Clinical Trial Associate

Job Title CTA

Location US(319 N Bernardo Ave, Mountain View, CA 94043)

Job Purpose

The Clinical Trial Assistant (CTA) supports study teams in the planning, designing, executing, monitoring, and reporting of clinical trials.

The CTA acts as a partner for internal and external team members / key stakeholders ensuring alignment of activities with study projects and timelines.

The CTA is responsible for performing administrative tasks, coordinating activities, and maintaining study documents. The CTA, under the direction and guidance of the VP, Head of Clinical Operations will work independently but knows when to involve and / or collaborate with other functional members when needed.

Major Accountabilities

• To provide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s).
• To assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.
• To support the Clinical Operations teams with ongoing conduct of studies.
• To assist project teams with study specific documentation and guidelines as appropriate.
• To set up, organize and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal / external audits, final reconciliation and archival.
• To assist in quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.).
• To assist project teams with trial progress tracking by updating the Clinical Trial Management systems.
• To assist in co-ordination of Investigator payments, if applicable.
• To contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.).
• To attend project team meetings and generate meeting minutes.
• To assist the Project Manager and project team with Investigator Meeting coordination, activities preparation and generate meeting minutes.
• To assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and / or business development presentations.
• Other duties as assigned

Requirements :

• Bachelor's Degree in scientific discipline or health care preferred.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Understanding of Good Clinical Practices.
• 2+ years’ experience as a Clinical Trial Assistant in life sciences industry preferred
• Understanding of Good Clinical Practices
• Strong written and verbal communication skills
• Proficient in Microsoft suite of products; Microsoft Word, Excel, PowerPoint, Outlook
• Experience utilizing CTMS, EDC, TMS, and related software preferred
• Attention to detail, and excellent organizational and prioritization skills
• Motivated to work in a fast-paced, high-accountability environment
• Ability to efficiently perform multiple tasks and manage changing priorities
• English Chinese Bilingual is preferred
17 days ago