AstraZeneca contributes meaningfully to the UK beyond the provision of our medicines and the benefits they provide to the health of the nation. We commissioned a report in 2009 to measure our significant investment to the UK economy, which includes investment in jobs and wealth creation. Oxera, an independent economic consultancy provided the analysis for this report.
Post : Clinical Research Associate
Job Description
The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Manager to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study
Key Duties and Accountabilities
• 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 advice 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 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 by the site.
• Ensure accurate and timely reporting of Serious Adverse Events by the site.
• 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).
• 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 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.
• Actively share applicable information that may be relevant to Marketing & Sales and the MC Medical Department and in accordance with Corporate.
Candidate Profile
• At least one year experience in global phase 2/3 clinical trial monitoring.
• Qualified as a pharmacist, physician or a dentist.
• Data driven, highly scientifically oriented person.
• Prior experience as a CRA/Sr. CRA in a multinational pharmaceutical company or a multinational CRO. Currently responsible for on-site monitoring of phase 2/3 global clinical studies. Candidates from remote monitoring background will not be considered even if they have previous on-site monitoring experience.
• Passion for delivery and absolutely non-compromising attitude towards quality.
• Excellent communication skills, and passion to redefine the quality and efficiency standards.
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
• Ability to work in an environment of remote collaborators
• Good analytical and problem-solving skills.
• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
Additional Information
Experience : one year experience
Qualification : Qualified as a pharmacist
Location : Delhi
Functional Area : Clinical Research
End Date : 30-Dec-2023
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