Clinical Research Nurse (CNM1)

Summary of Job
The Cancer Clinical Trials & Research Unit is based at Beaumont Hospital, Beaumont Road, Dublin 9. It is led by a Consultant Medical Oncologist (CCTU Lead) and managed on a day to day basis by the Programme Manager. The Clinical Research Nurse is required to manage, co-ordinate and implement various clinical research studies which will be conducted through the CCTU. The appointee will liaise with the relevant research team to provide trial protocol education and to ensure recruitment targets are met, informed consent is obtained and to ensure accurate data collection.

Background Information

The CCTU is funded, in part, by grant funding from the Health Research Board (HRB). The mission of clinical research nurses in the CCTU is to support the practice and development of the cancer clinical research programme for Beaumont Hospital and its affiliated institutions across Dublin North East. Provide specialised nursing care to patients in clinical research and their families, knowledgeable management of the clinical research protocol, effective communication, and staff education, working within a team to achieve high standards in patient care and clinical outcomes. The team of Clinical Research Nurses, under the direction of the Programme Manager , work closely with Oncologists, Haematologists, Clinical Data Managers, Clinical Trial Pharmacists, Administrative Assistant, Data Clerk and the Multi-disciplinary Team.

Key Duties and Responsibilities

Professional:
1. Maintain professional registration.

2. Undertake further education as appropriate to keep updated with changes within the field of Clinical Research.

3. Attend and participate in: In service and staff education, Staff conferences appropriate outside conferences and/or other professional development activities.

4. Act as an advocate for clinical trial participants.

5. Participate in internal and external working groups to develop and share evidence based / best practice, locally, nationally and internationally if required.

6. Act as an ambassador for the CCTU and for Clinical Research Nurses, taking opportunities to promote both areas and clinical research in general.

Research:
1. Work within the standard operating procedures and research protocols associated with industry and academic clinical research activities in accordance to Good Clinical Practice.

2. 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.

3. Actively participate in the implementation of clinical investigations and trials.

4. Assist in ensuring the overall smooth running of clinical research in line with best practice, ICH-GCP and within the scope of the protocol.

5. To ensure participant confidentiality and dignity is assured and maintained at all times during a clinical trial/research project.

6. Liaise with other members of research team and assist with maintenance and upkeep of clinical research documentation, including: site files, case record forms, monitoring arrangements, data correction, data collection and data entry.

7. 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.

8. Liaise with Study monitors to assist with internal and external Quality Assurance and Audit.

9. Review proposed research protocols and provide input to site study feasibility reports (where necessary)

10. Attend investigator meetings as appropriate relative to studies assigned to you.

11. Ensure prompt management of all study related correspondence (in line with SOP’s)

12. Assist in the preparation of studies for Internal / Sponsor / HPRA audits as required.

13. Provide a high standard of nursing care within a multi-professional research team.

14. Ensure participant treatment is in accordance with clinical research protocols.

15. Screen participants to identify suitable study candidates

16. Ensure that participants are fully informed of all details pertaining to the clinical trial/research project prior to their recruitment.

17. Carry out other duties as appropriate to the post as may be assigned from time to time by the Programme Manager and/or Consultant Oncologist/Haematologist and/or CNM2.

Clinical Practice responsibilities will include:

1. Provide nursing expertise and care to participants participating in a clinical trial.

2. Ensure participants have an understanding of their disease and the proposed research and standard treatment options.

3. Work with a Multidisciplinary Team in evaluating and treating clinical problems, as they arise in the research settings.

4. Be competent in phlebotomy procedures or be willing to train.

5. Adhere to nursing policies and procedures for Beaumont Hospital.

6. Ensure continuity of patient care by liaising with outside health care professionals and/or other institutions where necessary.

7. Where patients are referred for clinical trial participation from other hospitals, adequately communicate with referring institution in the management, care and follow up of referred patients.

8. Facilitate effective communication of complex study information with all relevant research personnel, including: medical, nursing, administrative and pharmacy staff

Quality Assurance

1. Assist in the future development and evolution of Standard Operating Procedures (SOPs), for use by all research staff in the CCTU.
2. Maintain clinical and administrative records and reporting arrangements.
3. Provide a high quality efficient and effective service, respecting the needs of each participant.

