Clinical Research Associate

Typical Accountabilities

• Be accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification, collection, preparation, review and tracking of documents for the application process; submission of proper 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 time Actively participates in Local Study Team (LST) meetings.
• 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 Clinical Trial Management System 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.
• Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan.
• 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 and 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 finalizes monitoring visit reports and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with AZ SOP.
• Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, protocol or ICH-GCP compliance issues to Local Management and/or CQM as required.
• Prepares for and collaborates with the 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.
• Collaborates with local MSLs as directed by LSAD or line manager.
• A CRA with longer experience may have a development opportunity to take on additional responsibilities that include tasks associated with Local Study Associate Director.**

Qualification:

• Bachelor degree in related discipline, preferably in life science, or equivalent.
• 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 about Oncology area.
• Good understanding of Clinical Study Management including monitoring, study drug handling and data management. Minimum 1-2 years experiences in global clinical trials monitoring would be advantage. More experiences may be considered senior position.
• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
• Good attention to details and critical-thinking skill
• Good written and verbal communication skills (English and Thai)
• Good collaboration and interpersonal skill
• Manages change with a positive approach for self, team and the business.
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
• Ability to travel nationally/internationally as required.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.