This is a lead position. The Clinical Research Associate II manages the implementation of study
protocols at research sites. Responsibilities include but are not limited to: serving as lead
CRA for clinical studies; performing monitoring visits including site qualification,
initiation, monitoring and closeout visits; developing monitoring plan; maintaining contact
with study sites, report preparation and communications documentation; conducting training;
preparing for and participating in Sponsor and FDA audits; managing clinical project
assistants and associates.
Required qualifications: BA/BS degree or equivalent combination of education and experience in
a medical or scientific discipline; minimum 1 year monitoring experience; significant
technical, medical or industry experience in a clinical research setting; strong understanding
of Medical Terminology, Physiology, and Pathophysiology; working knowledge of Good Clinical
Practices; strong organizational skills; the ability to multi-task and work effectively in a
fast-paced environment; strong written and verbal communication and diplomacy skills;
professional demeanor and appearance; ability to travel 30%.
Preferred qualifications: BS in scientific discipline; 2+ years experience in a CRO.