PSI CRO
Contract Research Organization
MedicalMonitor(Gastroenterologist)
“Medical Monitor (Gastroenterologist) at PSI CRO. Skills: Medical monitoring, Patient safety, Clinical studies. Act as primary contact. Provide input for regulatory responses”
Industry & Context.
Problem-solving
What They're Looking For.
Must Have
Medical Doctor degree, 10 years Gastroenterology practice, Proficiency with MS Office
Nice to Have
Clinical Research experience
What You'll Do.
Act as primary contact
Provide input for regulatory responses
Monitor trial participant safety
Participate in recruitment boost
Participate in retention activities
Present on medical matters
Develop trial-specific documents
Review trial-specific documents
Manage ongoing trial risks
Perform ongoing medical review
Review protocol deviations
Review SAE narratives
Support Pharmacovigilance team
Interact with sponsor on safety issues
Review IND/SUSAR Safety Reports
Review updates/amendments
Review annual IND reports
Participate in management of committees
Support reconciliation of databases
Review clinical study reports
Provide medical expertise
Prepare for trial audits
Participate in trial audits
Follow up on audit findings
Participate in feasibility assessment
Participate in bid defense meetings
Act as medical expert
Provide therapeutic expertise
How You'll Work.
Team & Collaboration
Global clinical studies; Business partners; Trial teams; Pharmacovigilance team; Data Management; Sponsor; Medical professionals
Communication Scope
Presentation skills
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