Clinical Research Associate At AstraZeneca
The mission of Clinical Research Associate is to provide solutions to improve the quality of patients' Lives. You will be able to lead all sales activities in the assigned territory. It's a role that will involve collaborating with sales team to provide the best possible results and gaining wide scope of experiences. If you are inspired by the different possibilities to make a difference in patients' lives, Join Us
CRA Major Accountabilities :-
Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents and local regulations both in the office and at site. Ensure completeness of the Trial Master File.
Actively participate in local Study Team meetings.
Contribute to the selection of potential investigators, train, support and advise Investigators and site staff in study related matters.
Initiate, monitor and close study sites in compliance with AZ Procedural Documents. Share information on patient recruitment and study site progress within local Study Team.
Drive performance at the sites. Proactively identify study-related issues and ensure query resolution.
Update Clinical Trial Management System data from centers as per required timelines.
Manage study supplies (ISF, CRF, etc), at study sites.
Perform source data verification and source data review per SDV plan.
Ensure accurate and timely reporting of Serious Adverse Events.
Provide the required monitoring visit reports within required timelines (remote or on site visits).
Work with sites and data management to ensure quality of the study data and early data entry.
Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
Tracking of study budget and payments.
Prepare submission Packages for IRB/IEC and Regulatory Authorities.