Clinical Trial Associate

Position Summary:

Seeking a highly motivated CTA to provide administrative and operational support to Clinical Operations.

Responsibilities (including, but not limited to):

• Organize, participate in, and maintain agendas and meeting minutes for all internal and cross-functional team meetings. Review external meeting minutes as required.
• Work closely with our clinical operations team to coordinate, track, and manage logistics in support of studies (e.g. review study plans, assist with eTMF reviews).
• Update and maintain internal trackers (e.g. central enrollment tracker, investigator engagement tracker, bioanalytical sample tracker) and implement updates into ad-hoc presentations and reports as required.
• Maintain internal Clinical Operations study files and perform periodic reconciliations of documents to ensure all material is present and versioned correctly.
• Create and maintain study personnel contact lists for all studies and KOLs by disease indication.
• Assist with the review of study-related documents for clinical studies (e.g. protocol, IB, ICFs).
• Assist with the facilitation of important external meetings (e.g. Clinical Advisory Board meetings): outreach, scheduling, execution of CDAs and contracts, travel arrangements, presentations, agendas, and minutes.
• Assist with bioanalytical sample tracking and management of central and third-party labs (sample shipment and analysis timelines).
• Assist with the review of central and third-party lab documents (e.g. Lab Manual, site flowcharts).
• Assist with monitoring trip report across the program.

Requirements, Education, Experience & Skills:

• Relevant education and training required; Bachelor’s degree in administrative, science or medical areas of study is a plus.
• At least 3 years of successful administrative experience in biotech/life sciences, health care or clinical study management (title commensurate with experience, with emphasis on eTMF experience)
• Prefers to contribute as both independent, self-starter, and a collaborative team member.
• Excellent organizational skills; prefers and can adapt to multiple priorities in a fast-paced and fluid work environment.
• Excellent verbal and written communication skills.
• Excellent computer skills, including Microsoft Office Suite: Calendar, Word, Excel, and PowerPoint are essential. SharePoint and SmartSheet preferred.
• Veeva TMF working knowledge and for senior level, demonstrated knowledge of ICH-GCP, FDA and international regulatory requirements, eTMF management/oversight, and inspection readiness
• Demonstrated multi-tasking and project management skills.