Gail Catulin

Detail-oriented CRA with 3+ years across remote monitoring, on-site visits, and regulatory submissions. Skilled in SDV, AE/SAE oversight, eTMF management, and multi-protocol compliance. Proven ability to drive site quality and ensure GCP adherence across treatment and vaccine trials.

Clinical Quality Control Specialist II - One CoreDev IT - Makati City, Philippines

(2024-07 - 2024-09)

• Conducted remote monitoring of ICF, HIPAA, lab reports, and source documents across screening to end-of-study visits
• Verified accuracy and completeness of CRIO data entries and uploaded source documents across multiple treatment and vaccine protocols
• Ensured proper documentation, reporting, and follow-up of AEs/SAEs while tracking and auditing all identified protocol deviations

Clinical Research Associate (Fixed-term) - Novotech Ltd-Philippine Branch - Mandaluyong City, Philippines

(2023-04 - 2024-04)

• Executed on-site monitoring visits with full SDV, protocol deviation identification, and regulatory reporting to sponsors and IRB
• Served as primary site contact across ongoing studies, managing ISF maintenance, Veeva uploads, and CTMS tracker updates
• Prepared confirmation letters, follow-up letters, and monitoring reports; coordinated AE/SAE reconciliations and query resolution with data management

In-house Clinical Research Associate - Novotech Ltd-Philippine Branch - Mandaluyong City, Philippines

(2022-12 - 2023-03)

• Maintained eTMF (Veeva Vault) completeness, supported IRB/PFDA submissions, and tracked site compliance for audit readiness
• Reviewed site invoices per CTRA, assisted investigator and vendor payments, and managed procurement of study materials
• Assisted CRAs in CTMS subject visit tracking and QC of regulatory documents prior to submission

Junior Clinical Research Associate (Project-based) - Pharmalytics Corporation - General Trias City, Cavite

(2021-10 - 2022-09)

• Supported site feasibility, Ethics/FDA submissions, site initiation visits, and acted as primary site contact across bioequivalence studies

Molecular Biologist - Globetek Science Foundation - Makati City, Metro Manila

(2021-05 - 2021-09)

• Executed molecular biology experiments including PCR, RT-qPCR, gene cloning, and cell line maintenance; delivered weekly data analysis reports

Research Intern - National Pingtung University of Science and Technology - Pingtung Country, Taiwan

(2019-11 - 2020-06)

• Conducted PCR, SDS-PAGE, Western Blot, and DNA extraction for avian research; co-authored published research journals and review papers

B.S. - Biological Engineering - Mapua University (2014 - 2021)

Secondary Education - Peñablanca National High School (2007 - 2012)