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Clinical Research Associate (CRA)
Posted Feb 8, 2021
- Obtain and maintain essential documentation in compliance with ICH-GCP, AZ procedural documents and local regulations both in trial master file (TMF) and investigator study file (ISF).
- 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.
- 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 team.
- Drive performance at the sites. Proactively identify study-related issues, solutions and escalate as appropriate.
- Update CTMS and other systems with data from centers 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.
- Oversee data query resolution by the site.
- Verify 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 CQM.
- Provide the required monitoring visit reports within required timelines.
- Work with data management to confirm quality of the study data.
- Support and work together with lead CRA, LSM and regulatory affairs to see to timely delivery of study documents for submissions to RA and EC.
- Contribute to financial agreements with relevant staff at investigational site in collaboration with lead CRA and/or LSM.
- Oversee timely preparation of country specific CSA in collaboration with LSM and/or lead CRA.
- Verify compliance with AZ’s code of conduct and company policies and procedures relating to people, finance, technology, security and safety, health and environment.
- Track and manage agreed payments at study site level.
- Participate in training and mentoring of new members of the local study team verifying compliance with ICH/GCP and AZ procedural documents.
- Confirm that all study documents are ready for final archiving and sign-off completion of local part of the trial master file.
- Contribute to process improvements, knowledge transfer and best practice sharing.
- Actively share applicable information that may be relevant to marketing and sales and the MC medical department and in accordance with corporate ethical guidelines.