Work Schedule
Other
Environmental Conditions
Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Manages all aspects of assigned clinical trials involving patient and healthy subject populations in both
inpatient and outpatient settings. Acts as liaison between functions (i.e. PM, investigator, research team, etc.). Ensures client requirements and specifications are communicated to the research teams and any issues/questions raised by the research team or investigators are communicated back to the project leads and client (as needed) for resolution.
Qualifications
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
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• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
• Knowledge of Phase I processes and strong knowledge of clinical study operations
• Knowledge of FDA regulations and ICH GCP guidelines
• Solid computer skills with working knowledge of Microsoft Office applications
• Good time management and multi-tasking skills
• Solid written and verbal communication skills
• Strong organizational and prioritization skills with the ability to prioritize workload and adapt to changing study needs
• Favorable consulting skills to act as a liaison between external and internal groups
• Knowledge of budgeting/forecasting/planning projects