Provide Project Management services to Sponsors and CROsProvides CTM/CTL services to Sponsors and CROsExecution of trials from study startup to closeoutResponsible for project deliverables within timelinesManagement of KPI, quality, and clinical operations delivery

Manage and lead a team of CRAs to ensure that study visits are conducted per CMP and SOPsEnsure site visits are conducted per the CMP and that SDV is being performed Facilitate communications between the CRAs and the SponsorCollaboration with Vendors to ensure the efficiency of study progressLiaised with Clinical Operations Managers to resolve clinical resource and performance issues Review of project-specific plans, documents, and tools for the clinical teamPlanned, oversee and conducts initial and ongoing training for the study team on clinical project specificsSupport the interviewing and hiring of study team membersFacilitate study team meetingsConduct site visits per Ardelyx CMP and SOPs

Oversee the overall clinical operations of a Phase 1 TrialPrimary contact for the project team, clients and vendorsClient interfacing and ensuring deliverables are met in a timely and efficient mannerLead and manages the start-up and clinical teams Managing on-time execution and conduct of clinical trialsPlan and lead execution of the day-to-day activities for the monitoring of a clinical study and communicates consistently with the clinical team providing project objectives, expectations and status updatesWorked with the team to set priorities Create study plans such as Project Management Plans, Clinical Management Plans and Trial Master File Plans.Collaborate with project team members to author project team meeting agendas and capture meeting minutesReview study budget to ensure tasks are performed per the study budget and within timelinesManage vendors across assigned projectAssess and appropriately delegate tasks within the assigned program to team members; ensure assigned tasks are progressing according to timelineTrip report review and approval

Leads and manages the start-up and clinical teamsPlans and leads execution of the day to day activities for the monitoring of a clinical study and communicates consistently with the clinical team providing project objectives, expectations and status updates.Works with the team to set prioritiesTakes the initiative to make things happen and leads and supports the Country Start Up Specialist (CSS), Global Regulatory Affairs Lead (GRAL), Local Regulatory Affairs Lead (LRAL) and In-House Clinical Research Associate (IHCRA) to ensure the successful activation of trial sites according to time, quality/scope and budget parametersWorks with the Director of Project Delivery (DPD) to ensure all Clinical team members are adequately assigned to the projectForecasts as per the contractually agreed FTE, tailoring forecasts to peaks and flows of activities throughout the project durationActively monitors initial and ongoing clinical resource and identifies/escalates issues to the Project Manager (PM)Liaises with Clinical Operations Managers to resolve clinical resource and performance issuesDisseminates and agrees forecasted activities/FTE to all key team members Quality – Training & DevelopmentCreates and maintains project specific plans, documents and tools for the clinical team.Plans, oversees and conducts initial and ongoing training for the study team on clinical project specificsOversees the GRAL, LRAL and IHCRA to ensure that all non-safety periodic updates, progress reports and renewals and/or end of study notifications are performed in accordance with the trial protocol, local regulations, ICH-GCP and any other processes or procedures governing the clinical trial.Forecasts units and hours and generic resources for the start-up and monitoring activities, determines worked units and hours, analyzing forecasted and worked activities to ensure adherence to contract and budget

Responsible for the management and monitoring of Multiple Protocols Responsible for performing study site management activities regarding the implementation, monitoring, and summarization of clinical trials to ensure adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations and SOPs. Develop and maintain collaborative working relationships with clinical investigative sites. Serves as the primary contact for clinical investigative sites on multi-therapeutic trials. Performs and facilitates study start-up activities including site initiation and training, providing site level information for country recruitment plan, etc. and evaluate site recruitment activities. Ensure site understands protocol requirements, study conduct, and adherence to ICH-GCP guidelines, local regulatory requirements and SOPs. Ensure regulatory files at the sites and in archives are current and in compliance with GCPs and SOPs. Verify timely submission of study documentation (including AEs/SAEs safety reporting) according to internal SOPs.Conduct study close-out activities and ensure investigator understands requirements for archiving clinical investigative files.

Dec 2009 * Nov 2010)Collaborate with PIs and Coordinators to conduct clinical trials according to ICH/GCP standardsInvolve in the delivery of patient care as it relates to the protocolPre and post assessments of patients during clinical trialsReview of protocols to ensure accuracy of information prior to initiation of clinical trialsAssess patients during initiation, follow-up and close-out visitsComplete all necessary specimen collection, medication administration, assists with study specific procedures and review of history during all visits

Site Management Organization committed to making a smooth process of clinical research. We ensure that Investigators and Subjects are equipped with all tools necessary to conduct an effective clinical trials.

Managed complex trauma patients on ventilators, balloon pumps, Continuous Renal Replacement Therapy, various sedatives and cardiovascular IV medicationsFunctioned as preceptor to new staff as well as nursing students

Managed complex patients on chemotherapy, Continuous Renal Replacement Therapy, vaso-active drips, sedatives and paralytics as well as mechanical ventilationChairperson of Wound Care Team with aggressive prevention and management of various wounds keeping incidence at less than 5%Chairperson of Patient and Family EducationTaught critical care courses with a focus on neurology and endocrine systemsAttended TRENDS * a yearly seminar to increase department*s knowledge of new products as well as treatment plan as approved by the FDAPerformed as Charge Nurse in collaborating with physicians and admissions to ensure appropriate admissions and discharges Mentored and trained new staff including physicians, nurses and ancillary staff

Traveled to many states as a nurse in various specialtiesProvided care in rehabilitation as well as Long Term CareWorked with a wound care specialty team in the treatment of wounds utilizing various products such as Procurin and Xenaderm