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PSI CRO AG

Senior Clinical Research Associate

PSI CRO AG

. Conduct and report all types of onsite monitoring visits .

Posted 11/12/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates extensive experience in on-site monitoring of clinical trials, particularly in Oncology, with a strong focus on compliance, data quality, and subject safety. Proficient in managing site communications and timelines while collaborating effectively with clinical sites and regulatory teams.

Highest-signal resume keywords
On-Site Monitoring ExperienceClinical Trial ManagementOncology Trials MonitoringRegulatory Document PreparationMS Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
CRF ReviewSource Document VerificationQuery ResolutionFeasibility ResearchCompliance MonitoringData Quality ComplianceClinical Research StandardsMonitoring Visits Phase I–IIIExperience with RadiopharmaceuticalsExperience with GI Studies
Soft Skills
Communication SkillsCollaboration SkillsProblem-Solving SkillsAbility to MultitaskDynamic Team Environment
Industry Keywords
Life SciencesClinical ResearchOncologyBreast CancerIBDChron's DiseaseUlcerative ColitisClinical ProjectsStudy StartupSite Communication

About the role

Key responsibilities & impact
  • Conduct and report all types of onsite monitoring visits
  • Participate in study startup, if applicable
  • Perform CRF review, source document verification and query resolution
  • Manage site communication
  • Supervise study activities, timelines and schedules at the country level
  • Serve as a point of contact for in-house support services and vendors
  • Participate in quality control, including compliance monitoring and report review
  • Participate in feasibility research
  • Support the regulatory team in preparing documents for study submissions
  • Build and maintain relationships with clinical sites and investigators
  • Ensure timelines, targets and clinical research standards
  • Focus on subjects’ rights, safety, well-being and data quality compliance

Requirements

What you’ll need
  • College/University degree in Life Sciences or an equivalent combination of education, training & experience
  • Minimum 5 years of independent on-site monitoring experience in the USA
  • Experience in all types of monitoring visits in Phase I–III
  • Participation in clinical projects as a Senior Monitor
  • Experience monitoring complex Oncology trials required
  • Experience with radiopharmaceuticals and/or breast cancer preferred
  • Experience monitoring GI studies (IBD, Chron's, UC) preferred
  • Full working proficiency in English
  • Proficiency in MS Office applications
  • Ability to plan, multitask and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills
  • Ability to travel up to 80%
  • Valid driver’s license (if applicable)
  • Must not require a work visa for employment or continued employment now or anytime in the future

Benefits

Comp & perks
  • Hands-on involvement in every aspect of the study
  • Career growth opportunities
  • Work on challenging full-service clinical research projects
  • Opportunity to grow with a people-focused company