15 Flexible Research jobs in Ireland

Stryker's Research & Technology Development (R&TD) Team are looking for a curious and visionary Principal Researcher and Concept Designer to explore and push the boundaries of technology and clinical innovation at Stryker's Innovation Centre in Cork, Ireland. This role blends human-centered analytical research with creative ideation to conceptualize groundbreaking solutions that address unmet clinical needs and improve patient outcomes.
R&TD focuses on early-stage, high-risk research and technology initiatives that are 5-10 years away from commercialization. You will work with our cross-functional team on early-stage projects across various business units. Your role is to carry out empathic user research, converting insights into ideation concepts with consideration for Desirability, Feasibility and Viability (DFV), ensuring a robust transfer into our New Product Development (NPD) teams.
We are looking for someone who thrives in the front-end of innovation, blending clinical needs and technology applications in compelling, human centered concepts. This role is ideal for designers who are curious and self-driven, love solving complex challenges, and want to make foundational contributions that will shape the medical devices of tomorrow.
Stryker is one of the world's leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives.
Join us to help shape what's next-before the market even knows it needs it.
This role is hybrid with the expectation to be on-site in Cork, Ireland.
WHO WE WANT
We want-
+ **User-focused creators.** Passionate creative leaders who design with the user in mind, developing medical devices that help change patients' lives and create the next generation of user experience in the OR.
+ **Curious learners.** Designers driven by deep empathy for users, and passionate about transforming ambiguity into clarity. People whoseek out cutting-edge research and information to expand and enhance their ability to design medical devices.
+ **Collaborative partners.** People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses and lead the development of best practices.
+ **Analytical problem solvers.** People who go beyond just identifying root causes but evaluate optimalsolutions and recommend comprehensive upgrades to prevent future issues.
This role is a key contributor to our cross-functional research team, collaborating with engineering & marketing to research and design digital and physical solutions for cutting-edge medical devices.
WHAT YOU WILL DO
As a member of the Research and Technology Development team, you will be at the front end of research - diving deep into user insights, emerging technologies, and clinical procedures to create concepts that enhance existing portfolios and inspire future product and system solutions.
+ **Conduct Exploratory Research**
+ Investigate emerging medical trends, technologies, and patient needs
+ Analyze data from clinical sources, academic research, and market signals
+ **Ideate & Conceptualize**
+ Translate insights into novel device concepts, services, and experiences
+ Create design mockups, storyboards, or prototypes to communicate ideas
+ **Collaborate Cross-Functionally**
+ Partner with clinicians, engineers, and product teams to step through the research process (DFV)
+ Facilitate ideation workshops and innovation sprints
+ **Develop** **& Iterate**
+ Conduct user interviews and feedback loops with healthcare professionals
+ Refine concepts based on technical constraints and user input
+ Prototype development aligned to the requirements of the DFV stage gates for successful transfer into NPD
+ **Document & Present**
+ Deliver concept decks, design documentation, and pitch materials
+ Advocate for the vision in stakeholder meetings and innovation reviews
WHAT YOU NEED
Core skills-
+ Experience with ethnographic research and design thinking methodologies
+ Knowledge of UX design for medical devices including digital health solutions
+ Strong visual and verbal communication
+ Proven skills in prototyping and manufacturing technologies
Qualifications-
+ **Bachelor's degree** in User Experience (UX) Design, User Interface (UI) Design, Interaction Design, Industrial Design, Human-Computer Interaction (HCI), or a related field. **BFA or BS** **required** .
+ **10+ years of professional experience** in UX or Interaction Design
+ Proven experience with a portfolio that showcases your design process and outcomes.
+ Proficiency in leading design and research tools including **Adobe Creative Suite,** **Rhino 3D,** **Keyshot** **,** **Figma,** **Miro** , and others.
+ Experience in the **medical device field is a strong plus** .
This role will be posted for a minimum of 3 days.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

