-Work with Sponsors, CROs, and vendors to resolve study, company, or personnel escalations that are beyond the scope of Project Managers-Assist in the management and oversight of project finances (e.g., invoices) and coordinate with accounting team to ensure financial accuracy and projections-Independently manage large organizational initiatives and change, from Job Aid and SOP development to new software implementation-Hold Regional Head responsibilities, including head of office role-OpenClinica (EDC/eSource platform) administrator co-leading the implementation of the platform, study specific source development, and ongoing system support for all study teams throughout the study lifecycle-All Associate Director tasks described below

-Manage clinical operations employee resources and projections to ensure that project teams meet client expectations, meet contractual obligations, and maintain appropriate accounting of activities and billable items-Provide guidance, mentorship, training, and supervision to departmental personnel-Ensure audit preparedness through review and enforcement of training, process, and SOP compliance-Participate in budget and new business activities by reviewing requests for proposals, assessing study strategies, and presenting in bid defense/capabilities meetings-Maintain and author SOPs and associated forms-Develop and track objectives and key performance indicators (KPIs) -Create reports, analyze results, and present findings-Develop and implement training programs for clinical operations personnel-Allocate departmental resources as appropriate to ensure employees are engaged in company initiatives and covering all assigned study obligations-Oversee and support clinical research study tasks for PMs whenever assistance or vacation coverage is needed-Strategize to identify, develop, and implement internal process improvement initiatives-Leader of technology related initiatives - i.e., vetting of vendors/systems, provide key points to Sr Leadership for decision making, develop training, implement use, maintain as administrator, etc.-QuickBase administrator and subject matter expert with MS Excel assisting all of Clinical Operations with formulas, validations, tables, and analyzing data

-Functional manager to a matrixed team of Clinical Project Managers and Clinical Project Coordinators-Provide training, support, oversight, guidance, and performance reviews to assigned team members-Monitor study projections and allocate resources as necessary -Strategic initiative developer offering suggestions for strategic improvements and act as a group leader for internal project teams-All Clinical Project Manager tasks from previous role

-Startup clinical studies, plan and monitor in-home clinical trial visits, and close out clinical studies-Primary liaison for internal and external cross-functional teams including nurses, study sites, CROs, sponsors, vendors, suppliers, pharmacies, and laboratories-Conduct study kickoff and other meetings; create original source material for study protocols; develop and deliver study protocol specific training; assign project level responsibilities to Clinical Project Coordinators and collaborate with them to accomplish critical tasks; deliver projects within time, scope, and budget-Proactively identify and mitigate risks while establishing and documenting corrective actions-Oversee nurse performance; review and approve nurse activities for payment and billing-Contribute to continuous improvement of all processes, protocols, and SOPs

-Presented compliance reports to clients and shared trend analysis insights -Created Adverse Event Compliance training and Personal Identifiable Information Privacy training -Program Manager for Centerfirst’s largest client and 6 of their patient support centers-Discovered process discrepancies between patient support centers that the client was unaware of and introduced the corrective measures to retrain and align the patient support centers-Handled operational tasks: Scheduling, budget and billing, escalated concerns, author and maintain standard operating procedures, and assist with service provider oversight plans-US Drug Safety Lead in charge of investigating and reporting all adverse events and quality complaints-Continued to assist with all Business Analyst tasks from previous role

-Provide updates to and create new working documents and standard operating procedures for multiple groups-Research new business opportunities, such as the practicality of speech analytics systems to expand reporting capabilities for call monitoring programs-Perform data analysis for multiple projects

-Monitored phone calls and documents in both English and Spanish to ensure compliance regulations are followed-Provided scripting ideas to improve client-patient relationships during phone calls

-Collaborate with nurses, doctors, and study coordinators to ensure that detailed data collection occurs through creating and implementing data collection worksheets, a quality assurance process, and standard working instructions-Revamped RECIST 1.1 tracking database to be more user friendly and simplify report printouts-Assist in the development of the data coordinator position through: Developing standard work instructions (SWI) regarding data entry; Developing SWI for regulating clinical research associate (CRA) data monitoring visits; Developing a dashboard layout and SWI for the use of a CRM program (Journey Book) built to track data requests, patient visits, and the metrics of completing each task-Trained as a Journey Book (CRM software) super-user for CTCA-Completed the first Leadership Development Program at Western Regional Medical Center (CTCA-Goodyear)-Serve as liaison between our research facility and other clinical research organizations/ pharmaceutical companies to create a strong working relationship with multiple organizations-Selected to be part of the stakeholder to stakeholder committee where we review and award stakeholder’s nominated for going above and beyond their standard duties-Use various electronic data capture/case report forms and consistently provide data entry and query resolution within the allotted time frame

-Manage new sales groups by coaching them up from training pod status to full representative status-Successfully developed over 25 new sales representatives by personalizing teaching tactics to match their learning styles-Consistently aid in the development of 42 sales representatives by providing one on one training, mentoring, and assisting in the closing of sales when they are having difficulty doing so themselves-Provide home security recommendations and services to protect the homes and families of customers-Expanded our national customer base by assisting the Spanish speaking population -Consistently exceeded the performance standards as a top performer which contributed towards my goal of becoming a Team Leader-Readily assisted other advisors through providing advice or taking over a phone call to help them close the sale

-Managed over 50, multi-million dollar pre-clinical studies using CRM software to ultimately exceed the clients’ expectations while satisfying GLP, FDA, AAALAC, and USDA regulations-Developed to be a Key Trainer-Mentored research associates in the U.S. and China and instilled scientific and operational practices to harmonize operations at every facility-Head of Employee Development group where we focused on assisting employees in meeting their educational goals-Active member of process improvement and process development projects-Exposure to Six Sigma through classroom lessons taught by the facility Black Belt-Contribute to revising standard operating procedures to improve efficacy

-Perform necropsy and histology tasks (trimming, embedding, microtomy)-Acquired specialties in animal perfusion, reviewing slides, and mentoring

*Position was temporary as I was attending school-Designed & implemented a training and evaluation exam for machine operators-Fabricated assembly templates to improve job precision & -synchronize results across multiple sites-Revised and maintained a preventative maintenance database to meet OSHA regulations

*Temporary position while attending school*-Managed schedules to increase the vehicle turnover rate and maintained sales/inventory records-Collaborated with clients to privide them with the products they need to meet their goals-Worked in teams to manufacture custom fabrications to meet customer specifications