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.