Clinical Research Associate Jobs

CRA will be primarily responsible for ensuring site compliance with specified research protocols and the accuracy of submitted data. This role demands maintaining proper written documentation for the study records of all site interactions

Responsibilities

• Conduct all aspects of monitoring of a clinical trial according to ICH GCP requirements including on-site Pre-Study Visits (PSVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs), Remote monitoring and other aspects of site support, trial documentation, maintaining the Trial Master File (TMF), liaison with sites and reporting to the trial sponsor.
• Support study start-up activities including site selection, collecting essential documents and CTRA, register study on ANZCTR.
• You may need to travel interstate for site visits or conduct on site monitoring visits locally if you are in a regional position.
• You will also manage regular site liaison, tracking, query resolution, and maintaining investigator site file and TMF.
• You may write the monitoring plan and check manuals that will be used at the study site.

Qualifications

• A graduate or post-graduate with science &/or medical &/or pharmaceutical back ground.
• Diploma &/or degree in Clinical Research

REQUIRED EXPERIENCE

• Great and consistent attention to detail and follow through on commitments.
• Approximately 3-5yr Experience as Clinical Research Associate
• Fundamental knowledge and good understanding of GCP’s, clinical study development process, and logistics.

REQUIRED SKILL SETS

• Proficient knowledge of MS Office Applications (Word, Excel, PowerPoint, Etc.
• Excellent interpersonal, judgment, and time management