Senior Clinical Research Associate - Dexcom Philippines, Inc.
(2024-05)
- Partner with Clinical Affairs leadership to support the design, planning, and execution of medical device clinical studies in alignment with study protocols, GCP, ICH guidelines, and Dexcom SOPs.
- Independently manage assigned clinical trials across the full study lifecycle, including study start-up, subject recruitment and scheduling, informed consent, screening, subject training, and conduct of study visits.
- Perform and oversee study procedures including SMBG testing, device accountability, regulatory documentation, timely data entry, query resolution, and accurate reporting of adverse events (AEs), serious adverse events (SAEs), and protocol deviations.
- Proactively identify, assess, and escalate safety events, significant protocol deviations, and study risks to Clinical Affairs management, contributing to patient safety and trial integrity.
- Prepare, track, and account for investigational devices and study supplies required for clinical execution.
- Contribute to protocol development and review in collaboration with Clinical Affairs management and cross-functional stakeholders, ensuring alignment with study objectives and critical data endpoints.
- Develop and review clinical study materials, including source documents, CRFs, IRB submissions, investigator training materials, and site-facing documentation.
- Collaborate closely with project management to establish, maintain, and execute study timelines, effectively prioritizing clinical tasks and deliverables to meet milestones.
- Coordinate daily study operations, including workflow optimization, implementation of study procedures, and site support.
- Support preparation and submission of essential documents to Institutional Review Boards (IRBs), including study start-up, amendments, and close-out.
- Assist Clinical Affairs management during internal audits and inspections by supporting documentation review and procedural compliance.
- Build and maintain effective professional relationships with cross-functional teams, Regulatory Authorities, IRBs, and key opinion leaders.
Central Monitor I - Syneos Health
(2021-07 - 2024-05)
- Perform remote patient data review activities for Phase I-IV clinical research and/or noninterventional studies (NIS) to assess compliance with the protocol, ICH-GCP, and/or all applicable local and federal regulatory requirements.
- Understands the Clinical Monitoring Plan (CMP), Protocol, Therapeutic Indication and Monitoring Strategy specific to assigned study(ies).
- Conducts subject and site-level central monitoring activities as per the CMP. Activities include Central Monitoring Clinical Review (CMCR), Key Risk Indicator (KRI) Review, and Site Central Assessment Notification (SCAN).
- Ability to synthesize data trends, issues, and action items in a clear and concise presentation of the most relevant and actionable items for interpretation by CRAs and other functional roles assigned follow-up.
- Ensures patient safety and data integrity through the review of patient data listings, systems, and visualizations via analytical dashboards and/or reports.
- Emphases data review for informed consent, subject eligibility, AEs/SAEs/SADEs/DDs and associated documentation, safety reporting, critical data issues and trends, significant errors or data integrity risks and trends, site process issues, subject level deviations/site level non-compliances, action items, data queries, and IP.
- Documents observations noted during reviews and issues queries, create action items, and records protocol deviations in appropriate systems for action by sites, CRAs or other functional team members.
- Review CMCR query responses and associated actions entered in the EDC by site personnel to confirm appropriate response/closure.
- Assess site data quality, risks and trends as well as operational performance and summarize the findings for CRA review and action planning.
- Follows escalation pathways as per the CMP if a finding noted during Central Monitoring activities is considered to have a significant impact on subject safety, data integrity or regulatory compliance.
Medical Technologist/Med.tech Coordinator - Tropical Disease Foundation – Medical Research Unit
(2020-10 - 2021-07)
- Ensured laboratory operations complied with clinical trial protocols, GCP guidelines, regulatory requirements, and internal SOPs.
- Coordinated and supported clinical trial activities, including sample handling, documentation, and shipment, while maintaining cold chain integrity.
- Oversaw equipment maintenance and reported issues promptly to ensure uninterrupted lab functionality.
- Maintained high standards of safety and quality in sample collection and processing.
- Conducted quality control checks and ensured accuracy of laboratory data.
- Managed inventory and ordered supplies to prevent shortages.
- Trained and supervised newly hired medical technologists, ensuring adherence to lab protocols and quality standards.
