Senior Clinical Research Associate

South San Francisco  ‐ Onsite
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Keywords

Description

Primary Duties:
  • Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
  • Track progress of study including patient enrollment, monitoring visits
  • Review key study quality metrics (e.g., eligibility, tumor assessments, primary endpoint data, etc.)
  • Investigate queries, monitor discrepancies
  • Manage investigational product (IP) accountability and reconciliation process
  • Responsible for review or approval of IP release packages
  • Negotiate and manage the budget and payments for investigative sites, if applicable
  • Clinical data review of data listings and summary tables, including query generation, follow up, and resolution
  • Oversee performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to manager or CRO as appropriate


Skills:
  • Strong computer skills (MS Office)
  • Strong working knowledge of FDA & ICH/GCP regulations and guidelines
  • Thorough knowledge of clinical monitoring procedures
  • Strong analytical and assessment skills
  • Strong judgment and problem solving skills


Education: Bachelor's degree in a scientific discipline or equivalent

To find out more about Real please visit www.realstaffing.com
Start date
01/2014
Duration
6 months
From
Real Staffing
Published at
09.01.2014
Project ID:
647941
Contract type
Freelance
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