Key Responsibilities:• Maintain a thorough understanding of assigned programs, protocols, and protocolrequirements• Study Design and Clinical Document Development• Give scientific input to program strategy and protocol design• Contribute to authorship of Study Protocols, ICF, Clinical Study Reports,Statistical Analysis Plans, Investigator Brochures, DSUR, Briefing Books, HealthAuthority Communications, Labels, etc.• Develop Clinical Narrative plan and reviews clinical narratives• Contribute to database build and authorship of clinical report form completionguidelines• Training• Educate study team members on protocol and protocol requirements• Provide training to sites and CRAs on protocol and protocol requirements andserves as primary contact for clinical questions• Study Conduct• Plan and lead implementation of study startup/conduct/close-out activities incollaboration with CTM as applicable• Provide input to vendor SOW, contract, charter development• Assist with vendor management to ensure scientific integrity of the services theyprovide• Organize Trial Committees (SC, DMC, BICR, etc)• Data Review• Review clinical data, including protocol deviations, to ensure accuracy of clinicaldatabase with an emphasis on scientific integrity• Identify trends in clinical data, provide trends and escalate medical questions tothe Medical Monitor• Review of MedDRA and WHODRUG coding• Evaluation of safety, pharmacology, and efficacy data at a program level• Represent Clinical Research at study team meetings or other meeting venues asneeded• Contribute to and review Clinical Research SOPs, Work Instructions, and Job Aids• Collaborate and serve as a primary liaison between external partners for scientific advice• Prepare manuscripts, abstracts, and presentations for scientific meetings• Train and mentor Junior Staff

Key Responsibilities:• Maintain a thorough understanding of assigned programs, protocols, and protocolrequirements• Study Design and Clinical Document Development• Give scientific input to program strategy and protocol design• Contribute to authorship of Study Protocols, ICF, Clinical Study Reports,Statistical Analysis Plans, Investigator Brochures, DSUR, Briefing Books, HealthAuthority Communications, Labels, etc.• Develop Clinical Narrative plan and reviews clinical narratives• Contribute to database build and authorship of clinical report form completionguidelines• Training• Educate study team members on protocol and protocol requirements• Provide training to sites and CRAs on protocol and protocol requirements andserves as primary contact for clinical questions• Study Conduct• Plan and lead implementation of study startup/conduct/close-out activities incollaboration with CTM as applicable• Provide input to vendor SOW, contract, charter development• Assist with vendor management to ensure scientific integrity of the services theyprovide• Organize Trial Committees (SC, DMC, BICR, etc)• Data Review• Review clinical data, including protocol deviations, to ensure accuracy of clinicaldatabase with an emphasis on scientific integrity• Identify trends in clinical data, provide trends and escalate medical questions tothe Medical Monitor• Review of MedDRA and WHODRUG coding• Evaluation of safety, pharmacology, and efficacy data at a program level• Represent Clinical Research at study team meetings or other meeting venues asneeded• Contribute to and review Clinical Research SOPs, Work Instructions, and Job Aids• Collaborate and serve as a primary liaison between external partners for scientific advice• Prepare manuscripts, abstracts, and presentations for scientific meetings• Train and mentor Junior Staff

• Clinical Operations Responsibilities included: o Drive all aspects of the project management process from initiation, planning, execution, control and closure. Manages all aspects proactively.o Assist in developing protocol concept sheet (study design, entry criteria and schedule of activities table).o Review protocol and CRFs and tracks development to completion. o Review study-related support materials created by the Monitoring and Data Management Groups (e.g. study manual, monitoring plan, edit check manual, Listing Review process). o Review actual trial conduct and quality at all levels (i.e. monitoring, data management).o Maintain detailed project timelines with updates to milestone reporting in MS Project, OnePager and Planisware.o Responsible for Vendor bid review and contract finalization as well as Vendor Management through the lifetime of the project.• Clinical Development Responsibilities included:o Assist the Medical Monitoring Team in development of trial design, leading the medical monitoring activities including the development of Medical Monitoring Plan and SAE reconciliation.o Review, update, and finalized ICFs. o Support Scientific Advisory Committee, Data Monitoring Committee, adjudication committees. o Assist with monitoring data issues requiring clinical input including central labs and imaging. o Participate in data lock activities.

