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Quality and Reg Affairs Research Fellow
€55,000 - €60,000
21 Dec 2020
Quality & Regulatory Affairs – Research Fellow
Exciting, challenging, and rare opportunity for a Quality & Regulatory Affairs – Research Fellow
. Our client is looking to recruit for a motivated, collaborative, and detail-oriented research fellow. Bachelor’s degree in Life Science, five years’ experience in quality assurance, risk management, audit and/or regulatory inspection of clinical trials are mandatory for this role. This will also be ideally accompanied by a post graduate qualification in clinical research or research nursing.
Maintain systems to ensure that clinical trials and clinical investigations carried out within the CRF are conducted in accordance with ICH GCP guidelines, National and European legislation and any other applicable guidelines
Maintain systems to ensure compliance of CRF pharmacy services and clean room with regulatory requirements.
Maintain compliance of the CRF and associated clinical research with data protection legislation, including the Data Protection Acts and Health research Regulations
Develop regulatory strategies that feed into project timelines and will assist in the development of submission documentation
Liaise with the competent authorities such as the HPRA in relation to specific clinical trials
Develop an annual audit programme and conduct regular audits to ensure that staff, facilities, services and ongoing research comply with ICH-GCP, National and European legislation, SOPs and any other applicable guidelines
Lead the preparation for mandatory inspection of the CRF by the HPRA or other competent authority, developing and maintaining an inspection readiness plan, and accommodating and preparing for any sponsor audits as required.
Review any inspection and/or audit findings, taking responsibility for coordinating remedial action, ensuring completion of tasks and attainment of requisite regulatory standards.
Assess the education and training needs of research personnel in order to identify knowledge deficits and ensure personnel are trained appropriately.
Conduct literature- and legislative-based searches as required to inform the processes and procedures of the National Office.
Provide professional advice relating to the regulation, management and conduct of clinical research.
Liaise with ethics committees to ensure that studies meet ethical standards
Maintain accurate and timely content on the National Office webpage including publicly available registry of considered applications;
Provide information and data on the collective of National Office activities for key stakeholders as requested including the Department of Health
Liaise with other bodies involved in the regulation of health research as required
Bachelor’s degree in a life science discipline
A minimum of 5 years’ experience in quality assurance, risk management, audit and/or regulatory inspection of clinical trials
Post graduate qualification in clinical research or research nursing or commitment to undertake a relevant course within an agreed timeframe.
Knowledge and Experience:
Knowledge of ICH GCP and of relevant national and international clinical trial regulations
Experience in ICH GCP training
Experience within a commercial/academic clinical research environment
Clinical trial monitoring and/or auditing experience
Experience in developing quality strategies
Excellent communication skills (oral, written & presentation) with proven ability to work effectively as part of a team.
Strong leadership and communication skills
Self-motivated and able to work independently, showing initiative and good judgment.
Familiarity with HPRA and sponsor audits