Senior Clinical Project Assistant (CPA)

• Set up and maintain the Trial Master File.
• Generate and maintain study-specific electronic tracking tools for the following: regulatory documents, monitoring visit intervals and reports, screening and enrollment, protocol deviations, serious adverse events (SAEs), and study supplies.
• Coordinate and ensure proper shipment and tracking of clinical supplies (e.g., case report forms, site regulatory binders, diaries, etc.) to the site.
• Prepare the study specific forms for inclusion in the site regulator binders (e.g., screening and enrollment logs, monitoring visit log, delegation of authority log, etc).
• Review, track, and file screening and enrollment information from the clinical sites.
• Review, track, and file updates to regulatory documentation.
• Review, track, and process trip report packages.
• Interface with Clinical Research Associates (CRAs) and clinical sites to address issues and resolve problems as directed by the Clinical Project Manager.
• Review and reconcile the Clinical Main Study File and ensure that all study-related documents collected from or submitted by the clinical sites are filed in the Clinical Main Study File.
• Index and prepare Clinical Main Study File contents for return to the Sponsor at the close of the clinical trial.
• Attend project meetings and assist with preparing the meeting minutes and other reports needed for the study
• Attend SOP training meetings and ensure that training records are updated.
• Assist Clinical Project Manager with any day-to-day study operational issues.
• Perform other general duties as required to support the company.
• Bachelor’s degree or the equivalent in a scientific discipline and at least 2 years of experience in clinical operations, research, and/or clinical laboratory
• Knowledge of FDA regulations respecting ICH GCP guidelines and clinical trials conduct.
• Excellent accuracy and attentiveness to detail
• Good written and verbal communication skills; good interpersonal skills
• Good organizational skills with ability to multitask and prioritize workload
• Good computer skills (Word, Excel, Powerpoint, Email)
• Ability to work within a team matrix
• Ability to handle stressful situations and deadlines and work on multiple projects
• Ability to work productively and efficiently with minimal supervision

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