In-House Sr. CRA

Summary:

This individual will join the Clinical Development team as a Sr. Clinical Research Associate (SR. CRA) who will report to the Clinical Trial Manager (CTM). The Sr. CRA is responsible for assisting with the design, administration, and monitoring of clinical trials; monitoring and managing clinical data from collection through locked database; and ensuring compliance with clinical protocols, their objectives, and ICH and GCP guidelines.

Responsibilities:

  • Assist with the design of clinical studies
  • Coordinate investigational site startup activities including, but not limited to, the creation, preparation, and shipment of documentation (e.g., ICFs, CRFs, study manuals, study binders, etc.), organizing Ethics Committee submissions, facilitating completion of clinical study agreements and budgets, and shipment of clinical supplies
  • Work closely with the CTM for each clinical study to manage contract vendors (e.g., CRAs) and Clinical Research Organization (CROs) to ensure all monitoring activities are conducted according to the Clinical Monitoring plan and relevant SOPs
  • Coordinate and maintain relevant tracking systems subject screening, enrollment, study visits, data entry, query resolution, etc.
  • Review clinical databases on a real time basis to identify/resolve data entry issues, track and manage the query process, and to identify/report evolving trends in the data
  • Perform investigative site qualification, study initiation, interim monitoring, and close-out visits; co-monitor and train contract CRAs for these activities
  • Participate in project team meetings and conference calls to review progress of ongoing clinical trials
  • Assist clinical and regulatory operations staff with additional projects and tasks as determined by department and organizational needs
  • Approximate travel 50%, with higher travel during certain periods

 

Requirements:

  • Minimum 5 years’ experience as a CRA in the biotechnology or pharmaceutical industry; experience in gastroenterology or hepatology preferred
  • Completed (or is in the process of completing) a CRA certification Course
  • BS degree in a health-related science or equivalent (e.g., nursing)
  • Proficient knowledge of GCP and ICH and medical terminology
  • Mature, hard-working, team player that thrives in a fast-paced working environment
  • Ability to prioritize and multitask to ensure tasks are completed on or ahead of time
  • Strong interpersonal and written communication skills
  • Excellent organizational and planning skills with attention to detail
  • Highly competent in Microsoft Office Suite including MS Word, Excel, PowerPoint