Isolter Leon-Romero Email & Phone Number

Bethesda, Maryland, United States

• Configures studies for pharmacovigilance in Oracle Argus Safety Console, incorporating protocol and client requirements in code lists, studies, and memorized reports.• Analyzes Data Management Center and client data formats (Line Listings) for Oracle Argus compatibility and manual data entry usability.• Manages client business needs and expectations driving the dialog with Information Technology (IT) for implementing Oracle Argus tenants, studies, and reports.• Evaluates and EAE reports received from clinical sites, including preparing Safety Reports per project and regulatory guidelines.• Collects accurate information from the site and enters necessary information into the DAIDS Adverse Event Reporting System (DAERS).• Reviews experimental protocols (100+) and safety information from DAIDS, the Division of Microbiology and Infectious Diseases (DMID), and NCI Phase 1 and 2 studies.• Produces complex safety report from Statistical Analysis System (SAS) for investigational product analysis and signal detection.• Analyzes medical research data and then summarizes safety data into chronologically, well- thought-out, detailed case narratives. Responds to email or phone queries on case-specific issues.• Instructs and prepares other staff, across multiple projects, for data entry, report creation, protocol abstraction, and study configuration in Oracle Argus Safety.

Guanajuato, Mexico

• Implemented public policies for service quality and patient safety in the state hospitals and clinics• Managed patient safety, clinical guidelines adherence and health provider accreditation programs• In charge of local health provider quality liaison relationships and collection of individual program information to assemble quarterly and annual reports• Supervised service quality, policy adherence and program strategy implementation in state-run hospitals and clinics

Durango, México

• Directed a staff of 10 adjunct professors and lecturers teaching core science courses• Taught diverse subjects to classes of up to 40 students including pharmacology, immunology, physiology, biochemistry and medical English

Durango, Mexico

• Conducted phase III clinical trials for major industry sponsors (Endocrinology and Rheumatology)• In charge of drug safety, SAE reporting, SAE processing, narrative writing, medical review, lab and diagnostics test review, safety report submissions• Authored or co-authored clinical SOPs and prepared regulatory documentation for submission, routinely completed eCRFs• Experience with ClinPhone, DrugDev Spark, eSite, iMedidata and Perceptive my Trials Clinical Research Management systems• Reviewed ICFs and MOPs for plain language and clarity to train pharmacists, nurses and other allied staff• Responsible for executing various study roles and activities including: patient recruitment, informed consent, clinical history, screening, phlebotomy, drug preparation and administration, progress notes, patient lab and imaging interpretation and analysis, patient safety, study regulatory reporting and online platform management

Durango, Méxic

• Taught basic science courses to Medical and Nursing School students, group sizes varied between 25 to 40 students

Ensenada, México

• Handled all the clinical aspects of the clinic including: patient histories, progress and discharge notes, diagnostic tests and prescription of treatments• Led patient and staff clinical education, prepared clinical reports, supervised nursing and administrative staff

San Francisco Bay Area

• Managed system integration projects and created, translated and implemented technical specification documentation for business requirements and product support• Responsible for identifying technical and operational problems in our disbursement networks and proposing appropriate resolutions, point of contact for all Latin America Partners

San Jose, Ca

• Managed relationships with third party local service centers for assigned region, contract and costs negotiation, parts and inventory control, certification of standard operating procedures and customer service technical training

Doctor Of Medicine - Md, Medicine

Master'S Degree, Hospital And Health Care Facilities Administration/Management