**Minimum qualifications:**
+ Bachelor's degree or equivalent practical experience.
+ 4 years of experience with program management within design or UX organizations.
+ 4 years of experience in program or operations management, and execution of end-to-end programs.
+ Experience analyzing data to gain insights into program performance and identify improvement opportunities, including proposing and executing analytical approaches.
**Preferred qualifications:**
+ Experience with User Research, or research-focused tools and methodologies.
+ Experience with participant sourcing or user acquisition strategies.
+ Experience with marketing or outreach campaigns for user acquisition.
+ Knowledge of UX methodologies, craft, culture, and processes.
The UX Infrastructure (UXI) team empowers over 6,000 UXers across more than 50 Google product teams by providing program management and a passion for user experience. We support Googlers in building user-centric products, from finding participants and onboarding UX agencies to designing user experience spaces.
Our specific team, UXI Research Operations, is dedicated to enabling exceptional product development by eliminating barriers to gathering user insights and delighting the millions of research participants who engage with Google. We provide crucial participant recruitment support, allowing UX Researchers (UXRs) to concentrate on their core craft and develop products. Participant sourcing is fundamental to our operations, ensuring the team can deliver essential recruitment services and meet stakeholder expectations for accessing participants needed to conduct effective research and gather high-quality insights that inform product development at Google.
User experience is at the forefront of how we create intuitive, innovative, and beautiful products that people love. We strive to learn and understand our users' needs, behaviors, and emotions to gather insights that inform product strategy and design. Our UX teams include designers, researchers, content strategists, and engineers who are passionate about quality, usability, and simplicity. We work on collaborative teams to solve complex challenges and craft experiences that highlight our products' unique capabilities and personalities. Our work touches billions while exemplifying a key principle that is core to Google's philosophy: "Focus on the user and all else will follow."
**Responsibilities:**
+ Build and maintain a robust participant pipeline for UX research and drive recruitment velocity by unblocking participant access challenges experienced by UXRs and Research Coordinators.
+ Manage a prioritized participant acquisition pipeline that addresses key user needs, whilst delivering effective sourcing solutions that drive impactful database growth for key audience profiles in target countries and cities.
+ Navigate tooling transitions to ensure participant pipelines are accurately sourced and engaged.
+ Streamline and optimize current workflows for collecting profile needs and triaging sourcing requests from stakeholders.
+ Establish campaign reports to provide visibility and transparency on the performance of launched sourcing campaigns.
Google is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also and If you have a need that requires accommodation, please let us know by completing our Accommodations for Applicants form:

Be a Heart Research Hero: Clinical Research Nurse (Cardiology) Join our passionate team at the forefront of cardiovascular research! As a Clinical Research Nurse (CNM2) at the Mater Private Hospital's Cardiovascular Research Institute Dublin, you'll play a pivotal role in driving advancements in heart health. Why you'll thrive here: Make a tangible difference in the lives of cardiac patients through groundbreaking research. Collaborate with a dedicated team of researchers and clinicians in a dynamic environment. Gain valuable experience in clinical research methodologies and contribute to impactful publications. Utilise your strong clinical skills and organisational talents to ensure smooth study execution. Responsibilities: Work alongside investigators to recruit participants for clinical trials in cardiology. Manage research databases and ensure accurate data collection. Coordinate patient study visits, adhering to protocols and regulations. Educate and support patients throughout the research process. You're a great fit if you have: A minimum of 5 years' experience as a Registered General Nurse with the NMBI. At least 2 years' experience in cardiology care. Proven clinical and managerial skills with a keen interest in research. Excellent interpersonal and communication abilities to build rapport with patients and colleagues. Strong organisational skills and a meticulous attention to detail. Bonus points for: Prior experience in clinical research. Postgraduate qualifications in research or cardiology. The Mater Private Network offers: Competitive salary and benefits package. Opportunities for professional development and training. A supportive and collaborative work environment. Be part of a team making a real difference in healthcare. Ready to join us? We look forward to receiving your CV! Mater Private Network is an Equal Opportunities Employer Skills: Research Nurse Manager

We are looking for respondents across IrelandPlease register your interest at can also now download for free the CINT Opinion App on your Smart Phone. Just type "Opinion App" in the App Store and download it. You will then be able to answer PAID survey from your smart device. Please feel free to pass on the registration link to your friends and family as this is open to anyone who might be interested in market research activities

