Applications are invited from suitably qualified candidates for a full-time fixed term position as a Research Associate/Clinical Trial Coordinator with the HRB Clinical Research Facility at the University of Galway.  This post is funded with support from a variety of sources and is available to end July 2024 initially, with potential to extend subject to research funding availability.

The HRB Clinical Research Facility, Galway’s (CRFG) remit is to contribute to the development, coordination and service delivery of clinical research in Ireland and the support of emerging academic investigators. Multidisciplinary teams work in a coordinated fashion to improve our understanding of a variety of diseases and to develop new strategies to help tackle these challenges. The Centre provides patients with the latest advances in areas such as psychiatry, cancer, obstetrics and gynaecology, diabetes, inflammatory diseases, critical illness, cystic fibrosis and cardiovascular disease amongst others. We provide supporting services in quality and regulatory oversight, data management, study design and roles associated with the legal sponsorship of regulated clinical trials.

Job Description:

The coordinator works under the direction of the CRFG Director, Programme Manager and/or the Chief Investigator to co-ordinate studies for regulated (academic or commercially sponsored) clinical trial(s) and/or clinical investigation(s) and/or for non-regulated studies in the HRB-CRFG. The role is part of a multi-disciplinary team within the CRFG co-ordination unit.

This is primarily a project management role and the post holder has a pivotal role leading the coordination of research studies, clinical trial(s) or clinical investigation(s) throughout the study lifecycle of set-up, execution, close-out and reporting.

The coordinator is responsible for overseeing the daily conduct of the trial(s)/investigation(s). The role will involve the generation of key study documentation, management of resources, scheduling activities, reporting and training of study personnel in accordance with Good Clinical Practice (GCP). S/He will be the main point of contact for all study stakeholders and provide updates to associated chief/principal investigators, funding bodies and study sponsor, as appropriate.

The role will also involve contribution to the development and setup of appropriate clinical trial coordination processes, documents, SOPs and associated templates to guide the successful and standardised execution and delivery of clinical trials in the CRFG co-ordination unit.

In parallel, the post-holder may be assigned clinical trial monitoring activities, contributing to the delivery of the GCP required monitoring function in the CRFG.

The post holder may also be required to participate in co-ordination activities at the site or within the co-ordination team for non-regulated trials (e.g. recruitment) as required to support the activities underway in the CRFG.

Duties:

• Conduct clinical research work to a high standard in accordance with applicable clinical research regulations and protocols under the direction of the CRFG Director, Programme Manager and/or the Chief Investigator.
• Contribution to the development and setup of appropriate clinical trial co-ordination processes, SOPs and associated templates to guide the successful and standardised execution and delivery of clinical trials in the CRFG co-ordination unit.
• Oversee and ensure key study milestones and objectives are tracking to an agreed timeline and adhere to project management best practices.
• Develop and execute study plans including establishing a project plan, risk assessment and management and planning resources.
• Confirm the necessary processes are in place for the investigational product or medical device, as applicable and other study supplies.
• Ensure budget agreements and contracts are in place and roles and responsibilities for all stakeholders are documented prior to commencing study activities.
• Participate in process of protocol development.
• Participate in the process of study monitoring plan development as required.
• Participate in process of developing other study related documentation such as CRFs, SOPs, information sheets, risk assessments, their amendments and associated quality assurance processes and documents as required for the studies assigned.
• Ensure compliance with all applicable regulations and guidelines, CRFG coordination level SOPs and/or CRFG site SOPs as required.
• Overall responsibility for management of essential documents and the Trial Master File.
• Complete Regulatory and Ethics Committee submissions, as applicable.
• Prepare study reports as required.
• Manage the study deviation process and liaise with sites and sponsor where required on the documentation, tracking and resolution of study deviations and associated corrective/preventive actions as required for the studies assigned.
• Participate or lead the process, when required, to identify vendors/suppliers or service providers, any required vendor/service provider assessment, and any associated computer system validation requirements for systems supporting the execution of the study.
• Evaluate and document investigator and site selection.
• Oversee the process of study initiations, site training, monitoring and close-out as required.
• Liaise directly with clinical sites as required to aid resolution of queries that arise and provide direction on implementation and management of the study protocol and procedures.
• Manage and oversee the study risk assessment/risk management process for the study as required for the studies assigned.
• Manage monitoring report/letter responses on behalf of sponsor for any queries/issues that arise during monitoring as required for the studies assigned.
• Contribute to preparation for audits and inspections as required and present work as required during audits and inspections.
• Co-ordinate and undertake research study-specific processes according to specific study protocols and regulations.
• Provide training, as appropriate on study-related activities and processes for site personnel.
• Provide training as required for new personnel undertaking co-ordination tasks.
• Update sponsor, Chief Investigator, data and safety monitoring committees, regulatory bodies, ethics committees, and other governing bodies on the status of all clinical trial activities, as required.
• Provide support and backup as necessary for colleagues in coordination activities for other clinical studies forming part of the CRFG research portfolio.
• Implement strategies, support and lead as required, initiatives for participant recruitment for research studies as required.
• Undertake clinical data compilation and literature reviews for the research area and participate in dissemination of same at international meetings.
• Undertake research on, and analysis of, study outputs and measures with the aim of providing information for future funding proposals and applications.
• Determine appropriate methodologies and activities for relevant research studies in the CRFG whilst keeping up to date with research related methods and techniques.
• Contribution to manuscripts for publication to peer reviewed internationally recognised journals. Contribute to the dissemination of knowledge in the CRFG and facilitate research activities such as workshops and screening events.
• In parallel, additional duties for this role may be to undertake monitoring activities. This will be as assigned for a select number of studies in the CRFG to ensure patient safety, data integrity and GCP compliance.
• Continue to build personal skills by taking training opportunities as available and required.
• Carry out other appropriate and relevant duties under the direction of the CRFG Director, Programme Manager and/or Chief investigator.

