Note: The job is a remote job and is open to candidates in USA. PanaCRO is a contract research organization specializing in pharmaceutical R&D and clinical studies. They are seeking a Senior Clinical Research Associate to oversee and manage all aspects of clinical trials, ensuring compliance with GCP and SOP, and maintaining positive relationships with sites and investigators.
Responsibilities
- Overseeing the management and administration of all aspects of clinical trials/studies involved in each step of the clinical study
- Preparing protocols and other necessary documents required for trial approval by EC and get EC approval on time
- Monitoring and coordinating the clinical trial conduction in whole process by following GCP and SOP strictly
- Giving input to query resolution, site closure and collection of documentation required for clinical trial reports after trial end
- Ensuring EDC/CTMS system is updated in a timely and accurate manner in accordance with requirements
- Ensuring all SAEs/adverse drug reactions are reported and followed up in a timely manner according to internal relevant SOP
- Update investigator file and trial master file
- Build and maintain positive relationships with the site and investigators
- Ensure site visit reports and correspondence is completed in time
Skills
- Bachelor degree in biomedical/science discipline or equivalent (e.g. BSc, Registered Nurse, BPharm)
- At least 3-10 years clinical operation monitor experience for senior position
- Fluent English
- Good communication and organization skills
- Good and proactive working attitude
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