We have opportunities available within our clients' dedicated outsourcing division which gives clinical professionals the opportunity to work directly for the sponsor - typically a large pharmaceutical /biotechnology company. There will be a heavy investment and support in your career development.
Clinical Research Associates, based in Dublin, Ireland Permanent, Full-Time employment
We are looking for a Clinical Research Associate located in Dublin, Ireland. This position is to be client dedicated, within the outsourcing teams where you have the opportunity to work on the client /sponsor site and be 100% dedicated to one major pharmaceutical company. This is an ideally office based role for someone located in Dublin.
As CRA you will be responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits.
Site administrating and site monitoring responsibility for clinical studies according to Standard Operating Procedures, ICH Guidelines and GCP; Recruiting potential investigators, working with start-up department for EC submissions, translating study-related documentation, organizing of meetings and other tasks as instructed by supervisor; Completing Serious Adverse Event (SAE) reporting, processing production of reports; Negotiating study budgets with potential investigators and assisting the legal department with statements of agreements as assigned;
Thorough knowledge of monitoring procedures, and ICH Guidelines and GCP including a basic understanding of regulatory requirements; Minimum of 2 years of UK/Ireland clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs Good planning, organization and problem solving abilities Ability to work with minimal supervision; Good communication and interpersonal skills Good analytical and negotiation skills; Computer competency Works efficiently and effectively in a matrix environment Full driving license