Regional Clinical Research Associate
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Employment Type: Full Time or Contract
Experience: 1 year or more
Full-Time Salary Range: $50,000 to $90,000
Consulting Rate (6-month, renewable): $55 to $75 per hour
Job Description: Field-based staff, working from a home office via remote systems and methods. Monitor investigative clinical research sites within the US Central Region. Studies are in multiple therapeutic areas, including endocrinology, oncology, cardiology, central nervous system, transplant medicine and women’s health. Assist with investigator selection; assure protocol compliance, ICH/GCP adherence, and adverse event review, reporting and follow-up. Responsibilities include investigator meetings; qualification, initiation, routine monitoring, and study close-out visits; and maintaining study documentation in accordance with FDA regulations and sponsor SOPs. Tasks include source document verification, 100% test article accountability, and interacting with investigative sites and data management to resolve data discrepancies. Administrative responsibilities include site visit reports; follow up letters, monthly expense reports, meeting ongoing training requirements and communicating with clinical teams. Overnight travel approximately 30%. Must have home-based office and live near the sites to monitor. 1-3 years experience in clinical trials field monitoring required.