ORGANISATION/COMPANYNational University of Ireland, Galway
RESEARCH FIELDMedical sciences › Medicine
RESEARCHER PROFILERecognised Researcher (R2)Established Researcher (R3)
APPLICATION DEADLINE27/04/2021 17:00 - Europe/London
LOCATIONIreland › Galway
TYPE OF CONTRACTTemporary
HOURS PER WEEK39
OFFER STARTING DATE31/05/2021
Applications are invited from suitably qualified candidates for a full time fixed-term position as a Research Associate in Advanced Therapies and Cancer research group at the HRB Clinical Research Facility at the National University of Ireland, Galway. The position is available immediately for eight months with the option of extension.
The HRB Clinical Research Facility, Galway’s (CRFG) remit is to increase the amount of clinical research currently happening in Ireland. Researchers and clinicians will work with other scientists to improve our understanding of a variety of diseases and to develop new tests and treatments to help tackle these diseases. The Centre aims to provide patients with the latest advances in areas such as Cancer and Cell Therapy
The successful candidate will be part of a multi-disciplinary team engaged with researchers and clinicians to support cell therapies and cancer clinical research activities.
The successful individual will be expected to arrange study visits and interact with patients and healthy volunteers participating in Cancer/ Haematology and Cell Therapy clinical research projects. Within the remit of this post, the individual will arrange and conduct research procedures as delegated by the investigator and in compliance with clinical trial regulations. The individual will gather and enter research data in compliance with GCP and data protection legislation, lead in internal audit, educational initiatives, training and oversight of junior team members. It is expected the successful individual will undertake independent research, contribute to scientific publications and attend relevant national and international meetings when applicable. The Clinical Research Associate will support the ongoing development of the ATC team and the CRFG
MAIN DUTIES AND RESPONSIBILITIES:
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 Affairs Manager.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, study recruitment, enrolment, 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 and participate in 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
If the role requires, they shall lead in the development of a training program for data entry staff within CRFG and lead in the orientation and training of new data entry staff within the CRFG.
Provide direction and guidance and supervision to new and or junior members of staff and students as informed by your line manager.
If required lead in the development of a training program for data entry staff within the ATC and lead in the orientation and training of new data entry and/or research staff within the Advanced Therapies and Cancer Research Group
Perform other duties as assigned by line manager and directors of the Advanced Therapies and Cancer Research Group CRFG
Bachelor's degree or higher in a medical, clinical, scientific or related field from an accredited institution
A minimum of one year working in the area of Cancer Clinical Research and/or Cell Therapy Clinical Research
A minimum of 4 years’ clinical research experience post primary degree
Knowledge of clinical research regulations and skill in performing internal audit.
Certification in ICH-GCP
Strong Project Management and organisational skills, ability to manage multiple tasks and meticulous attention to detail in a high volume, deadline controlled environment.
Fluent in English possess excellent written and verbal communication and interpersonal skills
Strong software and computer skills, including MS Office applications
Experience in the field of clinical or translational research and/or other academic studies
Proven leadership and management skills
Strong computer skills, including MS Office applications
Salary: €38,631 – €50,031 per annum pro rata for shorter and/or part-time (public sector pay policy rules pertaining to new entrants will apply).
Start date: Position is available from earliest agreed start date June 2021
Continuing Professional Development/Training:
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 Clinical Research Facility is available at www.crfg.ie
NB: Gárda vetting is a requirement for this post
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 email@example.com
Please put reference number NUIG RES 073-21 subject line of e-mail application.
Closing date for receipt of applications is 5.00pm on 27th April 2021
Interviews are planned to be held on 7th May 2021
A panel may be formed for future similiar posts in other therapeutic areas such as Obstetrics, Gynaecology, Diabetes, Inflammatory Diseases, Critical Illness, Cystic Fibrosis, Cardiovascular Disease, Psychiatry, Gastroenterology and Renal Disease.
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.
All positions are recruited in line with Open, Transparent, Merit (OTM) and Competency based recruitment
National University of Ireland, Galway is an equal opportunities employer.
EURAXESS offer ID: 627186
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