LSKB is hiring a Senior Clinical Research Associate

LSKB is hiring a Senior Clinical Research Associate

Responsibilities and Duties

Essential Duties & Responsibilities:

  • Assist protocol, IB and CRF development
  • Provide monitoring guidance
  • Plan and assist study start-up activities such as the creation of Site Initiation Presentations, CRF Completion Guidelines and various study tracking and management documents
  • Perform pre-site selection, site initiation, interim, close-out and co-monitoring visits
  • Provide leadership and professional expertise with consent procedures, protocol compliance, GCP/ICH Guidelines and other applicable regulatory requirements, and assurance of good site performance
  • Review and management of monitoring reports and follow-up within project-specific timelines
  • Maintain project tracking system of subject and site information

Qualifications and Skills

Experience and Education Required:

  • Bachelors level degree in life sciences, pharmacy, nursing or RN preferred.
  • 5 years clinical monitoring experience.
  • In-depth knowledge of Good Clinical Practice/ICH guidelines.
  • Demonstrate leadership abilities.
  • Position requires approximately 10% travel (50% during peak times).
  • Knowledge of the principles and practices of basic computer applications used in general office settings, including word processing, spreadsheet, database management, and presentation software and Internet search engines.
  • Basic math and standard English grammar and usage.

Job Type: Full-time

 

Send resumes to angieprice@lskbiopharma.com