Clinical Research Associate, HRB Clinical Research Facility, NUI Galway (NUIG RES 137-21)

 

Applications are invited from suitably qualified candidates for a full time fixed-term position as a Clinical Research Associate at the HRB Clinical Research Facility at the National University of Ireland, Galway. The position is available immediately to 31st December 2022, with potential to extend subject to project success and further funding acquisition.

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 successful candidate will be part of a multi-disciplinary team engaged with researchers and clinicians to support clinical research activities.

The purpose of this role is to verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents. The CRA will be working within a highly qualified team to identify, select, initiate and close-out investigational sites for clinical studies in the HRB Clinical Research Facility Galway (CRFG)). They will make sure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), ensuring adherence to applicable regulations, standards and the principles of International Conference on Harmonisation, Good Clinical Practice (ICH-GCP).

Duties:

• Coordinate all necessary activities required for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation.
• Perform study procedures as required by the protocol and other study duties as delegated to them.
• Verifying that source data/documents and other trial records are accurate, complete, and are maintained according to GCP principles.
• Administer protocol, and other study related training, and establish regular lines of communication to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices relative to the protocol, applicable regulations. Escalate quality issues to the Quality and Regulatory Manager.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, study recruitment, enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and other required study documentation.
• Assist the team with tasks, provide back-up to the operations team, assist in generation of status reports, providing project metrics, drafting project instructions/guidelines and assist in implementation of new processes.
• Liaise with different functional team members, e.g. project management, pharmacovigilance, data management, health care professionals e.g. investigators, site coordinators and designees to address project related issues.
• Undertake periodic internal quality assurance audits as part of the multidisciplinary team
• Facilitate monitoring visits by external audits by Regulatory Bodies and/or sponsoring Pharmaceutical Companies
• Maintain the storage of patient records in accordance with institutional policy
• Compiling reports and updates on clinical research trial activity
• Perform other duties as assigned by other members of the CRFG

Qualifications/Skills required:

Essential Requirements:

• A post graduate qualification in a clinical or life sciences related subject or equivalent
• Have at least four years’ experience in clinical research activities.
• Excellent working knowledge of Good Clinical Practice as outlined per ICH GCP E6 (R2) and ISO14155.
• Strong organizational and project management skills to ensure timeline for key project milestones are adhered to.
• Excellent verbal and written communication/presentation skills.

Desirable Requirements:

• Experience in the field of clinical or translational research and/or other academic studies
• Proven leadership and management skills

Salary: €38,632.00 to €42,200.00 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

Further information on research and working at NUI Galway is available on Research at NUI Galway Researchers at NUI Galway are encouraged to avail of a range of training and development opportunities designed to support their personal career development plans. NUI 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.nuigalway.ie/rdc for further information.

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

Further information about HRB CRFG is available at crfg.ie

NB: Gárda vetting is a requirement for this post (as appropriate to Child Protection Policy)

To Apply:

Applicants should send a covering letter, detailed CV and the names and addresses of at least three referees via e-mail (in Word or PDF format only) to: crfg@nuigalway.ie

Applicants must put Ref. No. NUIG RES 137-21 in subject line of e-mail application

Closing date for receipt of applications is 5.00 pm Thursday 22nd July 2021

Due to the University closure related to COVID-19, interviews may have to take place virtually and start dates may need to be delayed 

NUI Galway reserve the right to readvertise or extend the closing date for this post.

National University of Ireland, Galway is an equal opportunities employer.

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