CRA II (Regional or Office Based)

Dallas, TX, Chicago, IL or Denver, CO

We are partnering with a full service Contract Research Organization with an excellent reputation for quality and therapeutic expertise. This organization has a broad base of therapeutic experience and services to their clients in the industry.

The position, created through organic business growth, will work creatively with research sites to facilitate and supervise the conduct of clinical trials, build relationships, and effectively communicate ideas and results throughout a broad spectrum of organizational levels and reporting methods.

• B.S. degree in the life sciences or nursing, Master’s degree is a plus!
• 3+ years of independent field monitoring experience as a CRA
• Ability to travel up to 70% of the time on a nationwide basis
• Therapeutic Areas: Cardiovascular Stent is a MUST
• Previous experience monitoring medical device trials
• Demonstrated knowledge of GCP, ICH and FDA guidelines
• Strong verbal and written communication skills
• Strong organizational skills and attention to detail

• On-site monitoring of clinical trials to ensure compliance with GCPs, clinical protocol and SOP’s including source documentation verification and CRF (case report form) review
• Conduct monitoring visits for pre-study, site initiation, routine monitoring and close out
• Generate, review and resolve queries at assigned sites
• Serve as primary contact and resource to site during clinical trial for protocol and procedural related questions
• Provides site support for remote data capture, monitoring data capture remotely, reviewing for completeness and consistency, and generating and resolving queries in between monitoring visits
• Assist in the close out of clinical studies through the oversight of clinical sites through data lock, resolving final queries and completing closeout visits
• Draft trip reports and expense reports to be submitted for review
• Schedule additional monitoring visits in accordance with pre-determined monitoring schedule and study budget

We will only be able to respond to those inquires who meet the stated requirements. Please include the position ID (CC-1648) in the subject lined of your correspondence. Please forward your credentials in confidence to: recruiter7@ccesearch.com (Word format please).

To review additional opportunities, please visit our website at: www.ccesearch.com