Oxford Global Resources O

Site Regulatory Submissions/Clinical Site LeadNew (BB-CBE2E)

Trouvé dans: Xpatjobs BE

Are you an experienced CRA with thorough knowledge of regulatory processes ? You are fluently trilingual and up for a new challenge in a dynamic environment ? You like to be pro-active, take initiative and move forward ? This opportunity may be what you are looking for ! Job description Support regulatory activities at study start up in Belgium and Nordics Countries. Focus is preparation of documents for submission to ethics committees (EC) and competent Authorities (CA), especially country and site-specific Patient Informed consent adaptation; obtain documents required for submission and support the process until vote or approval is granted. EC/CA communication in close collaborate with CSL/CRA/Project Manager. Drive study execution and operational excellence across Client Cardiovascular therapies (Vascular, Cardiac Rhythm Management, EP, Structural Heart, and Heart Failure). This includes nomination, qualification, start-up processes, enrollment, compliance to protocol and data entry and on-site monitoring. ResponsibilitiesSubmission of studies to the Ethics Committees and Competent Authorities for Belgium and Nordics, covering the following tasks (not limited to) Prepare documents for Ethics Committee/Competent Authority (EC/CA) submission in the assigned region.Initiate translation of documents as applicable (e.g. Patient Informed Consent); review and adapt translations to appropriate verbiage.Prepare Country/Site Specific Patient Informed Consent form according to Regulatory and EC requirements and obtain internal approval where applicable.Interpret clinical study protocols in order to support EC/CA submission where layman terms are requiredPoint of contact of EC /CAPerform the submissions to EC/CASupport approval process (adaption of documents according to EC/CA requirements; responses .)Support budget adoption to country and site requirements.Prepare submission to any other authority when applicableMaintain local regulatory documents on paper or electronically as applicable and ensure upload to data management system (DMS) were applicable.Provide support to CSL / Clinical Project TeamsAssists in the development and review of informed consent document/patient information sheet to ensure all required elements are included.Assist with collection of site activation documents.Function as Clinical Site Lead for Belgium. This means being the assigned contact person for the site for all Client studies running at this site, including the following tasks (but not limited to): Manage all aspects of studylifecycle to include site regulatory and quality: Start UpNominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution.Facilitate all aspects of the start-up process and site initiation visitsUnderstand regulatory and legal requirements for study participation at a level that allows for appropriate collaboration with Client clinical staff, e.g. Site CRA, Site Contract Associate.Train facility staff regarding protocol requirements and technology.Enrollment Develop site-specific strategies to promote appropriate patient enrollment.Identify site successes and challenges and assist in implementing techniques that promote study goal achievement.Continuously evaluate site study performance and provide timely feedback to site.Regulatory and Quality Develop site-specific strategies to avoid deviations.Educate site on tools to facilitate compliance.Provide timely feedback to the sites on key compliance indicators.Escalate non-compliant sites according to corporate policy.Collect essential documents, identify and obtain missing data, data corrections, reviewing adverse events and protocol deviations.Complete all monitoring activities for the assigned sites Conduct Site Initiation Visits, Periodic Monitoring Visits and Close Out Visits per study specific Monitoring PlanReview data and source documentation from investigational sites for accuracy and completenessFacilitate resolution of data queries and action items at clinical sitesPromptly reports the findings of monitoring visits according to Client processes.Maintain accurate, detailed and complete records of monitoring visits.Do the above responsibilities fit you like a glove? Upload your CV and motivation letter via the "apply now" button and you can expect feedback from us soon. If something is not entirely clear, you can reach out to us by telephone of course. ProfileExperience with clinical regulatoryBachelor''s Degree in engineering, science, health science, nursing, or a related field, OR equivalent or related experience in cardiology or clinical research.Proficient in operating a personal computer and in using various PC-based software packages including Microsoft Word, Excel, or similar word processing/spreadsheet software.Experience with Databases is desired.French or Dutch - Native Speaker; The ability to read, write, and communicate effectively in French and Dutch is required; this requirement

calendar_todayil y a 6 jours


location_on Brussels , Brussels, Belgique

work Oxford Global Resources

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