Organisation/Company University College Cork Department HR Research Research Field Medical sciences » Cancer research Researcher Profile Recognised Researcher (R2) Positions Research Support Positions Country Ireland Application Deadline 31 Oct 2025 - 12:00 (Europe/Dublin) Type of Contract Temporary Job Status Full-time Is the job funded through the EU Research Framework Programme? Not funded by a EU programme Is the Job related to staff position within a Research Infrastructure? No
Offer Description
The CNM II (CUH) will work under the direction of the Site Operations Manager (SMOM) and as part of a multidisciplinary team, supporting commercially and academically sponsored clinical trials in compliance with ICH-GCP Guidelines and applicable regulations. This will include both regulated and non-regulated clinical trials. Previous experience working in regulated studies will be an advantage.
Candidates will predominately be based in Cork University Hospital. The candidate may on occasion be required to support studies at other sites. Candidates must be flexible with working hours to accommodate evening and weekend visits and candidates must be willing to take part in an out of hours on call service for the CRF-UCC as required. Candidates must have strong interpersonal and leadership qualities and be capable of developing and mentoring less experienced staff. The successful candidate will be expected to take a leading role in staff education programmes in the CRF-UCC.
A Research Support Officer Clinical will work under the direction of a Principal Investigator/Project Leader to manage, co-ordinate and implement various clinical research studies to support the research project/area. This title will apply to a person of appropriate qualifications e.g. BSc, MSc of PhD employed for the purpose of supporting a research project/area.
The post of CNM II has a pivotal role in service planning, co-ordinating, and managing activity and resources within the clinical area. The main responsibilities are: quality assurance, resource management, staffing and staff development, study delivery, practice development, risk management, facilitating communication and professional / clinical leadership.
The CNM II will play a key role in the evaluation of proposed studies, will be responsible for feasibility assessments, budgetary aspects, protocol implementation, study management and the integration and effective communication between other trial sites. He/She will work with the CRF-UCC team, the sponsors, the institutions, and other partners to drive study set-up, coordination and effective implementation. The CNM II will help supervise work schedules for staff working on CRF-UCC research projects and assist the Site Operations Manager (SMOM) in the scheduling the workload of clinical research staff. They will have general oversight to ensure successful recruitment and the high-quality timely completion of clinical trials.
KEY DUTIES AND RESPONSIBILITIES
PROFESSIONAL
* Build and maintain relationships with investigators, hospital staff, sponsors, CROs, and local stakeholders
* Identify potential risks related to study conduct and site operations, mitigate and/or manage where appropriate, and escalate when required to CRF-UCC Risk Management process
* Contribute towards departmental research meetings.
* Provide a high standard of clinical research work within a multi-professional research team.
* Ensure clinical research work is conducted in accordance with clinical research protocols.
* To regularly assess the needs of the research project/area and effect any changes as required.
* To participate in internal and external working groups to develop and share evidence based best practice.
* To undertake research, working under the direction of a Principal Investigator or their nominee in clinical areas to support the research project/area.
RESEARCH
* Manage, coordinate, organize and implement basic science and clinical trial protocols to support the research project/area.
* To ensure accurate collection and maintenance of all study records, including those of team members.
* To actively participate in recruiting patients for trials, liaising with other professional groups and research staff to achieve this as required.
* When appropriate, assist in the development of Standard Operating Procedures (SOPs) to support the research project/area.
* Facilitate effective communication of complex study information with all relevant research personnel, including: medical, nursing, administrative and pharmacy staff, as required.
* Cover roles within the portfolio and act as a delegate for peers within the CRF as requested, stepping in when appropriate (e.g., overseeing specific trials or teams).
MANAGEMENT
* Participate in hiring decisions, managing staffing levels and coordinating day-to-day workloads of staff to meet study demands.
* Manage, supervise, and support PI's and site staff to ensure effective delivery of clinical trials. Build & maintain external relationships on behalf of the CRF.
* Ensure staff adhere to CRF-UCC and local SOPs, as well as in accordance to GCP for the running of clinical trials through appropriate training, oversight, and facilitating internal quality reviews.
* Ensure effective work distribution across staff to achieve optimum results.
* Manage resources
* Provide professional / clinical leadership and oversee the workload of CRF-UCC clinical operations staff.
* Facilitate communication
* Respond to CRF-UCC alerts and/or unexpected issues that may arise in a timely fashion.
* Ensure that clinical research activity is undertaken to a high standard and in line with Good Clinical Practice Guidelines and regulatory requirements.
* Work collaboratively and innovatively within the organisational research infrastructure.
* Liaise effectively with sponsor representatives, Contract Research Organisation representatives and associate ancillary staff and external vendors in trial set up, conduct and close out.
* Compile information for and accurately complete project reports for delegated studies.
* Assist in feasibility assessments, budget breakdown discussions, and contract negotiations in trial set up.
* Contribute to clinical documents (protocols, Investigator Brochures, Study Manuals, CRF-UCC completion guidelines, SOPs, monitoring plans, etc.) and project reviews.
* Coordinate team meetings and ensure good communication within the team.
* Manage own workload, patient interviews and co-coordinating investigations and procedures and arranging any follow up necessary for complex research trials, as required.
* Develop effective working partnership with staff, ensuring the two-way flow of all necessary documentation and information.
* Report adverse events to Principal Investigator or his/her nominee and ensure completion of appropriate documentation.
* Inform the Principal Investigator or his/her nominee of any untoward incidents or problem areas affecting the research project/area.
* Compile information for and accurately complete project reports for delegated studies.
* Promote effective teamwork, initiate and support management of change within the research project/area, as required.
* Ensure safe use of equipment in the research area.
EDUCATION & DEVELOPMENT
* Facilitate initial and ongoing education & training of site personnel in clinical research protocols, site and regulatory requirements.
* Develop educational material and delivery of regular CRF-UCC educational meetings for research staff.
* Provide mentorship and ongoing training for research staff.
* Participate in teaching programmes for staff as required.
* Act as role model, encouraging staff to develop new ways of working.
* Assist/educate participants in research protocols and methodologies.
* Recognise and use spontaneous and formal learning opportunities and share knowledge and experience with other staff.
* Continue to maintain and develop personal and management skills by undertaking mandatory and other training as required.
* Support research staff in the implementation and organisation of basic science and clinical trial protocols when appropriate.
Specific Requirements
ESSENTIAL
* A graduate qualification in a field or discipline relevant to the area of investigation i.e. BSc, MSc or PhD.
* (Professional degree in Nursing or equivalent).
* Bord Altranais (Nursing and Midwifery Board of Ireland) registration.
* Minimum of 5 Years post registration experience.
* Management/coordination of investigator led clinical investigations and/or clinical trials (essential).
* Experience working as part of a multi-disciplinary team in a clinical research environment.
* Excellent interpersonal and organisational skills.
* Must have the ability to work in a complementary role to medical colleagues & other members of the multidisciplinary team.
* Evidence of ongoing professional development.
* Demonstrable knowledge of good clinical practice.
* Clinical research experience/interest in clinical research.
* Ability to work independently or as part of a team.
* Excellent verbal and written communication skills.
* Able to use initiative.
* Able to prioritise and deliver agreed objectives.
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