Sr Clinical Research Associate at Labcorp Drug Development

Responsibilities include:

• 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).