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