Sr. Clinical Research Associate

Job Tasks:

• Co-monitor site pre-study, initiation, routine monitoring, and study closeout visits with CSP CRA to assess CSP and site performance for studies managed by a CRO.
• Review all study monitoring tasks at study sites to ensure compliance with GCP, ICH, applicable regulations and company SOPs for CRO managed clinical trials.
• Assist with the collection, review and, tracking of site-specific study/essential documents.
• Performs ongoing reconciliation of the Trial Master File (TMF) with content from site files.
• Provide training to site personnel and CSP CRA personnel, as required
• Tracks and reports progress of study sites.
• For CRO managed trials, assists with timely reconciliation of data queries and implementation of process improvement/corrective action when needed.
• Participates in the development and review of source documents, Case Report Forms, edit checks, and may participate in User Acceptance Testing for various systems used in Clinical Research.
• Coordinates, assembles, and ship study related supplies as needed.
• Assists with creation and review of study tools/documents.
• Will require approximately 40% business travel internationally

Requirements:

• CNS experience a plus
• Knowledge of GCP/FDA/ICH regulations required.
• Have an extensive and broad understanding of clinical research.
• Have a working knowledge of the relevant SOPs.
• Have strong interpersonal and communication skills
• Attention to detail with the ability to prioritize and multi-task.
• Must have strong organizational skills
• Ability to work well under pressure and with tight schedules.
• must be proficient in MS Word and Excel,

Sthree US is acting as an Employment Business in relation to this vacancy.