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
**Assoc Research Scientist - Biopharma**
At PPD, part of Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.
We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research, our work spans laboratory, digital and decentralized clinical trial services.
Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
We have a great opportunity for an Associate Research Scientist to join our growing Biopharmaceutical team. This role is a Technical Lead position based at our Analytical GMP facility in Athlone, Ireland.
**Location/Division Specific Information**
Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
**Discover Impactful Work:**
The role of Associate Research Scientist is responsible for the regulatory and scientific conduct of development and stability projects in the Biopharmaceutical Laboratory. Performs troubleshooting across multiple assay formats, clients and cell lines. Calculates and interprets data and records data in adherence with PPD SOPs and any additional requirements specific to the lab and/or client.
**A day in the life:**
+ Independently performs analytical testing, method optimization/validation, and/or other speciality technologies studies OR method transfers for pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems. Understands and conforms to methods, and protocols applicable to assigned tasks. Designs and completes experiments independently.
+ Reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.
+ Prepares and reviews study protocols, project status reports, final study reports and other project-related technical documents.
+ Communicates data and technical issues to clients on a weekly basis (or as needed).
+ Provides technical mentorship and training to staff.
+ Leads analytical (procedural and instrumental) troubleshooting sessions.
+ Assists in preparation and implementation of SOPs and quality systems.
+ Reviews, interprets, and analyses data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.
**Education and Experience**
+ Degree or equivalent in Chemistry or Biochemistry
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
**Knowledge, Skills, Abilities**
+ Knowledge of general chemistry, biochemistry techniques (Western Blot, total protein by BCA or micro BCA assay, ELISA, HPLC/UPLC)
+ Proven experience of method development of identity and purity assays by Western Blot.
+ Ideally experience in leading CMC studies for biopharmaceutical products including method validation
+ Proficiency on technical operating systems (including Image Lab software)
+ Proven problem solving and troubleshooting abilities
+ Ability to independently perform root cause analysis for method investigations
+ Proven ability in technical writing skills
+ Time management and project management skills
+ Good written and oral communication skills
+ Ability to work in a collaborative work environment with a team
+ Ability to train junior staff
**Work Environment**
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
+ Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
+ Able to work upright and stationary and/or standing for typical working hours.
+ Able to lift and move objects up to 25 pounds.
+ Able to work in non-traditional work environments.
+ Able to use and learn standard office equipment and technology with proficiency.
+ May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
+ Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today!** ** Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1- *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
+ This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
**_We welcome and encourage applicants from outside of Ireland. We can provide support with immigration and visa needs for successful applicants and dependents, tax consultations and other basic destination services. All other relocation costs are at the expense of the applicant._**
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Purpose of the Role Clinical research is essential to provide an evidence base for improved medicines and treatment of sick children. It is well accepted internationally that hospitals active in research and innovation are associated with better outcomes for patients and better recruitment and retention of staff. As Ireland's largest paediatric hospital and the leading centre in Ireland for the conduct of clinical trials and studies in children and young adults, CHI has placed excellence in research and innovation as one of its key strategic objectives. As part of ongoing development at CHI towards the opening of the new Children's Hospital, a rationalisation and integration of the existing clinical research infrastructure across all sites is being undertaken. Under the leadership of the CHI Director of Research & Innovation, a new Research & Innovation Office (RIO) and Clinical Research Centre (CRC) are being set-up within CHI and will bring all aspects of clinical research infrastructure together under a single governance and management structure. The Clinical Research Centre is the forerunner of the new paediatric Clinical Research Facility (CRF) that will be embedded in the new Children's Hospital. The CRC is made up of a team of research staff working across CHI sites to support clinical teams in the conduct of clinical trials and other clinical research studies that require specialist expertise and support. The Clinical Research Nurse is a key part of this team, working to support Investigators and research teams with clinical research activities. They will act as the primary advocate for the patient, both prior to and throughout their participation in a research study or clinical trial. As part of a team of Research Nurses, they will work closely with the CRC Operations Manager, Project Managers, Research Nurses and Research Coordinators, ensuring that study activities are carried out effectively and in compliance with Good Clinical Practice (GCP) standards. They will have particular focus on assisting the Principal Investigator to enrol patients to studies and clinical trials and schedule and conduct study visits, ensuring patient safety throughout and maintaining the Investigator Site File. Throughout the research study lifecycle, this role will provide continuity back-up and support as required to other Clinical Research Nurses and Coordinators to ensure the smooth running of research activities from set-up through to closeout, across the portfolio. This is an exciting opportunity to work within a highly motivated team and a dynamic environment, and to be involved in bringing advancements in health outcomes for children and young adults in Ireland. The role offers opportunities for ongoing professional development and the successful candidate will be provided with training and mentoring specific to their role. Essential Criteria: Be registered in the Children's division of the active register of Nurses & Midwives maintained by the Nursing and Midwifery Board of Ireland (Bord Altranais agus Cnimhseachais na hireann) OR Be registered in the General Division of the active register held by NMBI and have relevant children's nursing experience AND At least 3 years post registration experience or equivalent relevant experience. Have the clinical, managerial and administrative capacity to properly discharge the functions of the role Demonstrate evidence of continuing professional development at the appropriate level To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.

