| Job Description: Clinical Scientist:|
Interested in clinical research and/or vaccine development? Here is an opportunity to gain experience in this field and to contribute to a large ongoing vaccine clinical trial.
Part-time contract employee needed to assist with reviewing clinical documents (ie, serious adverse event reports and scanned medical records) and compare with subject?s electronic case report form to identify unreported or incorrect information such as additional adverse events and surgical procedures, hospitalizations, concomitant medications and surgical details. Subjects are participating in randomized clinical trial to assess the efficacy of an investigational S. aureus vaccine. Subjects undergo an inpatient spinal surgery and are being closely followed for post-operative infections as well as other adverse events. Documents to be reviewed included discharge summaries, inpatient progress notes and medical records, laboratory reports including from microbiological cultures, and surgical operative reports.
Key tasks: To become familiar with trial related materials and reporting systems. Read redacted clinical serious adverse events reports and scanned medical charts documents and compared against information in an electronic case report form. Submit electronic queries to site staff related to key discrepancies. Review site staff responses to see if adequate. Facilitate the reporting of unreported safety events or infections as per trial protocol. Meet with clinical scientist/medical monitor to review and oversee work performed.
Skills/experience: Clinical training such as medicine or nursing required to allow for understanding and interpretation of clinical documents. No license to practice in US required. Past experience in clinical data review and clinical trials a plus but not required. Basic computer skills to facilitate learning key study-specific data systems.
Position Comments visible to MSP and Supplier: old request number 10945 and 12056