Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents and local regulations both in the office and at site.
Actively participate in local Study Delivery Team meetings.
Contribute to the selection of potential investigators.
Train, support and advise Investigators and site staff in study related matters.
Contribute to national Investigators meetings.
Initiate monitor and close study sites in compliance with AZ Procedural Documents. Share information on patient recruitment and study site progress within local Study Delivery Team.
Drive performance at the sites. Proactively identify study-related issues and escalates as appropriate.
Update IMPACT and other systems with data from centres as per required timelines.
Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.
Perform source data verification according to SDV plan.
Ensure data query resolution.
Ensure accurate and timely reporting of Serious Adverse Events.
Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA.
Provide the required monitoring visit reports within required timelines.
Work with data management to ensure quality of the study data.
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).
