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The Clinical Research Associate (CRA) is responsible for managing and monitoring the conduct of clinical projects according to ICH-GCP, Standard Operating Procedures (SOP) and applicable Project Management Plan (PMP) and local regulatory requirements.
Responsibilities:
Contribute comments/input in the development of Protocol, Informed Consent Form (ICF), Case Report Forms (CRF) and other project related documents.
Evaluation potential sites with the assistance from the senior CRA, PM or line manager and provide PM with recommendations for selection of qualified sites.
Prepare the package for institutional review boards (IRB) and local regulatory authority submissions and obtain IRB/regulatory approvals for conducting the clinical trial.
Assist PM in start-up meeting.
Prepare and manage the clinical trial agreements with investigators/sites.
Track, manage and control the site budget and expenses within approved budget and in line with the project milestones as requested.
Manage/coordinate the investigational products and clinical trial materials for the sites in compliance with regulatory requirements.
Monitor and report the project status at the sites in a timely manner.
Key contact person for the communication between the sites and study team.
Prepare, arrange and conduct the training of site personnel.
Conduct site initiation, monitoring and site close-out visits in compliance with monitoring plan, ICH-GCP, SOPs, local regulations and other applicable project-specific plans.
Prepare monitoring report according to the SOP.
Assist the investigator for auditing/inspection of project.
Coordinate with the sites to ensure all adverse events and follow-up are appropriately reported and reconciled according to regulations.
Identify, analyze and resolve the issues at the investigator sites.
Qualifications:
BS (Bachelor of Science) degree or equivalence experience. Advanced degree is a plus.
At least 3 years experience in clinical research environment.
Good ability of written and spoken in English.
Good organization and communication skills.
High attention to detail and accuracy.