Purpose of the Role The purpose of this role is to be responsible for the development and evaluation of a research programme to examine the needs for a psychology service for children with neuro-muscular conditions at CHI (examples of conditions include Duchenne muscular dystrophy, Becker Muscular dystrophy, Spinal muscular atrophy among others). This will involve the delivery of high quality patient and family-centred psychological assessment and therapeutic services in a paediatric specialty and to fully and competently discharge the duties of the post. The post-holder will work closely with the core research team including Principal Investigator (PI) Professor Denise Mc Donald, PhD research student employed for this project, the senior and staff grade psychologists working on the project. The project will run for three years and is funded to develop, implement and evaluate paediatric psychology care for children and young people with neuromuscular conditions and their families attending CHI Tertiary clinics. Essential Criteria: Candidates must: have a recognised honours degree in psychology have a recognised postgraduate professional qualification in Psychology recognised by the Psychological Society of Ireland - such as clinical, counselling or educational psychology. have a minimum of eight years postgraduate professional experience in psychology (inclusive of time spent in training), at least three of which are at senior grade have relevant training and experience in psychological assessment and intervention skills for patients with a wide range of psychological difficulties inclusive of developmental/neurodisability presentations and or physical impairment. demonstrate competence in clinical audit, research and supervision skills possess the requisite knowledge and ability (to include a high standard of suitability and management ability) for proper discharge of the duties of the post Candidates who have completed their postgraduate training outside of Ireland must ensure that their qualification is validated by the Department of Health and Children How to Apply & Informal Enquiries Applications for this post must be accompanied by a cover letter, setting out relevant experience that illustrates how the essential criteria listed above is met. The criterion for short listing is based on the requirements of the post, as outlined in the eligibility criteria. * Please note that you must submit a cover letter with your CV, this forms part of your application and CV's will not be accepted without a detailed cover letter. The closing date for submissions of CV's and cover letter is by 2nd of September by 23:45pm. Applications must be completed through the advertised post on by clicking 'Apply for Job'. Applications will not be accepted through direct email or any other method. For informal enquiries for this specialty/department, please contact Dr Anne Kehoe, Psychology Manager Tallaght at anne.keho or Helena Rushe, Director of Psychology at Helena.Rush or Professor Denise Mc Donald, Consultant Paediatrician Neurodisability CHI / Associate academic Professor TCD ( ) For other queries relating to this recruitment process, please contact Talent Acquisition specialist PLEASE NOTE: CHI has transitioned to a process of a one commencement day per month for all new employees, CHI internal transfers and Secondments. This update to our Onboarding process is aligned to changes in our monthly/fortnightly payroll and with the launch of our new corporate induction program. This process enhancement ensures that we can thoroughly prepare for your arrival and facilitate a smooth transition in your onboarding journey. So that the Onboarding team can confirm your start date, you will need to ensure that your mandatory training is completed at least 7 days prior to your commencement date. It is important for you to note that if you do not have your pre-employments and mandatory training completed in time, your commencement date will be deferred to the next available date. Below, you'll find the list of commencement dates for 2025. September 15th October 13th November 10th December 15 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.

