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.

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.

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.

Doctor Of Medicine - Md, Medicine

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