Clinical Research Associate 1

The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are
conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory
requirements.

• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines
• Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
• Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
• Provides regular site status information to team members, trial management, and updates trial management tools
• Completes monitoring activity documents as required by PRA SOPs or other contractual obligations 
• Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
• Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed
• Performs essential document site file reconciliation
• Performs source document verification and query resolution
• Assesses IP accountability, dispensation, and compliance at the investigative sites
• Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines
• Communicates with investigative sites
• Updates applicable tracking systems
• Ensures all required training is completed and documented

• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
• Clinical research experience
• Knowledge of ICH and local regulatory authority regulations regarding drug
  An advanced degree (e.g., M.S., M.B.A., PharmD, etc)