Shelly Heredia, MD

Physician and board-certified Internist (Philippines) with 6+ years of clinical experience and 2+ years in U.S.-based clinical research. Experienced in safety data evaluation, adverse event assessment, protocol interpretation, and clinical data review across ~15 clinical trials. Targeting Medical Monitor / Medical Reviewer roles within sponsor or CRO environments, contributing to patient safety oversight, clinical data evaluation, and protocol integrity.

• English, Fluent
• Tagalog, Fluent
• Spanish, Intermediate

• Good Clinical Practice – ICH E6(R3), Advarra, 01/01/25
• Good Clinical Practice TransCelerate Approved – ICH E6 (R2), Clinical Research Fastrack, 01/01/24
• Clinical Research Fastrack, 02/01/24, 04/30/24, Training in ICH-GCP, FDA regulations, protocol execution, and safety reporting.
• Good Clinical Practice for Research, Manila, Philippines, 2020
• Diplomate, Philippine College of Physicians, 2020
• Philippine Specialty Board of Internal Medicine, 2020
• Philippine Medical Licensure Examination, 2016
• Philippine Nursing Licensure Examination, 2010

• Clinical Research Coordinator, Clinical Research of South Nevada, 04/01/24, Present, Supported ~15 clinical trials (7 closed; 8 ongoing) with strong involvement and high degree of independence in safety review, protocol implementation, and clinical data evaluation., Medical review of subject eligibility, including medical history, concomitant medications, and laboratory data., Evaluation and reporting of AEs/SAEs, ensuring clinical accuracy, completeness, and timeliness., Contribute to safety data review and sponsor/CRO query resolution with medically informed input., Apply clinical judgment in protocol interpretation, subject screening, and study participation decisions., Assess clinical significance of abnormal labs, vital signs, and emerging safety concerns., Support protocol compliance and deviation assessment in accordance with ICH-GCP., Serve as liaison for sponsor, CRO, and medical monitor communications., Draft medical query responses and support investigator decisions under PI oversight., Maintain audit-ready regulatory documentation and support monitoring visits/audits.
• Science Research Specialist II, University of the Philippines - National Institutes of Health, 01/01/21, 12/31/22, Manila, Philippines, Co-authored randomized controlled trial on COVID-19 treatment., Conducted clinical data analysis, interpretation, and manuscript development., Supported enrollment and monitoring of 275+ subjects across Phase I–II trials.