Clinical Trials Associate II

The Clinical Trials Associate is responsible for the coordination of clinical research studies in compliance with U.S. and international regulations under the guidance of a Clinical Manager or Clinical Director.

• Clinical Trials Coordination
  
  * Supports with the development of clinical trial protocols
  
  * Reviews clinical study data
  
  * Assists with development of case report forms
  
  * CTA is responsible for effective communication with clinical trial sites
  
  * Assists with analyses of study data


• Reviews and Monitors Clinical Study Data
  
  * Reviews data as it comes in from sites
  
  * Documents errors and communicates to Manager 
  
  * Communicates with sites to correct errors
  
  * Assists Manager with study management


• Study Master File Maintenance
  
  * Sets up Study Master File and Study Master File Tracker at the beginning of each study
  
  * Receives, QC’s, scans and files documents in Study Master File
  
  * Provides status of documents to Clinical Management


• Collection of Site Start-Up Documents
  
  * Communicates directly with site staff to obtain site start-up documents
  
  * Prepares Regulatory Binders and provides to sites prior to Site Initiation Visit (SIV)
  
  * Obtains site documents from Regional Clinical Research Associates during trial
  
  * Receives, QC’s, scans, and files site documents in Study Master File
  
  * Provides status of site documents in Study Master File to Regional Clinical Research Associates prior to Monitoring Visits


• Establishes and Maintains Tracking of Critical Trial Information
  
  * Team and site contact information
  
  * Site status information
  
  * Enrollment trackers
  
  * Adverse event trackers
  
  * Site payment trackers and site payments


• Team Support
  
  * Scheduling meetings, set up of AV, teleconference or video conference equipment
  
  * Preparation of relevant materials
  
  * Support IP shipment and shipment of other materials to sites

- Bachelor's Degree with background in science or equivalent work experience Preferred

- CTA – 0- 2 years of work experience as a CTA

- CTA must demonstrate the following: • Understanding of required regulatory documents for the study. • Effective communication and understanding of the role with sites; with both