- Participated in protocol reviews and resolved discrepancies related to laboratory procedures.
- Maintained confidentiality and accuracy in subject records and documentation.
Medical Technologist/Med.tech Coordinator - Research Institute for Tropical Medicine (RITM)
(2011-05 - 2020-10)
- Ensured laboratory operations complied with clinical trial protocols, GCP guidelines, regulatory requirements, and internal SOPs.
- Coordinated and supported clinical trial activities, including sample handling, documentation, and shipment, while maintaining cold chain integrity.
- Oversaw equipment maintenance and reported issues promptly to ensure uninterrupted lab functionality.
- Maintained high standards of safety and quality in sample collection and processing.
- Conducted quality control checks and ensured accuracy of laboratory data.
- Managed inventory and ordered supplies to prevent shortages.
- Trained and supervised newly hired medical technologists, ensuring adherence to lab protocols and quality standards.
- Participated in protocol reviews and resolved discrepancies related to laboratory procedures.
- Maintained confidentiality and accuracy in subject records and documentation.
Medical Technologist - Our Lady of the Pillar Medical Center
(2009-11 - 2011-01)
- Assisted the Chief Medical Technologist in supervising laboratory operations.
- Reported to the laboratory on time and rendered overtime duty when necessary.
- Completed all laboratory requests promptly and ensured proper endorsement to the next shift.
- Monitored reagent consumption and submitted monthly reports for the assigned section.
- Maintained cleanliness, discipline, and cooperation within the laboratory.
- Received and processed laboratory requests and specimens from inpatients and outpatients, including proper charging.
- Provided patients with instructions for laboratory examination preparation.
- Collected specimens for the Clinical Chemistry Section.
- Performed blood chemistry tests including Fasting Blood Sugar, BUN, Uric Acid, Creatinine, Lipid Profile, Liver Profile, Amylase, Acid Phosphatase, Electrolytes (Na, K, Cl, Ca), and 24-hour urine tests (Creatinine, Total Protein, etc.).
- Conducted hematological tests such as CBC, Platelet Count, Reticulocyte Count, Malarial Smear, Toxic Granulation, ESR, Clotting Time, and Bleeding Time.
- Performed routine urine tests, pregnancy tests, stool exams (ova/parasite), and occult blood tests.
- Conducted serological tests including ABO and Rh Typing, Typhidot, Widal Test, HBsAg Screening, VDRL/RPR, HIV, and others.
- Screened donor compatibility and performed crossmatching (Major, Minor, Albumin Phase, Anti-Human Phase, Thermal Phase), Coombs Test (Direct and Indirect), ABO Typing, and Back Typing.
- Processed donor blood into Fresh Whole Blood and Packed RBC.
- Performed bacteriological tests including Culture and Sensitivity of urine, stool, sputum, vaginal/urethral discharge, pleural fluid, throat swab, abscess, ear/nose discharge.
- Examined smears using Gram Stain and Acid-Fast Bacilli Stain; prepared culture media and reagents.
- Received and recorded specimens; assisted the Pathologist during CT-guided procedures and cytology slide preparation (Papanicolaou stain).
- Conducted body fluid analysis (CSF, Pleural Fluid, Synovial Fluid) including cell counts, differential counts, sugar, protein, and chloride levels.
- Performed semen analysis including sperm count, liquefaction time, motility, and morphology.
- Released laboratory results on time.
- Maintained confidentiality and accuracy in subject records and documentation.
Phlebotomist - Our Lady of the Pillar Medical Center
(2007-11 - 2008-07)
- Performed venipuncture and capillary blood collection (finger stick and heel stick) for both in‑patients and out‑patients.
- Processed and documented laboratory results for in‑patient and out‑patient testing in a timely and accurate manner.
- Maintained patient records and prepared, updated, and organized laboratory reports and procedure manuals.
- Collected throat culture and other required specimens in accordance with laboratory protocols.
- Provided clear instructions to patients regarding proper specimen collection procedures.
- Maintained a clean, safe, and organized laboratory work environment, including routine cleaning of laboratory glassware.
