Clinical Trials Associate

• Triage incoming emails, either as HelpDesk or other centralized/group email box.
• Process/track/distribute/upload designated clinical trial documents/artifacts, e.g., protocol deviations, site monitoring visit reports, essential regulatory documents (ERDs), etc. Generate/distribute Monthly/Quarterly reports regarding the 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 to internal and external stakeholders. Participate in centralized monitoring visits (CMVs).
• Provide Meeting/Webinar Support, i.e., distribute invites, track attendance, and complete/distribute meeting minutes/summaries to internal and external parties.
• Adherence 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 when required, including tracking CRA visit schedules and visit statuses, and sending to internal or external stakeholders as directed.
• Reviewing, tracking, and managing study/project documents and filing as appropriate.
• Track progress of tasks and projects.
• Assist CRAs, CSMs, and/or In-House CRAs as needed.

Job Requirements:

• Knowledge of applicable ICH/GCP/FDA guidelines/regulations in a pharmaceutical, clinical research, or clinical site, sponsor, or CRO setting (i.e., In-house CRA, Study Coordinator, IRB Coordinator, and Regulatory Coordinator/Associate/Specialist).
• Must have excellent time management skills.
• Able to identify activities along critical paths toward a specified deliverable.
• Demonstrated understanding of medical and clinical trials terminology, including general understanding of Clinical Site Monitoring, Essential Regulatory Documents, and Trial Master Files.
• Able to work independently or with minimal supervision and handle multiple tasks effectively while keeping up with rapid changes of 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.
• Must be self-motivated and have a positive attitude.
• Excellent organizational and coordination skills with strong attention to detail.