• Act as the operational lead in the day-to-day management of full-service studies or act as the lead for local teams as part of broader, multi-regional programs.• Clinical Development Responsibilities included:o Serve as main point of contact for scientific issues. o Assist the Medical Monitoring Team in development of trial design, leading the medical monitoring activities including the development of Medical Monitoring Plan and SAE reconciliation.o Review, update, and finalized ICFs. o Support Scientific Advisory Committee, Data Monitoring Committee, adjudication committees. o Assist with monitoring data issues requiring clinical input including central labs and imaging. o Prepare scientific slides and presented during Investigators Meetings. o Participate in data lock activities. o Co-author newsletters and supported publications as needed. o Assess and review protocol deviation list for Clinical Study Reports.• Clinical Operations Responsibilities included: o Support design, oversee implementation, and delivery and reporting of projects. o Accountable for time, cost, and quality targets as well as resource and budgetary control throughout the life of the project.o Coordinate and direct cross-functional task leaders from all contracted services within ICON both locally and internationally and oversight of contracted third parties.o Serve as the primary contact for sponsors and internal ICON management during the project; Anticipate and manage risks and issues. • Ensure compliance with ICON SOPs, study contract and international regulatory requirements• Assist Program Manager on Partnership studies to ensure streamlined setup and operations of projects.• Line Management of a team of 10 CTMs to ensure timely and effective onboarding and training of new hires.

• Line Management of a team of 9 CTMs to ensure timely and effective onboarding and training of new hires.• Assist Program Manager on Partnership studies to ensure streamlined setup and operations of clinical studies.• Clinical Development Responsibilities included:o Serve as main point of contact for scientific issues. o Assist the Medical Monitoring Team in development of trial design, leading the medical monitoring activities including the development of Medical Monitoring Plan and SAE reconciliation.o Review, update, and finalized ICFs. o Support Scientific Advisory Committee, Data Monitoring Committee, adjudication committees. o Assist with monitoring data issues requiring clinical input including central labs and imaging. o Prepare scientific slides and presented during Investigators Meetings. o Participate in data lock activities. o Co-author newsletters and supported publications as needed. o Assess and review protocol deviation list for Clinical Study Reports.• Clinical Operations Responsibilities include: o Serve as primary point of contact for Clinical Operations aspects of designated projects. o Manage oversight of, and overall accountability for site selection; site start up (including submissions and Investigator contract negotiation); patient recruitment; site monitoring; data retrieval and study close-out. o Responsible for risk mitigation strategies, associated action plan and issue resolution, and contributions to the cross-functional project management plans. o Overall responsibility for managing the clinical operations project team and ensuring compliance with ICON SOPs, study contracts, budgets and quality standards.

• Clinical Development Responsibilities included:o Serve as main point of contact for scientific issues. o Assist the Medical Monitoring Team in development of trial design, leading the medical monitoring activities including the development of Medical Monitoring Plan and SAE reconciliation.o Review, update, and finalized ICFs. o Support Scientific Advisory Committee, Data Monitoring Committee, adjudication committees. o Assist with monitoring data issues requiring clinical input including central labs and imaging. o Prepare scientific slides and presented during Investigators Meetings. o Participate in data lock activities. o Co-author newsletters and supported publications as needed. o Assess and review protocol deviation list for Clinical Study Reports.• Clinical Operations Responsibilities included:o acting as the functional lead from clinical operations with oversight of, and overall accountability for site selectiono site start up (including submissions and Investigator contract negotiation); patient recruitment; site monitoring; data retrieval and study close-out. o Responsible for risk mitigation strategies, associated action plan and issue resolution, and contributions to the cross-functional project management plans. o Overall responsibility for managing the clinical operations project team and ensuring compliance with ICON SOPs, study contracts, budgets and quality standards.

