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Freelance Senior Clinical Research Associate
PSI CRO AG. Conduct and report all types of onsite monitoring visits .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in conducting onsite monitoring visits and managing clinical site communications while ensuring compliance with regulatory standards. Proficient in supporting Oncology, Hematology, and Infectious disease studies with a strong focus on data quality and subject safety.
Highest-signal resume keywords
Onsite Monitoring ExperiencePhase II and III MonitoringClinical Site ManagementFluency in Dutch and EnglishIntermediate to Advanced MS Office
ATS Keywords
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Hard Skills
CRF ReviewSource Document VerificationQuery ResolutionCompliance MonitoringQuality Control
Soft Skills
Relationship BuildingCommunication Management
Certifications & Qualifications
BSc or MSc in Life Sciences
Industry Keywords
Oncology StudiesHematology StudiesInfectious Disease StudiesClinical TrialsSite Supervision
About the role
Key responsibilities & impact- Conduct and report all types of onsite monitoring visits
- Perform CRF reviews, source document verification and query resolution
- Manage site communication
- Manage sites
- Supervise study activities, timelines, and schedules for each site
- Act as a point of contact for in-house support services and vendors
- Support quality control, including compliance monitoring and report review
- Build and maintain relationships with clinical sites and investigators
- Ensure subjects’ rights, safety and well-being and quality of data compliance
Requirements
What you’ll need- BSc or MSc in Life Sciences (or similar), or an equivalent combination of education, training & experience
- Independent on-site monitoring experience in Belgium, ideally on multiple projects at a time
- Demonstrable experience in all types of monitoring visits in Phase II and/or III
- Experience supporting Oncology/ Hematology and Infectious disease studies
- Fluency in Dutch and English, with professional proficiency in French
- Full and clean driver's license
- Ability to travel
- Intermediate to Advanced knowledge of MS Office
Benefits
Comp & perks- Professional development and career support
- Recruitment process guidance and support