Clinical Trials Associate - Early Phase

External Description
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:

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

Perform other duties as assigned
The responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
Skills And Abilities

• Excellent skills in MS Office applications including Outlook, Word, Excel and PowerPoint
• Sense of urgency and ability to be adaptable in a fast-paced and rapidly changing environment
• Ability to work independently and as a team member
• Strong organizational and problem-solving skills
• Excellent written and verbal English as well as fluency of the language of the country of location
• Ability to handle multiple tasks and exercise independent judgment
• Strong interpersonal skills
• 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

• Skill sets and proven performance equivalent to the above
• Degree level qualification or equivalent experience plus a minimum of one years’ experience in a related role

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.