• Acts as primary site contact and site manager for all operational and routine protocol issues in support of clinical research studies. Communicates with sites on issues related to protocol conduct, enrollment/retention, protocol deviations, regulatory documentation, site audits/inspections, overall site performance, and financial payments.
• Performs on-site monitoring visits, ensuring site compliance with protocol, ICH, GCP, MSD global standards, local laws and regulations, including but not limited to review of informed consent, AE/SAEs, Health Authority documentation, and IMP supplies. Performs source document verification of subject data and query resolution. Coordinate receipt and distribution of clinical trial supplies
• Provides input to Site Selection utilizing site evaluation and validation processes.
• Maintains accurate study site information in the CTMS and records visit and non-visit contacts appropriately and in a timely manner. Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Manages a full complement of sites with multiple protocols, depending on study/site complexity. Discusses the need for escalation of site performance issues with CRM, and supports audit/inspection activities as needed.
• Medical qualifications, bachelor degree or above in Clinical Medicine, Pharmacology and Public Health, etc., strong emphasis in science
• Above 1 year clinical research preferred experience 1 year of which should be site management experience.
• Proficiency in computer skills
• Result oriented
• Teamwork spirit and cooperation skills
• Customer focus
• Good communication skill
• Proactive and self-motivated