Clinical Research AssociateLocation: Belfast / requires travel when requiredJob Purpose:Act in the role of clinical site monitor to regularly visit/remotely assess in vitro diagnostic medical device clinical study sites and ensure that the study is conducted in compliance with the study protocol, ICH GCP and local regulatory requirements.Key Responsibilities:The CRA will be involved in all aspectsof the in vitro diagnostic clinical trial, including qualification of investigational sites as well as setting up, initiating, monitoring and close-out of assigned study sites. The CRA will be required to carry out the following duties at clinical investigation sites:Completeappropriate training sessions with ProjectLeadsIdentify and assess the suitability of facilities to be used as the device study/investigation siteConduct site monitoring in accordance with the study protocol/risk-based site monitoring planLiaise with site to agree study personnel availability and visit dateProvide written confirmation of visit date and agendaPrepare and review detailed study monitoring reportsProvide detailed study data and communication trackers in timely manner (as per protocol/monitoring plan)Follow up on site and sponsor actions to close out;Present and train study protocols to research study teamsCollect all site documents for Sponsor recordsReconcile site regulatory binder with Sponsor Master FileAttend Investigator MeetingsDesign and complete SDV case report formsCoordinate with the ethics committee on study continuation and annual reportingReport to ARC Regulatory Project Lead to prioritise actions.Any other duties, within reason and capability, as determined by ARC Regulatory management.Essential Criteria:Life Sciences Degree or equivalentAt least 5 years experience in Clinical Research with minimum 3 years experience monitoring general Medical Device or IVD Medical Device clinical studiesProven experience in all aspects of clinical study site monitoring from selection and start up to close outHighly experienced in source document/data verification with a forensic ability to identify relevant issues in the integrity of study dataSignificant experience in data query and protocol deviation resolutionKnowledge of local regulations governing medical device clinical researchKnowledge of clinical data management requirementsExpert knowledge of Good Clinical Practice; ICH-GCP and ISO 14155Experience of Monitoring pivotal medical device/in vitro diagnostic medical device clinical studiesKnowledge of monitoring Essential Study DocumentsExperience in presenting and training on study Protocol, Investigators Brochure and (e)Case Report Form user acceptance testingWriting and presenting Clinical Study Monitoring Plans,Ethics Committees & Submission process knowledgeKnowledge of local Adverse and Serious Adverse Events reporting processes for medical device clinical studiesPresenting and understanding Investigator and Site responsibilitiesClear understanding of Informed Consent process and ongoing IC SDVAble to work flexibly as required to ensure business needs are metValid PassportDesirable CriteriaCurrent ICH GCP certificationPrevious oncology experienceSite pre-qualification experienceGCP and GLP AuditingUS FDA BIMO inspection readiness preparationIVD and CDx ExperienceWe are an equal opportunity employer; applications are welcome from all and appointment will be made on the basis of merit.WHJS1_NI