AstraZeneca Pharmaceuticals LP Clinical Research Associate in Delaware
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.
The Monitor has local responsibility for the delivery of the studies at allocated centers and are active participants in the local study team(s). The Monitor works 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 Monitor 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 Monitor with longer tenure and experience may take on additional responsibilities that include additional tasks associated with Lead CRA, Senior CRA and/or Site Liaison.
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).
Additional Responsibilities May Include
Ensure completeness of the Study Master File and ensure essential documents are sent to R&D site.
Ensure timely delivery of proper applications/documents for submission to Regulatory Authorities.
Ensure timely customization and completion of the CSA for designated studies
Design draft budget for designated studies according to fSMA requirements
Track and manage agreed payments at study site level.
Participate in training and mentoring of new members of the local Study Delivery Team ensuring compliance with ICH/GCP and AZ Procedural documents.
Ensure 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.
Minimum Requirements and Preferred Background
Bachelor’s 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 as required, 50-70%.
Next Steps – Apply today!
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.