Clinical trial monitoring responsibilities (if assigned)

• Ensure applicable sponsors, Principal Investigators and study teams adhere to the clinical trial protocol/clinical investigation plan, current regulations, applicable ICH/GCP guidelines, local policies and SOPs as required.
• Comply with all applicable regulations and guideline, sponsor SOPs and/or site SOPs as required, in the execution of the role.
• Represent internal and external research study stakeholders, in the provision of a monitoring service for the HRB-CRFG.
• Participate as part of the study management team during the trial set up phase and support the study risk assessment/risk management process and other activities required during trial set up.
• Undertake site initiation visits (SIVs) and additional site training, including protocol training, if required for relevant studies.
• Adhere to monitoring plans and required critical monitoring activities with thorough and complete documentation of the process throughout.
• Monitor clinical study progress (recruitment targets, safety reporting review, resources, etc.) through a combination of data review and on-site monitoring visits.
• Undertake source data verification/review to verify that trial data is consistent with patient clinical notes and other source documentation, applying the principles of ALCOAC.
• Meet expected timelines for completion of monitoring activities and submission of written monitoring reports.

Qualifications/Skills Required:

Essential:

• Post graduate Degree in a clinical or life sciences related subject.
• Working knowledge of Good Clinical Practice as outlined per ICH GCP and/or ISO14155.
• Strong organisational and project management skills to ensure timeline for key project milestones are adhered to.
• Excellent verbal and written communication/presentation skills.

• 4 years relevant experience, with at least 1 year of previous experience working in clinical research or a closely related field e.g. Pharma or Medical Device sector

Desirable:

• PhD in a clinical or life sciences related subject
• A Project management qualification.
• Previous experience gained in a clinical trial co-ordination role working on the co-ordination of regulated clinical trials/investigations or non-regulated clinical studies or experience in project managing a cross functional project team.
• Experience working within a Quality Management adhering to QC and QA control systems and risk management processes.
• Experience adhering to applicable regulations, guidelines and legislation for Clinical Trials.
• Experience in the identification, assessment and management of risk.
• Experience with research data collation, management and GCP monitoring.
• Self-motivated, high level of initiative and excellent attention to detail.
• Able to work both independently and as part of a team.

Salary: €41,209- €47,477 per annum pro rata for shorter and/or part-time contracts (public sector pay policy rules pertaining to new entrants will apply)

Start date: Position is available immediately

Continuing Professional Development/Training:

Further information on research and working at  Galway is available on Research at University of Galway Researchers at University of Galway are encouraged to avail of a range of training and development opportunities designed to support their personal career development plans. University of Galway provides continuing professional development supports for all researchers seeking to build their own career pathways either within or beyond academia.  Researchers are encouraged to engage with our Researcher Development Centre (RDC) upon commencing employment – see www.universityofgalway.ie/rdc for further information.

For information on moving to Ireland please see www.euraxess.ie

Further information about HRB Clinical Research Facility is available at https://www.universityofgalway.ie/hrbcrfg/

NB: Gárda vetting is a requirement for this post

To Apply:

Applications to include a covering letter, CV, and the contact details of three referees should be sent, via e-mail (in word or PDF only) to crfg@nuigalway.ie

Please put reference number University of Galway 334-22 in subject line of e-mail application.

We reserve the right to re-advertise or extend the closing date for this post.

A panel of successful applicants may be formed for future similar posts.

University of Galway is an equal opportunities employer.

All positions are recruited in line with Open, Transparent, Merit (OTM) and Competency based recruitment