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Senior Clinical Research Associate
PSI CRO AGSenior Clinical Research Associate ensuring timelines and quality in clinical research projects at PSI. Building relationships with stakeholders while focusing on subjects’ rights and safety.
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Health insurance
- Paid time off
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant 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 Oncology trialsmonitoring GI studies
Soft Skills
communicationcollaborationproblem-solvingplanningmultitaskingteamwork