Clinical Research Associate - (US-MA-Waltham - 02455)

Minimum Education: None
Job Type: Full Time
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Responsibilities : Participates in clinical research programs by assisting with the development of study protocols, case report forms, clinical reports, performing site monitoring visits, and interfacing with site coordinators, field clinical staff, and other company representatives. Ensure that documentation from investigators and investigational sites meets requirements. Assist in designing, planning and implementing clinical research projects. Assist in the design of study protocol, case report forms, informed consent for sound and thorough data to support the device through the approval process. Review site coordinators, investigators, and field clinical staff, in collecting data in a timely manner that meets the protocol requirements. Organize data in systematic manner to allow for efficient and accurate clinical reports. Perform site visits to ensure regulatory and study requirements are being fulfilled. Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols. Assist in writing the clinical portion of Regulatory submissions. Interface with clinical, regulatory, sales, marketing and administrative staff as necessary to accomplish the above responsibilities. Perform other clinical duties when requested.<

Requirements : Bachelor degree in health profession, science and/or engineering field. Experience: Experience in the medical device or pharmaceutical industry, 1-2 years (CRA I) or 2-3 years (CRA II). Preferred . Excellent written and oral communication skills. Computer literacy, proficient in MS Office, Excel, PowerPoint, etc. Excellent organizational skills and attention to detail.

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