Clinical Research Associate
Conducts investigational site selection, initiation, periodic and termination visits. Serves as liaison between the sponsor and the investigator, serves as a resource for investigational site queries, reviews investigator contracts, and participates in project team meetings and sponsor telephone conference calls on a regular basis.
Travels to investigational sites to verify that: the rights and well-being of human subjects are protected; the reported trial data are complete, accurate, and verifiable per source documents; and that the trial is conducted in compliance with the currently approved protocol, Good Clinical Practices (GCPs), and Standard Operating Procedures (SOPs).
Other responsibilities include verifying proper storage conditions, accountability, and disposition of the investigational products; maintenance of up-to-date and accurate investigator study files; and accurate recording and reporting of adverse experiences. Writes and submits written reports of investigational site findings. May be involved in organizing or participating in Investigator’s Meetings, study report writing, and the development of Protocols, Case Report Forms and Study Procedures Manuals.
Maintains a high level of professional expertise through familiarity with regulatory and clinical literature and continuous education.
• 2+ year experience as a clinical research associate (CRA) with primary site monitoring responsibilities
• Bachelor’s degree required; R.N. or B.S.N. strongly preferred
• Knowledge of FDA, HPFB and/or international regulatory requirements and ICH required
• ACRP certification preferred
• Ability to travel 65% required
Cato Research - 2 years ago