As the drug development business of Laboratory Corporation of America Holdings (Labcorp) and the world’s most comprehensive drug development #CRO service company, we have helped pharmaceutical and biotech companies develop 100% of the top 50 prescription drugs in the marketplace today.
Because of our broad experience and specialized expertise, we’re i...
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All details of site management as prescribed in the project plans
Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
Negotiation of study budgets with potential investigators and cooperation with Labcorp Drug Development legal department with statements of agreements
Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.
Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Labcorp Drug Development or client data management systems
Experience:
Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
Excellent understanding of Serious Adverse Event (SAE) reporting
Ability to resolve project-related problems and prioritize workload for self and team
You have previous clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits).
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