Clinical Research Associate
Technical Resources International


Job Info


Responsibilities:

  • Provides site management and monitoring support for sponsored clinical studies; primarily Phase I and II, with limited Phase III and IV.
  • Performs on-site pre-study/qualification, initiation, routine, and close-out visits. Prepare site visit reports and provide assistance to site staff in resolving deficiencies.
  • Educates and trains site and study staff in management of sponsored studies, including assurance to regulatory and International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) compliance.
  • Collects and processes regulatory documentation for investigational studies in compliance with required guidelines.
  • Assist in protocol, Informed Consent, and CRF design and review.
  • Develops and demonstrate understanding of and apply therapeutic area knowledge to assignments and project-related issues.
  • Appropriately resolves issues related to trial monitoring and management with guidance from Project Manager.
  • Decisions are made independently and with some supervision from Director, Clinical Operations/Project Management or Project Manager.
  • Tasks are primarily intellectual and require exercise of discretion and independent judgment.


Job Requirements
Requirements:
  • BS/MS/RN or equivalent in scientific or health care field; CRC experience a plus.
  • Four years of pharmaceutical, clinical, or biological research experience with 2-3 years of CRA experience
  • Working knowledge of SOPs along with Food and Drug Administration and ICH/GCP guidelines.
  • Good communication, organizational, and writing skills.
  • Develops and applies efficient computer tools to carry out job functions.
  • Attention to detail, ability to work in a team environment.
  • Dependable, assumes responsibility and accepts, supports, and positively facilitates change.
  • Ability and availability to communicate with sites in different US time zones.
  • Has the ability to travel (on avg. 50% of time), including international travel.




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