Clinical Research Associate Trainee
Cato Research - Durham, NC

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Experience: Minimum of 3 years of experience in clinical research project management.

Education: Requires a Bachelor’s degree.

PRIMARY RESPONSIBILITY:
The trainee will go through the training program and upon completion will have the following responsibilities.
Conducts investigational site evaluation, initiation, periodic and termination visits. Serves as liaison between the sponsor and the investigator, serves as a resource for investigational site queries, reviews sponsor/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 events. Writes and submits written reports of investigational site findings. May be involved in organizing or participating in Investigator’s Meetings, clinical study report writing, and the development of Protocols, Study Procedure Manuals and Case Report Forms. Maintains a high level of professional expertise through familiarity with regulatory and clinical literature and continuous education.