[Biopharma]Clinical Research Associate

[Role Description]
The Clinical Research Associate (CRA) has local responsibility for the delivery of 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 Associate Director (LSAD) 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. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. They must ensure that the sites deliver according to their respective commitment in the individual studies. A CRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD.

[Typical Accountabilities]

• Contributes to the selection of potential investigators.
• 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 on study-related matters, including Risk-Based Quality Management (RbQM) principles.
• Confirms that site staff have completed and documented the required training 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 Investigator 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 of 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 sites. Prepares study drugs 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 finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letters, 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 the site in maintaining an 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 the 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.

[Skills]

• Good written and verbal communication skills.
• Good collaboration and interpersonal skills.
• Good negotiation skills.

[Qualifications]

• Education: Bachelor's degree in a related discipline, preferably in life science, or equivalent qualification.
• Language: Korean, English.
• Work Experience: CRA
• Competencies:
  • Excellent knowledge of international guidelines (ICH-GCP), basic knowledge of GMP/GDP.
  • Good knowledge of relevant local regulations.
  • Good medical knowledge and the 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 detail.