Clinical Research Associate II at Burlington

Job Description

Job Classification: Direct Hire Our client, an established cardiac medical device sponsor company, is seeking a CRA II for their trials based out of Burlington, MA. Ideal candidates will have 2+ years independent monitoring experience, medical device experience, strong regulatory knowledge and a desire to work directly with a sponsor company in an in-house role.The Clinical Research Associate II will be responsible for performing clinical monitoring visits including site qualification, site initiation, interim monitoring visits and study close-out visits. Responsible for the oversight and training of study site personnel to ensure adherence to the protocol and investigational plan, data integrity, accurate source documentation, compliance and adherence to local, FDA GCP/ICH requirements and where applicable, international regulatory requirements, and accurate storage and disposition of investigation product and study supplies. This position reports into Clinical Affairs Management- Organizes, monitors, implements and reports clinical study progress to the clinical management team as required.- Collects, reviews, verifies and summarizes patient data from study sites. Serves as primary contact to sites on study related questions. Troubleshoots complex study and data related issues.- Independently oversees Contract/Regional Clinical Monitors and reports progress and/or risk to Clinical Management/Program Manager.- Travels to clinical sites to initiate, monitor compliance and perform closeout visits for clinical studies.- Periodic monitoring of protocol pager for urgent site/subject related issues.- Assists the Clinical Manager/Clinical Program Manager with the development of formal clinical summaries and reports for the writing of regulatory submission documents.- Frequent travel, including occasional international travel, is required (up to 50%). 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.

Job Requirements

• CRA Monitor, medical device

Country: USA, State: Massachusetts, City: Burlington, Company: Aerotek.