We are looking for a new research nurse to join our busy team in a hospital in County Donegal. Experience of clinical research is preferable, but not essential. However, applicants will be expected to have a genuine interest in the clinical research area, and looking to commit to a career change.

MAIN PURPOSE:

The research nurse will play a pivotal role in the coordination of clinical trials. Under the supervision of the research manager the post holder will be involved in executing all activities relating to the clinical studies, ensuring compliance with regulatory requirements.

MAIN DUTIES AND RESPONSIBILITIES:

Research responsibilities will include

· Working within CRP standard operating procedures and research protocols/plans ensuring the overall smooth running of clinical trials/Investigations in accordance with Good Clinical Practice (GCP) and applicable regulatory and ethical requirements.

· Study Coordination and management of multiple research projects

· Screening of patients to identify potential study candidates, evaluation and enrolment of suitable participants in clinical research trials/investigations under the direction and supervision of the Principal Investigator (PI).

· Management and accountability for Investigational Medicinal Product/Device (IMP/IMD)

· Playing a proactive role in driving on-going clinical research projects through participant recruitment, participant follow-ups, safety reporting, early identification of potential problems and regular feedback with Principal Investigator and research team.

· Ensuring the maintenance and upkeep of clinical research documentation, including site files, case record forms, monitoring arrangements, data correction, data collection and data entry as per GCP/protocol and data protection requirements.

· Ensuring prompt management of all study related correspondence.

· Ensuring research data is accurate and verifiable and is collected, stored and handled on site in compliance with the protocol and data protection requirements

· Preparation for and participation in monitoring visits and Internal/Sponsor/Regulatory audit/inspection as required

· Development and maintenance of strong relationships with research partners, key stakeholders and team members by acting as the first point of contact on a variety of research projects and liaising with project collaborators, stakeholders, and staff.

· Playing a pivotal role in educating relevant research and clinical staff on current and upcoming clinical trials/investigations

Clinical Practice responsibilities will include:

· Provide nursing knowledge, expertise and care to patients participating in a clinical trial. Ensure that patients are fully informed of all details pertaining to the clinical trial/research project prior to their recruitment as per GCP.

· Ensure patients understand their disease and the proposed research and standard treatment options.

· Attend out-patient clinics for the purpose of optimising patient recruitment to clinical research studies.

· Maintain competence in the area of relevant national and European standards including data privacy and ethical standards and regulations

· Ensure competence/training in all designated research activities prior to carrying out such activities on research participants

· Performs study procedures (e.g., Administration of IP. Oral, SC, IM, monitoring of infusions, Phlebotomy, obtain and process biological specimen samples, obtain ECG recordings, vital signs, Spirometry and safety assessments) as required by study protocol under the supervision of the Principal Investigator (PI)

· Ensure continuity of patient care by liaising with outside health care professionals, and those who are involved in clinical work where applicable.

· Use agreed processes to deal with referrals and enquiries from other hospitals

· Carry out other duties as appropriate to the post as may be assigned from time to time by line manager/CRP management team

Professional development

· Maintain professional registration

· Take responsibility for own professional development and skills updating including maintaining a record of training activities and experience gained.

· Work with PI and CRP management team to ensure the safe delivery of care to patient participating in the clinical study

· Work closely with CRP’s Management to ensure that appropriate quality documentation and performance measures are in place for improved processes.

The post holder requires

· Degree in Nursing and a minimum of 3 years’ nursing experience

· Current registration with the Nursing and Midwifery Board of Ireland (NMBI)

· Proven clinical skills such as 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.

· Excellent oral and written communication skills.

· Good organizational, analytical/critical thinking and problem-solving skills with an ability to prioritize tasks/workload and meet deadlines

· Evidence of accuracy and attention to detail

· Knowledge of Microsoft office applications and willingness to develop computer skills further

· Knowledge of relevant data protection requirements

· Understanding of Good Clinical Practice

· Ability to work autonomously or as part of a team and to demonstrate initiative.

It would be desirable that post holder would have:

· Have experience of working on clinical trials or within a research setting

· Be competent in phlebotomy procedures

· Biological sample handling and processing experience with IATA certification

Job Type: Full-time

Pay: €40,000.00-€56,000.00 per year

Education:

Bachelor's (required)

Work Location: In person

CRP

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Clinical Research Nurse