- 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
- 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.