Clinical Trial Associate - East Coast - FSP

Job Summary: The Clinical Trial Associate (CTA) provides operational and administrative support to clinical trials throughout their lifecycle, ensuring consistency with applicable regulatory guidelines (ICH-GCP, client’s SOPs) and facilitates smooth execution of trial activities. Study management activities may include maintenance of information databases and trial tracking reports, coordination of clinical trial documentation and general support to ensure the successful and timely execution of clinical activities and deliverables. Key Responsibilities:

• Assist with organizing, updating and maintaining tracking systems and tools to support the conduct of clinical study from start-up to closeout
• Assist with the coordination and development of study management tools, monitoring tools, study manuals and training materials and presentations
• Schedule meetings, prepare and distribute meeting agendas, minutes, and follow-up action items for study teams
• Set up, organize and maintain study files and shared spaces in accordance with study requirements
• Coordinate and track study training
• Manage study sample and supply tracking and support interactions with vendors as needed
• Support the Study Management team with specific projects
• Effectively communicate with study team members and in collaboration with the study team, identifies and addresses study-related issues
• Perform routine quality checks on trial level documents to ensure completeness and accuracy
• Supports the timely, complete and compliant archiving in the TMF
• Participate in company, departmental and project team meetings including Investigator Meetings
• May assist with basic financial and budget tracking activities related to the clinical trial.

Requirements:

• BS/BA degree or degree in healthcare field required
• Direct experience supporting clinical operations activities, 1+ years in pharma/biotech company or 2+ years of experience in a CRO
• Very strong foundational understanding of clinical trials, and have prior experience in the administrative aspects of clinical operations
• Experience managing the TMF with a solid understanding of filing expectations at study, country, and site levels,
• Experience managing the CTMS, study team lists, SharePoint accesses
• Taking diligent meeting agendas/minutes
• Tracking and following up on action items with a fundamental understanding what goes into each action
• Tracking study plans & training compliance
• Maintaining ongoing systemic reviews, such as User Access Reviews, eSystems List Reviews, Global Vendor Listing Reviews
• Effective written and verbal communication skills, with the ability to work collaboratively within study teams
• Strong organization and interpersonal skills
• Foundational experience with eTMF systems and basic knowledge of essential documents to file study documents accurately with guidance
• Strong attention to detail
• Able to prioritize and manage multiple tasks with competing deadlines
• High sense of urgency and commitment to excellence in the successful execution of deliverables
• Demonstrates ability to identify issues and escalate appropriately to support timeline adherence
• Proficient with MS Office Suite (Excel, Word, PowerPoint) and project tracking tools

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