Clinical Trials Associate

• Arrange and track system access for the project team
• Maintain and quality audit documents on project portals
• Assist with preparation and shipment of clinical trial documentation, including Investigator Site File
• Maintain version and quality control of project documentation and submit to trial master file
• Track and maintain project-related information, including site medical question and answer logs
• Generate and distribute minutes for project-related meetings, including Sponsor and Internal Management meetings
• Maintain current participating site and personnel information
• Arrange and track distribution of project-specific training to the project team
• Perform other duties as assigned

• Excellent written and verbal English
• Fluency in the language of the country of location
• Strong interpersonal skills
• Ability to work independently and as a team member
• Sense of urgency and ability to be adaptable in a fast-paced and rapidly changing environment
• Ability to handle multiple tasks and exercise independent judgment
• Strong attention to detail and focus on quality of work
• Strong organizational and problem-solving skills
• Excellent skills in MS Office applications including Outlook, Word, Excel and PowerPoint
• Knowledge and understanding of ICH, GCP, and FDA or EU directive regulations (as applicable)
• Degree level qualification or equivalent experience
• Minimum of one years’ experience in a related role
• Skill sets and proven performance equivalent to the above

• Equal employment opportunities regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law