Alimentiv

Sr. Clinical Research Associate (Belgium)

Posted: 1 days ago

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Job Description

Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.  In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices.  In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.Monitoring - Subject Expert Act as subject matter expert, mentor, coach and/or provide performance feedback to manager for peersAssist with selection, hiring, training, and supervision of CRAs as needed. Perform co-monitoring and training visits with CRAs. When required, act as the first escalation point for the resolution of site/patient issues or to address Sponsor concernsMay represent Director, Monitoring and Site Management or Manager, Clinical Site Management in BD initiatives with a site monitoring focusProject Monitoring LeadMay be assigned Lead CRA role and manage monitoring services for a group of projects and/or CRAs on large/complex project(s) including directing/guiding day to day activities and review/approval of monitoring reportsFunction as liaison between CRAs and other functional teams, escalating concerns and issues to management as neededParticipate and/or present at study team, kickoff and investigator meetings and act as primary contact to sponsors for all monitoring related issuesSite Recruitment and Setup Identify and recruit site investigators, coordinate the movement and delivery of trial materials, samples, tests and forms, including investigational product, protocols, SOPs, CRFs, project documents, forms and support toolsEnsure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteriaInvestigational Site Monitoring Primary clinical site contactMay act as primary contact for any questions or issues that arise from investigational sitesOversee overall integrity of the study to promote positive working relationships with the site and staffFacilitate and support site staff with access to study systems and ensure sites are compliant with project specific training requirementsEnsure all site related issues are followed until resolutionCoordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project lifecycleQualifications The successful candidate will possess a minimum of a college diploma/degree and 4-6 years of related experience. Self-motivation with strong communication skills and a commitment to achieving positive results.  Strong attention to detail and keenness to understand the importance of building collaborative relationships to achieve results.  Critical thinking abilities Ability to regularly travel to sitesWorking Conditions Home-basedRegular travel is required PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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