4. Provide feedback to Programme Manager and Medical lead in monitoring the service ensuring it reflects current needs and implement changes where required and agreed.

5. Promote effective teamwork, initiate and support management of change within the CCTU .
6. Ensure safe use of all CCTU equipment.

Education & Development:
1. Participate in teaching programmes for CCTU staff and the broader clinical research team including informed consent, randomisation and specimen collection.
2. Recognise and use spontaneous and formal learning opportunities and share knowledge and experience with other staff.
3. Continue to maintain and develop personal and management skills by undertaking mandatory and other training as required.

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

Note: as the Oncology/ Haematology services across the Dublin North East region continues to expand and evolve, it is likely that flexibility in regard to the allocation of specific duties will be necessary. Accordingly, the list of duties detailed above is not intended to be exclusive or restrictive, duties may be added or withdrawn but any such alterations will take place after consultation with the appointee. The appointee will report to the CCTU Programme Manager. Flexibility with working hours may be required to suit the changing needs of the CCTU.

Selection Criteria:
Selection criteria outline the qualifications, skills, knowledge and/or experience that the successful candidate demonstrates for successful discharge of the responsibilities of the post.
Applications will be assessed on the basis of how well candidates satisfy these criteria.

Mandatory Requirements:

1. Statutory Registration, Professional Qualifications, Experience, etc
(a) Eligible applicants will be those who on the closing date for the competition:

(i) Are registered in the relevant division of the Register of Nurses & Midwives maintained by the Nursing and Midwifery Board of Ireland [NMBI] (Bord Altranais agus Cnáimhseachais na hÉireann) or entitled to be so registered.

And

(ii) Have at least 3 years post registration fulltime experience (or an aggregate of 3 years post registration full time experience) of which 1 year post registration full time experience (or an aggregate of 1 years post registration full time experience) must be in the speciality or related area.

And

(iii) Have the clinical, managerial and administrative capacity to properly discharge the functions of the role.

And

(iv) Candidates must demonstrate evidence of Continuing Professional Development.

2. Annual registration

• On appointment, Practitioners must maintain live annual registration on the relevant division of the Register of Nurses and Midwives maintained by the Nursing and Midwifery Board of Ireland (Bord Altranais agus Cnáimhseachais na hÉireann).
• Confirm annual registration with NMBI to the HSE by way of the annual Patient Safety Assurance Certificate (PSAC).

3. Health
Candidates for and any person holding the office must be fully competent and capable of undertaking the duties attached to the office and be in a state of health such as would indicate a reasonable prospect of ability to render regular and efficient service.

4. Character
Candidates for and any person holding the office must be of good character.

Desirable Knowledge & Experience:

• Have excellent communication skills - requires attention to detail and meticulous record keeping.
• 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.
• Knowledge of ICH GCP desirable but not essential (ICH GCP training will be provided)
• Have proven clinical skills such as venopuncture, 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.
• Ability to work within scope of practice in a confident and safe manner, ensuring professional accountability and adherence to hospital policies and protocol.
• Ability to work independently, self-directed but also works well within a team and under supervision and direction.
• Have good IT skills including Microsoft Office, email etc.
• Experience in the field of clinical trials of medicinal products or medical devices.
• Experience in Oncology and/or Haematology
• Experience in translational “bench to bedside” research
• Certificate in Good Clinical Practice (ICH-GCP)

If an appointee has previously been employed in the Civil or Public Service and that appointee is entitled to or in receipt of a pension from the Civil or Public Service or where a Civil/ Public Service pension comes into payment during the appointee’s re-employment that pension will be subject to abatement in accordance with Section 52 of the Public Service Pensions (Single Scheme and other Provisions) Act 2012.

Please note: In applying for this position you are acknowledging that you understand that the abatement provisions, where relevant, will apply. It is not envisaged that the employing Department/ Office/ Body will support an application for an abatement waiver in respect of appointments to this position

Further Information for Candidates Supplementary information:

Informal Enquiries ONLY to: (No applications will be accepted through this email address)