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 Job #02871 Email this job to a friend
About our client
Our client is a world-leading CRO, which has served the pharmaceutical, biotech and healthcare industries for over 25 years.
Position Location
Regional Clinical Research Associate (Office/Home-Based) Southeast, USA
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Monitor activities at clinical study sites to ensure adherence to GCPs, SOPs and study protocols
2) Review regulatory documents (as required)
3) Prepare site visit reports
4) Oversee multiple projects and work both independently and in a team environment
5) Participate in study development and start-up processes (as required)
6) Review protocols and design and/or review CRFs
7) Prepare ICFs and develop study documents
8) Organize and be present at Investigator meetings
9) Work with management on monitoring strategy and/or developing project-specific CRA training
10) Participate in clinical training programs
11) Maintain current knowledge of developments in the clinical research field (as needed)
Requirements
1) BS/BA
2) Minimum 1-year of monitoring experience or combination of on-site monitoring and Clinical Research Coordinator experience
3) Experience in oncology
4) Knowledge of medical terminology and clinical monitoring process
5) In-depth therapeutic and protocol knowledge (as provided in company training)
6) Excellent communication skills (verbal and written)
7) Superb interpersonal and organizational skills as well as keen attention to detail
8) Proficient in computers (MS Office)
9) Customer service orientation
10) Willingness to travel – up to 65% (regionalized, depending on project needs)

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