Clinical Trial Associate

The Clinical Trials Associate is responsible for providing administrative and project tracking support to the clinical project team, ensuring tasks for all assigned projects with Project Delivery services are performed timely and accurately.

RESPONSIBILITIES:

Tasks may include but are not limited to:

• Arrange and track system access for project team (Project Managers, Lead CRAs, CRAs, etc.)
• Maintain and quality audit to assure the most recent revisions of documents are on project portals
• Assist project team 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
• Assist with the tracking and maintenance of project related information, including site medical question and answer log
• Generate and distribute minutes for a range of project related meetings, including Sponsor and Internal Management
• Maintain current participating site and personnel information
• Arrange and track the distribution of project specific training to the project team

The responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

What you will bring to the role:

• Excellent written and verbal English as well as fluency of the language of the country of location
• Ability to work independently and as a team member
• Ability to handle multiple tasks and exercise independent judgment
• Strong attention to detail and focus on quality of work
• Knowledge and understanding of ICH, GCP, and FDA or EU directive regulations (as applicable)

REQUIREMENTS:

• Bachelor’s degree education or equivalent experience
• A minimum of one years’ experience in a related role in Clinical Research