We are seeking an energetic and highly motivated individual to join our Clinical Operations team.  This position reports to the Head of Clinical Operations and is an 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