Clinical Trials Associate

About the role

Triage incoming emails for a HelpDesk or other centralized/group email box. Process, track, distribute, and upload designated clinical trial documents and artifacts such as protocol deviations, site monitoring visit reports, and essential regulatory documents (ERDs). Generate and distribute monthly/quarterly reports regarding documentation to internal and/or external stakeholders.

Review information in centralized databases (e.g., patient recruitment/accrual, clinical data entered as EDC), resolve queries, provide analysis assessments, and create/distribute periodic reports. Participate in centralized monitoring visits (CMVs). Provide meeting/webinar support by distributing invites, tracking attendance, and completing/distributing meeting minutes/summaries.

Adhere to strict project timelines and expectations. Troubleshoot issues by applying existing knowledge to solve new problems. Create and maintain study-specific contact lists. Assist with other operational activities, including tracking CRA visit schedules and statuses, and sending updates to stakeholders as directed. Review, track, and manage study/project documents and filing. Track progress of tasks and projects. Assist CRAs, CSMs, and/or In-House CRAs as needed.

Requirements

• Knowledge of applicable ICH/GCP/FDA guidelines/regulations in a pharmaceutical, clinical research, or clinical site, sponsor, or CRO setting (e.g., In-house CRA, Study Coordinator, IRB Coordinator, Regulatory Coordinator/Associate/Specialist).
• Excellent time management skills and ability to identify activities along critical paths toward a specified deliverable.
• Demonstrated understanding of medical and clinical trials terminology, including general knowledge of Clinical Site Monitoring, Essential Regulatory Documents, and Trial Master Files.
• Ability to work independently or with minimal supervision, handle multiple tasks effectively, and adapt to rapid changes in priorities without loss of efficiency.
• Demonstrated understanding of sponsor-specific requirements and Standard Operating Procedures/Project Work Instructions.
• Excellent professional writing and verbal communication skills.
• Self-motivated with a positive attitude.
• Strong organizational and coordination skills with attention to detail.