Recruitment for Clinical Research Associate in the AstraZeneca
- 2017-08-17
Recruitment for Clinical Research Associate in the AstraZeneca
The Clinical Research Associate(CRA) has the local responsibility for the delivery of the studies at allocated centers and are active participants in the local study team(s). You’ll work in close collaboration with other Monitors and the Local Study Delivery Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner.
The CRA is responsible for the preparation, initiation, monitoring and closure of an agreed number of centres in clinical studies according to AZ Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations. Deliver according to the commitment in the individual trials.
A CRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with Lead CRA, Senior CRA, Local Study Team Leader(LSTL).
[Major responsibilities]
- 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 CA&A.
- 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).
[Minimum Requirements and Preferred Background]
- University degree in related discipline, preferably in life science, or equivalent qualification.
- Fluent knowledge of spoken and written English.
- Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
- Good knowledge of relevant local regulations.
- Good medical knowledge in relevant AZ Therapeutic Areas.
- Basic understanding of the drug development process.
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
- Ability to travel nationally as required.
If you wish to support, please go through the link below.
https://job-search.astrazeneca.com/search-jobs/CRA/7684/1