We are seeking an energetic and highly motivated individual to join our Clinical Operations team.  This position  has the opportunity to significantly contribute to the growth and development of a top-tier Biotech company. The CTA position is focused on providing support associated with the planning, start-up, maintenance, and closeout of clinical trials. The ideal candidate will be proactive and detail oriented with a desire to be involved in all aspects of clinical trial execution.

• Assist with audit of central files
• Assist with the preparation of required study documentation and performs literature searches.
• Assist with dissemination of information to the project team members (including meeting minutes and action items)
• Distributes regular clinical project updates.
• Tracks clinical study center supplies and coordinate re-supply with Clinical Operations personnel and external vendors
• Assist the Director, Clinical Operations with tracking of financial documents.
• Assist with creation of presentations of clinical research study information.
• Assist with the preparation of training materials for investigational sites, in[1]house personnel, and new hires.
• Performs set up of new project files and maintains current project central files.
• Perform periodic reviews of the clinical study files for accuracy and completeness and resolves any deficiencies with general supervision.
• Responsible for tracking studies, patient information, timelines, payment schedules as well as central files and regulatory documents with general supervision.
• Provides assistance in the design, layout and creation of slide presentations.

• BS (with 2+ years), or MS (with 1+ year) experience in a clinical department (in a pharmaceutical, biotech or CRO environment) performing project coordination activities and maintenance of Central Files
• Basic understanding of regulatory issues related to Phase I-IV clinical research.
• Demonstrates excellent communication, interpersonal and organizational skills. Knowledge of project management tools and practices.
• Comprehensive knowledge of Microsoft Word, Excel, and PowerPoint
• Basic knowledge and understanding of GCP and ICH guidelines.
• Experience working with eTMFs strongly preferred