Study Management Associate
Posted: November 25, 2016
Reference ID: 1073452962
A Study Management Associate job in Irvine,CA needs to be filled immediately by Adecco Medical & Science. This is a 1 year in-house opportunity. Adecco Medical & Science is a division of the world leader in medical and scientific professional recruiting.
Study Management Associate responsibilities:
•Ensure all site related activities and files are completed per the SOPs.
•Serve as key point of contact for study specific questions from both internal (eg, site monitors, clinical services specialist) and external (eg, site personnel, vendors) customers.
•Review clinical data through monitoring reports and data listings in order to monitor overall clinical data quality and identify and resolve potential study or site issues as appropriate.
•Set up, test, review, and update clinical systems (eg, CTMS) and tracking tools.
•Collect and track study specific data and producing clinical status, trend, and metric reports to assist the manager in proactive study management and contingency planning.
•Oversee the logistical tasks associated with the preparation, collection, review and tracking of the master and site non-regulatory file documents.
• Bachelor's degree and 2-3 years of experience working with sponsors or CRO
• Monitoring experience is desirable.
• Knowledge of Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics.
• Familiarity with HIPAA and patient privacy laws.
• Knowledge of concepts of clinical research and drug development, and general therapeutic area education and training.
If you are interested in this Study Management Associate job in Irvine, CA then please click APPLY NOW. For other opportunities available at Adecco Medical and Science go to www.adeccousa.com or email your resume to Melody.Lam@adeccona.com
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