BS Biological Engineering
Mapua University
N/a
Mapua University
• Monitoring of subject’s chart from screening visit to end of study visit
• Review of all study procedures to ensure that these are conducted according to study protocol, Good Clinical Practice (GCP), and other regulatory requirement
• Ensuring complete documentation and all uploaded sources are correct, signed, and dated
• Ensuring accurate and complete data are entered in CRIO
• Review of different study protocols of treatment and vaccine trial
• Coordinate with clinical research site study team for any queries and issues noted and ensuring these issues are addressed
• Ensuring that any AEs or SAEs noted are properly documented and unresolved AEs are followed up by the clinical sites
• Reporting any significant clinical issues identified to superiors and discussing resolution
• Ensuring all PD identified issues are properly reported and correspondence is available to justify any missing procedure or visit
• Properly tracking of issues identified and audited charts
• Assisted CRAs in maintaining completeness and accuracy of all documents available in eTMF (Veeva Vault) including filing and uploading of documents
• Assisted CRAs in tracking subject visits in CTMS
• Assisted in reviewing/QC of printed documents, ensuring completeness of documents prior submission to IRB
• Assisted in reviewing regulatory documents prior submission to PFDA and tracking for site compliance and audit readiness
• Reviewed site invoices according to CTRA, assisted in investigator and vendor payments, and tracking of all invoices
• Responsible for procurement of study materials, managing and ensuring the materials are of good quality
• Participated in pre-site initiation visits/site feasibility
• Responsible for executing/following-up meetings/trainings with possible sites, investigators, and study staff
• Assisted in preparing and documenting Ethics and FDA submissions
• Responsible for preparation and participation in information dissemination of the project for each Barangay Health Centers, City/Municipal Health Office of the functional area for recruitment
• Acted as primary contact for the assigned site
• Conducted preparations for activities such as site initiation visit
• Ensured the completeness of documents and supplies for assigned site
• Participated in Bioequivalence/Bioanalytical studies
Analyzing engagement data, identifying trends in customer interaction and planning digital campaigns to build community.
Search the Internet for information on a wide variety of topics.
Scheduling appointments, handling correspondence, and managing records.