PSI CRO AG

Senior Clinical Research Associate

PSI CRO AG

full-time

Posted on:

Location Type: Remote

Location: California • United States

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Job Level

Senior

About the role

  • Conduct and report all types of onsite monitoring visits
  • Be involved in study startup (if applicable)
  • Perform CRF review, source document verification and query resolution
  • Be responsible for site communication and management
  • Supervise study activities, timelines, and schedules on the country level
  • Be a point of contact for in-house support services and vendors
  • Be involved in quality control, such as compliance monitoring and reports review
  • Participate in feasibility research
  • Support regulatory team in preparing documents for study submissions

Requirements

  • College/University degree in Life Sciences or an equivalent combination of education, training & experience
  • Independent on-site monitoring experience in the USA (5 years minimum)
  • 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) is 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)
Benefits
  • Hands-on involvement in every aspect of the study
  • Career advancement opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
on-site monitoringCRF reviewsource document verificationquery resolutionquality controlcompliance monitoringfeasibility researchclinical project participationmonitoring complex Oncology trialsmonitoring GI studies
Soft Skills
communicationcollaborationproblem-solvingplanningmultitaskingteamwork