Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance•evaluate overall performance of site and site staffAssesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues•Verifies required clinical data entered in the case report form (CRF) is accurate and completeVerifies site compliance with electronic data capture requirements•May perform investigational product (IP) inventory, reconciliation and reviews storage and security•Verifies the IP has been dispensed and administered to subjects/patients according to the protocolMay act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA)•Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements•Prepares for and attends Investigator Meetings and/or sponsor face to face meetings•Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements•Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow- up

Conduct clinical research with Pediatrix Medical Group in maternal-fetal, newborn and pediatric medicine within 33 states and Puerto Rico.Manage all aspects of a sponsor study to include regulatory, source verification, data entry, case report form completion, and weekly reports.

Promoted Access to Patients (ATP) program in the Tucson area to expand physician participation in clinical research trials. 
Recruited 2 sites and brought 2 partner sites on board Quintiles ATP program. Directed two influenza vaccine trials of 340+ subjects in the Tucson, Arizona clinic. Ensured quality in a successful sponsor audit. Directed a team of 4-8 coordinators through the consent process, subject visits, electronic data entry and query resolution. Oversaw and monitored the quality of an erectile dysfunction study at a partner site. Available for Phoenix area partner site as backup. All project deadlines were met for all projects. Liaison to the investigator, the subject, the institutional review board, and sponsor. Completed all regulatory documents and ensure compliance with FDA regulations for conducting clinical trials.

Rheumatology•Senior Site Clinical Research Coordinator - Responsible for all aspects of conducting pharmaceutical trials. Including investigational study selection, budget preparation, regulatory document preparation and project negotiation. Ordering supplies, training and record retention of clinical research staff training. Create SOP and review current SOP. Liaison between physicians, sponsors, contract facilities and CRO’s.

Retina *Clinical Research Coordinator - Responsible for recruiting and pre-screening patients for current and upcoming studies. Prepare and submit all regulatory documents. Negotiate budgets and contracts as well as bill procedures. Coordinate all study visits to occur according to protocol.

Asthma/Allergy*Clinical Research Coordinator - Responsible for coordinating clinical trials in compliance with FDA regulations as well as adhering to Good Clinical Practice guidelines. Attend investigator meetings; prepare telephone interview forms, source documents, patient instruction sheets, and any other special papers needed to begin a study. Conduct telephone interviews with subjects to ensure such subjects are qualified for the specific study. Consent subjects and answer any questions regarding the study.