Clinical Research Associate II (No Remote Work)

Toolbox Medical Innovations - Carlsbad, CA

Full-time

Clinical Research Associate II (NO REMOTE WORK)

The Clinical Research Associate II (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.

Responsibilities:

  • Implement and monitor clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH/GCP guidelines
  • Assess the qualification of potential investigative sites, initiate clinical trials at investigative sites, instruct site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
  • Record site visit activities, including but not limited to, assessments of qualification initiation activities, observations of clinical conduct, instructions/training given to sites, and action items to be completed
  • Review and verify accuracy of clinical trial data collected, either onsite or remotely. Provide regular site status information to team members, trial management, and update trial management tools
  • Complete monitoring activity documents as required by Toolbox OPs or other contractual obligations
  • Work closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
  • Perform essential document site file reconciliation. Perform source document verification and query resolution
  • Assess IP accountability, dispensation, and compliance at the investigative sites.
  • Communicate with investigative sites
  • Ensure all required training is completed and documented
  • Facilitate supply management and ensure clinical sites have the necessary supplies to conduct studies according to applicable protocols
  • May be assigned additional Clinical Operations tasks
  • May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines
  • Help create a fun, rewarding and collaborative environment

Education/Skills:

  • Bachelor’s degree required, preferably in a Science discipline
  • Minimum of 3 years of Monitoring experience (IVD preferred)
  • Ability to travel up to 80% of the time
  • Ability to instill trust in our customers through a dedicated effort to achieve their goals with quality, speed and efficiency
  • Ability to handle difficult situations professionally and maintain a professional and caring demeanor
  • Proven ability to collaborate in a team environment and work independently
  • Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment
  • Must be responsible, creative and highly motivated

Works Closely With:

Manager of Clinical Operations, Director of Clinical Programs and CTA’s

Job Type: Full-time

Experience:

  • CRA / monitoring: 1 year (Preferred)