and protocol.
• Have excellent oral and written communication skills – requires attention to detail and
meticulous record keeping.
• Have excellent organizational and ‘problem solving’ skills.
• Ability to work independently, self-directed but also works well within a team and under
supervision and direction.
• Ability to monitor performance of self and others against set standards.
• Have the interpersonal skills required to integrate as part of a diverse research team and
the ability to relate to a broad spectrum of research participants.
• Have good IT skills including Microsoft Office, email etc.
• Share knowledge and expertise with other staff.
• Develop specialist skills to support research studies, under supervision.
Skills & Competencies
• Experience in the field of clinical trials of medicinal products or medical devices.
• Experience in translational “bench to bedside” research
• Certificate in Good Clinical Practice (ICH-GCP)
IV Cannulation

Application Procedure

Applicants should submit a full Curriculum Vitae to include the names and contact details of 2
referees (including email addresses), to:-
Derval Reidy reidyde@tcd.ie

Further Information for Applicants:

Information Packet with full post specification: Download here
URL Link to Area www.tcd.ie
URL Link to Human Resources https://www.tcd.ie/hr/

Location

Dublin, Ireland

Closing Date

01 May 2025

Location

Cork, Ireland

Closing Date

31-Jan-2024 @ 12:00