Purpose of the Role The purpose of this role is to be responsible for the delivery of a research programme to examine the needs for a psychology service for children with neuro-muscular conditions at CHI (examples of conditions include Duchenne muscular dystrophy, Becker Muscular dystrophy, Spinal muscular atrophy among others). This will involve the delivery of high quality patient and family-centred psychological assessment and therapeutic services in a paediatric specialty and to fully and competently discharge the duties of the post. The post-holder will work closely with, and report research strategy and output, to the Principal Investigator Professor Denise Mc Donald, the Principal Specialist Psychologist, the Staff Grade Psychologist and the PhD Research student employed for this project The post-holder is part of a 3 year research project where the aim is to develop, implement and evaluate paediatric psychology care for children and young people with neuromuscular conditions and their families attending CHI Tertiary clinics. Essential Criteria: Hold a recognised University degree or diploma obtained with first or second class honours in which psychology was taken as a major subject and honours obtained in that subject or hold a recognised qualification equivalent to above And Hold a relevant post-graduate professional qualification in Psychology recognised by the Psychological Society of Ireland. Or Hold a postgraduate professional psychology qualification validated by the Department of Health and Children. Applicants should refer to the Dept. of Health & Children regulations on the Employment of Psychologists in the Health Services, as well as, the PSI Guidelines on Post Graduate Training & Qualifications. Be eligible for Senior Grade i.e. has a minimum of two whole years' experience working at Staff Grade level, following completion of post graduate professional training. Experience of psychological assessment and treatment of children, adolescents and their families with a range of psychological needs of a complex nature How to Apply & Informal Enquiries Applications for this post must be accompanied by a cover letter, setting out relevant experience that illustrates how the essential criteria listed above are met. The criterion for short listing is based on the requirements of the post, as outlined in the eligibility criteria. * Please note that you must submit a cover letter with your CV, this forms part of your application and CV's will not be accepted without a detailed cover letter. The closing date for submissions of CV's and cover letter is the 2nd of September 2025 by 23:45pm. Applications must be completed through the advertised post on by clicking 'Apply for Job'. Applications will not be accepted through direct email or any other method. For informal enquiries in relation to these posts, please contact: Dr Helena Rushe, Director of Psychology , Dr Anne Kehoe, Principal Psychology Manager (), Professor Denise Mc Donald, Consultant Paediatrician in Neurodisability CHI / Associate Academic Professor TCD ( ) For other queries relating to this recruitment process, please contact Talent Aquisition Specialist PLEASE NOTE: CHI has transitioned to a process of a one commencement day per month for all new employees, CHI internal transfers and Secondments. This update to our Onboarding process is aligned to changes in our monthly/fortnightly payroll and with the launch of our new corporate induction program. This process enhancement ensures that we can thoroughly prepare for your arrival and facilitate a smooth transition in your onboarding journey. So that the Onboarding team can confirm your start date, you will need to ensure that your mandatory training is completed at least 7 days prior to your commencement date. It is important for you to note that if you do not have your pre-employments and mandatory training completed in time, your commencement date will be deferred to the next available date. Below, you'll find the list of commencement dates for 2025. October 13th November 10th December 15th To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.

Organisation/Company University College Cork Department HR Research Research Field Medical sciences " Other Researcher Profile Leading Researcher (R4) Positions Other Positions Country Ireland Application Deadline 8 Sep 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

INFANT is now accepting applications for a Senior Research Coordinator - Quality Officer. The Quality Officer will work with the INFANT Quality and Regulatory Manager, PIs, clinical staff, study teams, in4kids Clinical Trials Network, sponsors, and other stakeholders, on quality and regulatory affairs issues pertaining to maternal and child health research studies.

INFANT leads the HRB Irish Network for Children's Clinical Trials (in4kids) that supports researchers in Ireland to deliver high-quality clinical trials to improve children's health.

The Quality Officer will be responsible for all research projects monitoring visits and generation of detailed reports ensuring a high standard of quality across all studies at INFANT and across the in4kids clinical trials network. They will provide quality control applications both regulated and observational studies to Research Ethics Committees and Regulatory Authorities. They will chair and conduct clinical trial meetings monthly and liaise with PIs and project managers on study related issues and ethics committees and regulatory authority queries. The Quality Officer will be involved in the training of all INFANT personnel in Good Clinical Practice and in new staff induction and maintenance of relevant personnel training records. As a member of the Operations Team, the Quality Officer will report on personnel training and designated training activities implemented within the Centre.

The Quality Officer will also assist the QRAM in maintaining and updating INFANT QMS as required.

