Operate as main point of contact for the site during the study (primary investigator interaction for all GCP and data-related activities, all on-site tools, and materials and logistics needed to carry out the study)
Perform routine monitoring visits and ensure GCP compliance by ensuring all subjects have signed and dated all required current approved informed consents and privacy forms as applicable as well as verifying all subjects meet inclusion and exclusion criteria
Ensure site completion and accuracy of regulatory documents by working closely with Regulatory Operations Specialists or equivalent in the country/region
Monitor safety at the site, complete Site Closeout and ensure inspection readiness
Conduct Site Initiation Visit (SIV)/complete site training and knowledge transfer
Write Trip Reports by capturing all medical and operational issues in accordance with standard operating procedures and monitoring plan, sending follow up letters to site and taking accountability for resolving documented issues until all issues are closed
Ensure clinical and drug supplies are received at the site in good condition
Drive and execute monitoring plan and study timelines at assigned sites
Maintain communication log by appropriately recording all significant communications with site, study team, and operation specialists as well as providing Study Team/Regional Study Manager updates on issues and risks on a site per site basis
Participate in additional study and site activities including Regional Study Manager roles and activities when requested
Qualification
:
University Degree in Pharmaceutical Science, Clinical, Life Sciences, Nursing or other related fields
Minimum 3-year experience as Clinical Research Associate with strong project management skill
Thorough understanding of the investigational product(s), the protocol, written informed consent, relevant SOPs, GCP, data privacy laws and applicable regulatory requirements
Creative solution thinking, able to prioritize and being decisive
Being able to work independently and adhere to deadlines
Attentive to details, adaptive and flexible
Proactive, action-oriented and results-driven
Good communication and presentation skills in both Thai and English language
Good computer skills in Microsoft Word, Excel and PowerPoint and relevant software packages
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Senior Clinical Research Associate 
