Assist in the cross-unit coordination both internal and external, inclusive of sub-contractors, for projects utilizing one or more Covance Services or sites.
+ University/college degree (life science preferred), or certification in a related allied health
profession(i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
+ In lieu of the above requirement, candidates with five (5) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
+ Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
+ Thorough understanding of the drug development process.
+ Working knowledge of Covance SOPs.
+ Experience as a Senior Clinical Research Associate, whether internal or external.
+ Minimum of four (4) years of relevant clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits).
+ In lieu of the above requirements, candidates with> five (5) years supervisory experience in a health care setting and four (4) years clinical research experience (including monitoring) in the pharmaceutical or CRO industries will be considered.
+ In lieu of the above requirements, candidates with five (5) years of site management and/or study/project coordinator experience will be considered.
+ Comprehensive understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
+ Comprehensive understanding of both site monitoring and study site management requirements.
+ Comprehensive understanding of applicable regional regulatory requirements.
+ Ability to work with minimal supervision.
+ Good planning and organization skills.
+ Good computer skills with good working knowledge of a range of computer packages.
+ Excellent verbal and written communication skills.
+ Ability to set clear expectations for junior staff on projects.
+ Ability to understand and work with financial information.
+ Ability to resolve project-related problems and prioritizes workload for self and team.
+ Ability to work within a project team.
+ Ability to work efficiently and effectively in a matrix environment.
+ I+ year additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
+ Local project coordination and/or project management experience.