Clinical Research Associate – 12 Month Contract

Role Overview

• Contributes to the selection of potential investigators
• In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance
• Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study
• Trains, supports and advises Investigators and site staff in study-related matters, including Risk Based Quality Management (RbQM) principles
• Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study
• Ensures the sites are inspection ready at all times
• Actively participates in Local Study Team (LST) meetings
• Contributes to National Investigators meetings, as applicable
• Initiates, monitors and closes study sites in compliance with AZ Procedural Documents
• Shares information on patient recruitment and study site progress (site quality/performance) within the LST
• Drives performance at the sites
• Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate
• Updates CTMS and other systems with data from study sites as per required timelines
• Manages study supplies (ISF, etc), drug supplies and drug accountability at study site
• Prepares study drug for destruction, if applicable
• Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study-specific Monitoring Plan
• If required, determines and discusses with LSAD the correct timing and type of visits
• Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan
• Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study
• Ensures data query resolution in a timely manner
• Works with data management to ensure robust quality of the collected study data
• Ensures accurate and timely reporting of Serious Adverse Events and their follow-ups
• Prepares and finalises monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with AZ SOP
• Follows up on outstanding actions with study sites to ensure resolution in a timely manner
• Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues to Local Management and/or CQM as required
• Assists site in maintaining inspection-ready ISF
• Prepares for and collaborates with activities associated with audits and regulatory inspections in liaison with LSAD and CQAD
• Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs and local requirements
• Supports/participates in regular QC checks performed by LSAD or delegate
• Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF
• Provides feedback on any research-related information including sites/investigators/competing studies that might be useful for the local market
• Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment)
• Ensures compliance with local, national and regional legislation, as applicable
• Collaborates with local MSLs as directed by LSAD or line manager

Requirements

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification
• Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
• Good knowledge of relevant local regulations
• Good medical knowledge and ability to learn 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
• Excellent attention to details
• Good written and verbal communication skills
• Good collaboration and interpersonal skills
• Good negotiation skills
• Ability to travel nationally/internationally as required
• Valid G driving license

Tech Stack

• Google Cloud Platform

Benefits

• competitive Flex Benefits & Retirement Savings Program
• 4 weeks’ paid vacation
• annual Personal Days