• Pre-investigational site evaluation, initiation, monitoring and closeout visits, with on time data retrieval and trip reporting, per client requirements.• On-site review of regulatory files.• Assessment of trial site for compliance to protocol, GCP, ICH and SOPs, providing comprehensive findings report and corrective action plan.• On-site CRA assessment to ensure adherence to monitoring SOPs and study protocol, while maintaining data integrity and patient safety. Proved comprehensive findings report and corrective action plan.

• Pre-investigational site evaluation, initiation, monitoring and closeout visits, as well as on time data retrieval and trip reporting per project expectations and SOPs. • Ensured audit readiness of site regulatory files with no critical or major findings reported during internal site inspections.• Developed and implemented monitoring tools, increasing quality, productivity and efficiency while on-site.• Monitored multiple protocols and performed site management as required, while meeting or exceeding expectations for database lock timelines.• Provided audit preparation assistance to Field Trial Operation (FTO) CRAs prior to an internal audit. Reviewed regulatory documents and clinical data at investigational sites to identify non-compliance. Provided a comprehensive findings report and corrective action plan.• Partnered with FTO Managers and Site Management Leads by identifying and communicating critical issues impacting study outcome and timelines.• Conducted Field Quality Assessment (FQA) visits with FTO staff to ensure data integrity, patient safety and adherence to protocol, GCP, ICH and SOPs. Completed reports on time per SOPs.• Scheduled all bi-annual FQA visits and reviewed all reports for the Department to ensure consistency across the program for four Quality Associates.• Maintained FQA database used for scheduling, reporting, and trending. Reported monthly and quarterly metrics to senior management on time.• Facilitated discussions and resolution between CRA, Manager and Quality Associate during reporting disputes.• Developed training plans, facilitated orientation and training programs, provided coaching, and feedback to FTO staff through assessment opportunities and new hire training.• Reported to senior management and Training Department with recommendations for core curriculum improvements for staff development and training. • Maintained expertise through clinical literature review and yearly attendance at industry conference.

• Responsible for a multi-center, Phase III diabetes trial included protocol, informed consent and case report form design and development; selection of clinical investigators; site initiation; field monitoring; on site regulatory document review for FDA compliance. • Management duties included training and supervising six full-time regional CRAs and review of all monitoring and regulatory reports. • Additional responsibilities included study budgets, trial site quality assurance and acting as a mediator for sites that had not performed up to company standards. • Served as the liaison between company, investigators, and subcontractors in the resolution of day-to-day operation issues.

• Clients included pharmaceutical companies in the United States and Europe, as well as NIH funded research. • Responsibilities included design and management of Phase I through IV clinical trials to ensure the accumulation of valid scientific data for submission in support of an NDA. • Study monitoring for safety, efficacy, and regulatory/protocol compliance. • Developed Standard Operating Procedures for monitoring. • Design and implementation of database for clinical evaluation of data using Med Log.