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Lead CRA (remote)

Location: Chicago Salary: competitive
Sector: Pharma & Biotech, Clinical Research, Operations Type: Contract
  • Assists the Clinical Project Manager to proactively organize and track all study activities, milestones and metrics
  • Performs on-site monitoring and study visit trainings
  • Performs co-monitoring visits with CRO CRAs and re-trains other CRAs as needed
  • Collaborates with team to maintain consistent CRF data quality and discrepancy resolution across sites
  • Assists CPM with sites and vendors issues and corrective action prevention plan resolutions
  • May assist in development of study tools and guidelines to be utilized by the sites
  • Identifies risks and quickly escalates them to the Clinical Project Manager as appropriate

Qualifications:

  • Previous lead CRA experience
  • CRO and sponsor CRA experience
  • In house and field monitoring experience
  • Strong working knowledge of pharmaceutical processes and requirements
  • Excellent verbal and written communication skills
  • Proficient in coordination and review of regulatory documents from study sites to ensure completeness, accuracy, and compliance at the site and in the Trial Master File (TMF)
  • Working knowledge of TMF/CTMS management with the ability to identify issues and provide resolution
  • Attention to detail and organizational skills
  • Working knowledge of ICH/GCP and FDA regulations
  • Computer skills including proficiency in the use of Microsoft Word, Excel, Powerpoint, and organization tools
  • Self-starter with minimum oversight required to accomplish goals
  • Ability to maintain day-to-day activities while being responsive to changing priorities

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