
Detail-oriented Clinical Trials Assistant with a background in supporting clinical research operations, managing study documentation, and fostering cross-functional collaboration within regulated environments. Exceptional organizational and communication skills developed through experience in clinical research and management roles. Proven ability to effectively manage competing priorities while ensuring meticulous documentation and contributing to team success in achieving operational objectives. Eager to leverage expertise for continued growth in clinical operations, clinical trial management, and research administration.
· Review, organize, and file essential study documents in accordance with company SOPs, ICH-GCP guidelines, and regulatory requirements.
· Partner with Clinical Research Associates (CRAs), Regulatory and Start-Up (RSU), and cross-functional teams to support study feasibility, start-up, maintenance, and closeout activities, including, but not limited to:
· Conduct site outreach to assess investigator interest and site capability for participation in clinical trials.
· Generate and manage Confidential Disclosure Agreements (CDAs) and perform investigator debarment screenings to support feasibility assessments and site selection activities.
· Support site activation through the collection, quality review, tracking, and filing of essential regulatory documentation required for Green Light Activation of Site (GLAS) binders.
· Ensure site activation documentation is complete, compliant, and approved according to study timelines.
· File IRB approvals, distribute and maintain protocol amendment documentation, and update site-specific informed consent forms (ICFs) during maintenance.
· Maintain Trial Master File (eTMF), Veeva, and CTMS records across multiple studies, ensuring accuracy, completeness, and inspection readiness.
· Run and review study reports to identify discrepancies and support ongoing data quality and document compliance efforts.
· Review TMF documentation during study closeout to identify and resolve missing, incorrect, or duplicate records.
· Collaborate with CRAs and investigative sites to obtain outstanding documentation prior to final monitoring visits and study archival activities.