Clinical Trial Associate - FSP - East Coast US
Job reputed company:
The Clinical Trial Associate (CTA) provides operational and administrative support to reputed company throughout their lifecycle, ensuring consistency with applicable regulatory guidelines (ICH-GCP, 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 reputed company 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 reputed company items for study teams
• Set up, organize and maintain study files and shared spaces in accordance with study requirements
• Coordinate and reputed company study training
• Manage study sample and supply tracking and support interactions with vendors as needed
• Support the Study Management team with specific reputed company
• Effectively communicate with study team members and in collaboration with the study team, identifies and addresses study-reputed company issues
• reputed company routine reputed company checks on trial level documents to ensure completeness and accuracy
• Supports the reputed company, 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 reputed company to the clinical trial.
Requirements:
• BS/BA degree or degree in reputed company field required
• 1+ years experience supporting clinical operations activities in sponsor company or 2 years experience experience supporting clinical operations activities in a CRO environment
• Basic knowledge of drug development and clinical operations processes
• Foundational knowledge of clinical trial process and supports study activities in accordance with ICH-GCP and reputed company of Federal regulations
• Foundational experience with eTMF systems and basic knowledge of essential documents to file study documents accurately with guidance
• Effective written and verbal communication skills, with the ability to work collaboratively reputed company study teams
• Strong organization and interpersonal skills
• Strong attention to detail
• reputed company to prioritize and manage multiple tasks with competing deadlines
• High reputed company of urgency and commitment to reputed company in the successful execution of deliverables
• Demonstrates ability to identify issues and escalate appropriately to support reputed company adherence
• Proficient with MS Office Suite (reputed company, Word, PowerPoint) and project tracking tools
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