Research Assistant – Research Nurse

Research Group / Department / School: Clinical Research Facility – School of Medicine, Trinity College Dublin, the University of Dublin

Location:                 Clinical Research Facility, St. James’ Hospital, Dublin 8 Ireland. 

Reports to:              Clinical Nurse Manager 2

Hours of Work:       37.5 Hours

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.

Standard Duties and Responsibilities of the Post 

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.

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.