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Job Description
- Assists on project management ad-hoc activities, produces reports, assists on editing of project and trial documents, etc.
- Generates level of effort reports and assists in monitoring project status
- Drafts and submits project progress reports
- Coordinates team conference calls, generates and distributes meeting minutes from internal/client/vendor meetings as applicable
- Prepares, revises, analyzes and reconciles project documents, including standard operating procedures (SOPs), project management plan, risk management plan, training plan, metrics and findings reports, etc., within specified timelines
- Assists with clarification and resolution of findings from quality assurance audits
- Maintains assigned data points within project tracking systems according to the established conventions within specified times, including entry of findings
Job Requirements
- Bachelor’s degree
- Detail-oriented and able to multi-task/prioritize well, with proven ability to handle multiple tasks efficiently and effectively
- Strong working knowledge of Microsoft office and ability to obtain knowledge and master all clinical trial database systems and technical tools; experience with AI tools a plus
- Ability to effectively analyze project specific data/systems to ensure accuracy and efficiency
- Flexibility to reprioritize workload to meet changing project timelines
- Knowledge of FDA clinical trial guidelines and regulations
- Clinical research experience preferred
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