The Senior Research Coordinator - Quality Officer will work closely with the Quality & Regulatory Manager and the wider operational team to ensure all operational, administrative, and compliance functions within INFANT are being properly executed in accordance to best practices. This will include the following duties:

• Manage own workload, liaising with INFANT Quality & Regulatory Manager to ensure all projects have been quality controlled and any queries followed up and resolved.
• Coordinate and chair monthly clinical study meetings with all relevant personnel and maintain a tracker of the studies and any updates
• Ensure safety reporting for all studies is performed and the appropriate documentation is completed and events reported to Principal Investigator, Ethics Committee and relevant authorities if required.
• Participate in Health & Safety Audit and corrective action implementation as indicated in the Audit Report. Member of INFANT H&S Team
• Participate in teaching programmes and training for INFANT personnel especially any updates to Good Clinical Practice Guideline.
• Assist/educate new personnel in generation of research protocols and any study related documentation as required
• Complete and attend any relevant courses that will enhance knowledge and maintain current best practices in research
• Generate new Standard Operating Procedures if required encompassing INFANT ISO Accredited QMS.
• Assist INFANT QRAM in completing internal audit of QMS and generation of audit findings and corrective actions
• Have oversight of INFANT QMS and all relevant documentation and processes.
• Awareness of any Opportunities for Improvement and implementation of appropriate documentation as required.
• Constant horizon scanning ensuring INFANT policies and procedures are current and best practice
• Liaise and interact with UCC Clinical Research Reporting Officer (CRRO) and UCC Data Protection Officer (DPO) for all UCC sponsored clinical research as required

Quality: Trial Monitoring

• Develop monitoring plans in collaboration with QRAM, and project managers.
• Conduct onsite and remote monitoring for a variety of clinical trials including clinical trials of Investigational Medicinal Products (CTIMP), clinical investigations of medical devices, other interventional trials and observational studies in Ireland and Europe.
• Monitor sites / studies to ensure compliance with the protocol, standard operating procedures, ICH-Good Clinical Practice and relevant EU and Irish legislation. Conduct Source document verification (SDV), verify validity of Patient Informed Consent Forms, and review Investigator Site File and drug / device accountability records at study sites.
• Prepare comprehensive monitoring reports and follow up letters to study sites.
• Capture protocol violations and implement CAPAs, provide relevant training to site personnel.
• Management of IMP at the centre involving liaising with research pharmacists and maintaining all documentation from IMP receipt to destruction as required
• Liaise with the QRAM, PIs, Study Teams, Clinical Staff, in4kids Network, Sponsors and other stakeholders on quality and regulatory affairs issues.

Regulatory Affairs

• Quality control (QC) initial applications and amendments to Research Ethics Committees (REC) in Ireland and in EU (If applicable) for Clinical trials, and clinical investigations.
• Quality control clinical trial and clinical investigation applications and amendments to regulatory authorities (RA) including HPRA (Ireland), MHRA (UK) and other regulatory authorities in Europe as required.
• Liaise with relevant Project Manager (PM) on REC & RA queries and responses if required.
• QC of annual updates/progress reports to REC and RAs as required.
• QC end of trial notifications to REC and RAs.
• Access and familiarisation with CTIS system and completion of CTIS applications and study amendments as required.

Specific Requirements

• A PhD or postgraduate qualification in a relevant field or discipline.
• At least 5+ years' experience in Clinical Quality involving both observational and regulated research
• Knowledge and understanding of ICH-GCP R3 and the relevant Irish and EU legislation governing Clinical Trials and Clinical Investigations - CTR and MDR.
• Excellent report writing and presentation skills
• Demonstrable knowledge of good clinical practice ICH GCP E6 R3.
• Access to CTIS and ability to navigate the portal
• Working knowledge of clinical research electronic data capture systems
• Excellent communication and interpersonal skills in order to communicate effectively with staff, students and stakeholders.
• Ability to develop good working relationships.
• Experience of working in a multidisciplinary research team environment and working with people from a wide range of cultures.
• Capacity to manage and prioritise a high workload, with a track record of delivering results under pressure and on time.
• Working knowledge of ISO 9001:2015 and relevant documentation
• Evidence of ongoing professional development