Clinical Research Associate
Cato Research - Durham, NC

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Cato Research Ltd: A small-to-mid-sized CRO which values a reasonable work/life balance for its CRAs with a proven track record of retaining our CRAs for many years. PRESENTLY SEEKING A home-based experienced regional Clinical Research Associate for the Durham, NC.

• 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, 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) and applicable regulations.
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, 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.
• minimum of 2 years’ experience as a Clinical Research Associate (CRA) with primary site monitoring responsibilities
• knowledge of FDA, HPFB and/or international regulatory requirements and ICH required
• ability to travel 65% required
• Bachelor's degree required; R.N. or B.S. Nursing. strongly preferred
• ACRP certification preferred
Type of Work: Permanent, Full time
Location: Durham, NC
Contact: Website:

Cato Research - 9 months ago - save job