A growing CRO is looking for a Clinical research associate ii. This candidate must have Phase II-III experience. They will provide support to clinical operations team in planning, conduct, and closeout of assigned clinical studies with a focus on assuring quality and consistency in site management and clinical monitoring activities across regions, and compliance with GCP/ICH and study objectives.
Essential Functions
-Assists in the development and review of clinical study documents including informed consent forms, source document worksheets, study manuals, and operational plans
-Supports site selection and activation, essential document collection, clinical supply management and tracking, and negotiating study budgets
-Provides oversight to assigned vendors which may include central lab, central imaging, central IRB, electronic data capture, and CROs
-Provides oversight of clinical monitoring and site management activities including document management, study training, support of field CRAs, safety reporting, and monitoring visit report review
-Conduct co-monitoring/quality assessment visits with field CRAs to ensure quality of clinical monitoring, site compliance and quality, and to provide training as needed. May also directly conduct site qualification and initiation visits
-May act as a study un blinded CRA to oversee un blinded field CRA team, investigational product inventory management, and site management issues
Join Aerotek Scientific®LLC, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, were constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know its more than just your day-to-day responsibilities that can make or break a job. Its the support you get. Thats the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Dont put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law. Requirements
- Clin Rsrch Monitor - Uncatgrzd, GCP/ICH, STUDY MONITORING, Central IRB
Country: USA, State: Washington, City: Seattle, Company: Aerotek.
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