Omar Gonzalez Email & Phone Number

Cambridge, Cambridgeshire, Gb

• Contributes to the selection of potential investigators. • When delegated, accountable for study start-up and regulatory maintenance.• Trains, supports, and advises investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles • Ensures sites are inspection ready at all times.• Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.• Performs monitoring visits (on-site and remote) and remote data checks in accordance with specified timelines.• Ensures compliance with local, national and regional legislation, as applicable.

Cincinnati, Oh, Us

• Responsible for on-site and remote clinical trial monitoring per Medpace/Sponsor SOPs, ICH-GCP guidelines, and local regulations.• Completion of the PACE training program• Certified training in Infectious Disease and Cell & Gene Therapeutics• Phase II and III clinical trial monitoring experience.• Indications/Areas of Experience: Hematology, Infectious Disease, Rare Disease, Ophthalmology, and Immunology.• Blinded and Unblinded monitoring experience • Primary and Co-monitoring experience • Has independently conducted pre-feasibility, site initiation, routine monitoring, and site close-out visits.• Assigned to multiple protocols across various therapeutic areas at a given time.• Responsible for trial site communications, site study training, travel, regulatory submissions, issue resolution, investigational drug monitoring and reconciliation, monitoring of subjects safety, CTM and Lead CRA support, serious adverse event reconciliation, and other standard trial monitoring duties.• Mentored CRAs in training.

New Haven, Ct, Us

Department: ImmunobiologyAdvisor: Jeffrey Bender, MDField of Study: Immune cell post-transcriptional regulation by an RNA-binding protein, HUR; Cardiomyocyte-Macrophage interactions.

Beaumont, Tx, Us

Topic: Site Directed Mutagenesis of Bacterial Hfq ProteinAdvisor: Dr. Maxim Soukhodolets

Beaumont, Tx, Us

Thesis: Hazards of Home-grown Mung Bean Sprouts and Efficacy of Disinfection Treatments.Advisor: Dr. Ashwini KucknoorPresented at: SACNAS 2017; 18th Annual McNair Scholars Research Symposium at Lamar University

Beaumont, Tx, Us

Working on a team to analyze levels of fecal coliforms in Southeast Texas beach water for the Texas General Land Office (GLO).

Beaumont, Tx, Us

Topics: Characterization of Tritrichomonas foetus rhomboid proteases; The role and significance of filamentous proteophosphoglycans in Leishmania amazonensis.Advisor: Dr. Ashwini KucknoorPresented at the Lamar Undergraduate Research Exposition 2016

Master'S Degree, Immunology

Bachelor'S Degree, Biology, General