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Provide administrative, clerical, implementation and/or processing support to the project teams and stakeholders. Assist with document/process/report development, testing, tracking, distribution, and management. Coordina…
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, resp…
Skills: Clinical Site Monitoring, GCP Best Practices, Site Recruitment, Project Management, Regulatory Filings
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Sr. Clinical Research Associate - Belgium (French & Dutch Fluency)
Brussels, Brussels-Capital, Belgium · Remote OK
$58k–$79k/yr
Senior
Independently performs, coordinates and oversees all aspects of the clinical site monitoring services, assessing protocol and regulatory compliance as per Alimentiv’s and sponsor’s standard processes, ICH/GCP guidelines …
Skills: Clinical research, Site monitoring, Project management, Regulatory filings, GCP best practices
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Full-time
bachelor degree
Posted 36d ago
~40 hrs/week
Remote in Berlin, Germany
Responsibilities
Manage and deliver full clinical site monitoring services, including the design and oversight of project monitoring and regulatory filings. Act as a Lead CRA to mentor peers and serve as the primary liaison between the project team and sponsors.
Requirements
Requires a college diploma or degree with 4-6 years of related experience in clinical research. Must have strong communication skills and the ability to travel to study sites 5-8+ days per month.
Full 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.
\nMonitoring - Subject Expert
Act as subject matter expert, mentor, coach and/or provide performance feedback to manager for peers.
Assist 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 concerns.
May represent Director, Monitoring and Site Management or Manager, Clinical Site Management in BD initiatives with a site monitoring focus.
Site 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 tools.
Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria.
Investigational Site Monitoring
Primary clinical site contact.
May act as primary contact for any questions or issues that arise from investigational sites.
Oversee overall integrity of the study to promote positive working relationships with the site and staff.
Facilitate and support site staff with access to study systems and ensure sites are compliant with project specific training requirements.
Ensure all site related issues are followed until resolution.
Coordinate 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 lifecycle.
Qualifications
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 study sites approximately 5–8+ days per month, depending on project and business needs.
Working Conditions
Home-based
Regular travel is required
\n
Stay Alert to Recruitment Scams We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.
Related keywords
Clinical Research AssociateCRAGCPSOPClinical Site MonitoringPatient RecruitmentCRFRegulatory FilingsClinical TrialsSite ManagementHealthcareClinical Study Delivery
Industry-leading specialty GI contract research organization (CRO) transforming clinical trial outcomes and accelerating the development of life-changing therapies. We bring together deep GI expertise, advanced medical imaging solutions, clinical operation excellence and cutting-edge precision medicine/laboratory services.
With a global network of 5,000+ sites in 60+ countries and growing, we expedite study activation and maximize patient enrollment, ensuring efficient and impactful clinical trials. Trusted by pharmaceutical and biotech partners, we support over 70% of all IBD compounds in development today – delivering customized end-to-end solutions to bring novel therapies to market.
As a full-service CRO, our offering is tailored to meet your specific clinical research needs:
• Clinical Trial Services
• Medical Monitoring
• Medical Imaging Solutions
• Medical Research & Development
• Medical Writing
• Precision Medicine/Biomarkers
• Clinical Pharmacology
• Histopathology via Specialty Lab, AcelaBio
• Spatial Biology
• Statistics
• Real-World Evidence
Headquartered in London, Ontario, Alimentiv operates globally across Canada, the US, Europe, Asia-Pacific, and Latin America.
Offices: 800 Collip Circle, 104, London, Ontario N6G 4X8, CA · 6220 Greenwich Dr, 101, San Diego, California 92122, US · Pietersbergweg 17, Amsterdam, NL · Suite 6, Level 2 29-31 Lexington Drive, Bella Vista , NSW 2153, AU · 150 King St W, 315, Toronto, Ontario M5H 1J9, CA
Medical ImagingMedical Research & DevelopmentClinical Trial ServicesPrecision MedicineBiomarker DiscoveryHistopathologyBiostatisticsReal-World EvidencePhase 1-4 Clinical TrialsIBD
Industry-leading specialty GI contract research organization (CRO) transforming clinical trial outcomes and accelerating the development of life-changing therapies. We bring together deep GI expertise, advanced medical imaging solutions, clinical operation excellence and cutting-edge precision medicine/laboratory services.
With a global network of 5,000+ sites in 60+ countries and growing, we expedite study activation and maximize patient enrollment, ensuring efficient and impactful clinical trials. Trusted by pharmaceutical and biotech partners, we support over 70% of all IBD compounds in development today – delivering customized end-to-end solutions to bring novel therapies to market.
As a full-service CRO, our offering is tailored to meet your specific clinical research needs:
• Clinical Trial Services
• Medical Monitoring
• Medical Imaging Solutions
• Medical Research & Development
• Medical Writing
• Precision Medicine/Biomarkers
• Clinical Pharmacology
• Histopathology via Specialty Lab, AcelaBio
• Spatial Biology
• Statistics
• Real-World Evidence
Headquartered in London, Ontario, Alimentiv operates globally across Canada, the US, Europe, Asia-Pacific, and Latin America.
Offices: 800 Collip Circle, 104, London, Ontario N6G 4X8, CA · 6220 Greenwich Dr, 101, San Diego, California 92122, US · Pietersbergweg 17, Amsterdam, NL · Suite 6, Level 2 29-31 Lexington Drive, Bella Vista , NSW 2153, AU · 150 King St W, 315, Toronto, Ontario M5H 1J9, CA
Medical ImagingMedical Research & DevelopmentClinical Trial ServicesPrecision MedicineBiomarker DiscoveryHistopathologyBiostatisticsReal-World EvidencePhase 1-4 Clinical TrialsIBD