Project Management - Recommends and/or develops guidelines and refinement of guidelines in the collection of clinical data and administration of clinical trials; assists in the determination of guidelines for new protocols. Develops improvement in processes to increase efficiencies. innovates and adapts research processes and guidelines including designs, methods, and data. Consistently provides new perspectives to issues.Problem Resolution- Anticipates and addresses simple or complex operational problems at any study phase. Recognizes when issues need to be escalated to senior management in a timely manner. Proposes resolutions and leads these initiatives with assistance as needed.Team Management- Consistently recognizes the contributions of other team members. Exhibits inclusive approach to decision making and goal setting processes. Fosters group ownership of and enthusiasm for project. Assigns specifics tasks in order to challenge team members while encouraging professional growth. Follows-up routinely with feedback and encouragement. Coordinates, leads, and manages, as required, the work of the project staff and research team, and provides feedback to staffs supervisor on a routine basis; conducts cross functional research team meetings as needed.Financial Management- Proactively finds operational efficiencies in order to increase return on sales. Proactively changes resource utilization accordingly to the demands of the project to ensure efficient personnel utilization.Independently interprets and acts upon project-specific financial reports. Communication Skills- Appropriately exhibits persuasive communication skills to enhance the likelihood of building commitment and buy-in. Establishes, builds, and fosters relations with influential decision makers both internal and external. Actively participates on non-research project initiatives. Accountability Identifies and follows through on opportunities for self-improvement.

Critical leadership of team monitoring viral activity for ongoing infectious disease.Direct, hands-on guidance concerning improved processes for clinical trials, including biomarker and genomic components, resource management, quality assurance and site-compliance issues.Conduct meticulous site audits, provide preventive action plans to ensure site compliance with Federal and state regulations, and prepare detailed report of findings and sponsor responses.

Develop, coordinate, and implement monitoring administrative strategies essential to the successful management of clinical trials research conducted by the principal investigators at the Duke University School of Medicine. Participate in site selection and training site personnel regarding the trial. Perform site routine monitoring of the trial and follow-up to ensure identified deficiencies are corrected. Travel as required inside and outside of the USA to accomplish responsibilities. Educated medical and research professionals on requirements of ICH, cGCP, CFR, FDA, and other regulatory mandates.Coordinate the development of protocols, documentation, and standard operating procedures for the administration and monitoring the clinical trials. Follow established guidelines in the collection of clinical data and/or administration of clinical trials; assist in the determination guidelines for new protocols.Coordinate the assessment of the suitability of potential investigative sites through telephone screening interviews, regulatory document review and disseminating clinical trial information. Conduct site qualification visits to determine adequacy of facilities and staff, patient recruitment and retention potential, ability to comply with regulatory requirements, and overall interest and commitment of principal investigator to conduct and complete the planned clinical study.Provide feedback to assist sites which includes summary of overall site functioning and detected deficiencies and corrective action needed, follow-up with sites until deficiencies are resolved.

Coordinated and assessed the viability of potential investigative sites through telephone screening interviews, regulatory document review and discussions with site staff concerning clinical trial information. Drafted site questionnaires to assess the suitability and qualification of an investigative site to conduct a clinical trial.Designed and coordinated the use of site tracking tools to gauge interest and site contact information. Designed reconciliation tool and template used to correct/monitor critical data used for interim analysis. Provided resources and guidance on process improvement. Draft and reviewed SOPs to meet regulatory, business, and functional requirements. Arranged work schedule to meet timelines and project mandated objectives.

Performs auditing of all clinical trials for compliance and eligibility. Provides resources and guidance on process improvement. Prepares reports and presentations of audit findings. Located regionally to provide optimum client coverage. Arranged work schedule to meet timelines and project mandated objectives.

Performs and coordinates all aspects of the clinical monitoring process in accordance with CGPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. Conducts site visits to determine protocol and regulatory compliance, and prepares required documentation. Represents PPD in the global medical research community and develops collaborative relationships with investigative sites and client company personnel. Types of Visits Trained and Certified to Conduct:Pre-Study Evaluation Visit, Site Initiation Visit, Interim Monitoring Visit, Site Close-Out Visit

Recruit clinical trial sites, determine feasibility and site requirements, review regulatory documents, provide protocol training, and maintain a proactive approach to compliance per CFR and cGCP.

High throughput chemical analysis of inhalation and solid dosage forms under cGMP, ICH, and USP guidelines. Products tested include Ventolin HFA, Flovent, and Advair/Seretide MDI; 5FU, Abacavir, Retrovir, TrizavirTesting included Karl Fisher coulometric titration, FT-IR identification, HPLC for total dose content, cascade impaction of aerosols for fine particle mass, Leak rate determination, Dosing Through Use (DTU) for content uniformity of multidose inhalers. Participated in Design of Experiment Root Cause projects for Advair MDI. Validation testing of electronic data capturing tools and templates for ENB. Decommissioning/qualification of cGMP regulated lab equipment, including Anderson Cascade Impactors, Cox Tracers, LabCal Flowmeters. Assisted project planning and resourcing by active sample monitoring. Prioritized own work and manage own time to effectively meet timelines. Identifies, implements and continuously improves work processes. Anticipates customer needs and continually searches for ways to increase customer satisfaction. Maintains procurement and deliverables for laboratory supplies to support global harmonization.Acted as liaison between import/export shipping, vendors, and Customs to track and guarantee delivery of pharmaceutical products and both capital and non-capital lab equipment involved in global testing.

Receive, process, and inventory pharmaceutical samples for controlled testing environment. Assist in project scheduling, laboratory support services, report generation, and analytical testing. Prepare and review experiments for cGMP compliance. Evaluated and help implement new inventory tracking system using barcode technology and current Information Systems integration. Perform physical testing, of inhalation products and standards including: moisture analysis by Karl Fisher titration, FTIR identification, and HPLC analysis. Familiar with OOS and Atypical result testing. Conducted contamination investigations for root cause analysis. Created logbooks for various instrument and procedural QA/QC according to cGMP, SOPs, and other commonly accepted best practices. Active in stability protocol review for FDA NDA /PAI studies. Participated in bi-annual process review of testing methodologies and documentation in accordance to cGMP regulations. Trained new staff in proper experiment design, preparation, and documentation. Acted as lab supply manager responsible for all non-capital purchases.

Receive, process, analyze medical and biological samples using automated and manual process systems. Review and release results of medical tests for diagnosis.Perform and document daily QA/QC procedures to ensure test reliability. Conducted root cause analysis involving critical, OOS, or atypical results.

Screening of patients for clinical trials studies Participated in three JCAHO inspections.Fill medication orders.Review of dosing regimentIV admixture.Provide information to healthcare professionals concerning medications and dosing. Compounding.InventoryNarcotic SecurityOrder EntryQA/QC inspections Aseptic TechniqueAdminister Automated Dispensing AccessTrouble Shooting Dispense Systems.Evaluated and recommended various technologies to insure more control over prescription and dispensing of pharmaceuticals. Trained new employees in proper job function and documentation in accordance to JCAHO best practices.Identify medications using computerized databases. Prepared patient information packets n various medications.