Clinical Trials Administrator I (Silver Spring, MD)

The Clinical Trial Associate (CTA) supports study teams across all investigator sites, executing study activities, managing regulatory documents, and ensuring compliance with study protocols and guidelines. Skilled in multitasking and problem-solving, the CTA independently addresses complex tasks, may assume Clinical Research Associate duties with limited monitoring responsibilities, and provides project management support.
 

• Study Execution: Execute study activities per protocol, regulatory guidelines, and operational plans, including study start-up, conduct, and closeout.
• Documentation: Review study materials (IDB, protocols, CRFs, ICFs) and collect regulatory documents (e.g., 1572s, CLIA waivers).
• Project Management: Track compliance, maintain study trackers, take meeting minutes, distribute agendas, and assist with contracts and budgets.
• Regulatory and Compliance: Assemble regulatory binders, support compliance with SOPs and guidelines, and perform Trial Master File maintenance and QC.
• Support Functions: Manage sample collection oversight, support Investigator Meetings and trainings, and aid in EDC and IxRS specification processes.

• Bachelor’s degree in biological sciences or related field (or equivalent experience).
• Strong written and verbal communication, organization, and time management skills.
• Proficiency in MS Word, Excel, and Project; EDC system and CTMS experience preferred.
• Analytical and problem-solving skills with a keen attention to detail.

• Office-based with occasional lifting (up to 25 lbs); low to moderate noise level.
• Up to 5% travel may be required.

Department: Direct Clients
This is a full time position