Multiple clinical trials in a variety of therapeutic areas and indications, including, Allergic Rhinitis, Age-related macular degeneration, Chronic Migraine, Diabetic macular edema, Dry Eye. Responsibilities included:• Develop and maintain high quality, realistic, cross functional clinical trial plans from study concept through completed clinical study reports. • Develop the study timeline when the synopsis/draft protocol is available. • Partner with Project Management and Regulatory Affairs to implement project strategies and improve efficiency by identifying and implementing new business processes.• Develop and maintain NA/ROW clinical study timelines to meet all deliverables.• Partner with the Clinical Development lead, Global Operations department and the study team to ensure timely delivery of all clinical milestones. • Identify gaps and risks in the study plans and work with the team and Management to proactively develop solutions to increase efficiency and minimize timelines.• Partner with Pharmaceutical Sciences Strategy to ensure timely delivery of milestones.• Define baselines and provide metrics to identify areas and trends that can be used by the teams for future enhancements.• Present clear clinical study plan reports to stakeholders within company.• Partner with study team leaders to tactically drive critical path elements within the study.• Work collaboratively with Global Recruitment Operations, Global Site Start Up Operations and CRO Oversight to advantageously reduce timelines for study start up activities.• Operate within the Actavis Governance Board model for communication and accountability.• Provide continuous improvement on individual clinical study plans and standard MS Project and Planisware templates.• Assist in developing the department portfolio based schedules and resource planning methodologies.• Identify state of the art planning tools to minimize deviations from established timelines.

• Schedule and conduct monitoring activities at participating centers assessing site compliance with the Clinical Investigational Plan (CIP), Regulations (FDA, State, etc.), Good Clinical Practices (GCP) and evaluate reported data for accuracy. • Review monitoring findings, review monitoring reports and address site specific challenges. • Responsible for data review and approval of DCFs; Have understanding of the interactions between forms and can propose solutions to most questions of data completion • Assist in the development of Protocol and Case Report Forms. • Medical writing of all safety narratives for Clinical Events Committee, Data Safety & Monitoring Board and bi-annual report to FDA; final CSR submission review & editing • Work effectively with cross functional teams to achieve divisional goals.• Work within clinical database systems.• Respond site questions related to the clinical study execution.• Ensure collection of all relevant data and source documentation. • Ensures the clinical study site adheres to the assigned protocol and all applicable regulatory standards.• Assist with developing training materials.• Conduct training visits• Assist in the development and review of informed consent to ensure all required elements are included. • Assist in development of study related materials such as: subject brochures, subject recruitment materials, physician referral presentations. • Able to explain the device procedure, features and required accessories associated with device.• Builds and maintains productive working relationships with internal and external customers.• Apply general clinical research process and regulatory knowledge to process improvement activities

Coordinate device and drug treatment research trials, as well as observational & retrospective studies conducted at Texas Center for Joint Replacement, including but not limited to study set-up, implementation, fiscal monitoring, and data collection/entry. Manage the coordination of all aspects of the assigned research project(s) at TCJR in support of the Principal Investigator and ensuring compliance with all THR's policies, state and federal regulations that govern clinical research.• Evaluate patients for inclusion and exclusion criteria on multiple protocols. Consent and enroll subjects on trials as appropriate. Be familiar with treatment and visit schedules for assigned studies. Coordinate/perform scheduling of procedures and treatments and serve as an educational resource for participants regarding study requirements.• Be proficient at reviewing medical records to assess patient’s disease status, treatment course, and adverse events. Complete case report forms and submit to sponsor according to deadlines. • Participate in long-term follow-up efforts on research participants and submit on-going data. Communicate with pharmacy to ensure investigational drug is ordered per protocol when needed. • Open and maintain institutional approval for research studies including but not limited to initial THR Institutional Review Board submissions (creating consent forms, HIPAA forms, project summaries), new research questionnaires for IRB and THR’s Medical Center Research Department, amendments, annual reviews and adverse event reporting.• Consult with THR’s Research & Education Department to establish study budgets and ongoing oversight of research billing to ensure compliance with laws regarding research billing. • Communicate with sponsor to keep all documents updated. Communicate with physicians and clinical staff regarding patient research participation.

Responsible for audit and monitoring of current research admissions procedures to identify problem areas and implement solutions for smoother process flow. This was done using the following Lean Six Sigma tools:• Comprehending and creating the SIPOC Diagram• Overview of Process Mapping (the 6 foot view)• C&E Matrix• Effects Analysis along with Failure Modes• Fundamental Statistics• Developing Graphs (fundamental quality tools)

Voluteer

Volunteer

Developed in-vitro hypoxia model and an in-vivo ischemic stroke model for study titled “Identifying novel therapeutic targets in eicosanoid and heme metabolic pathways in a rat stroke model”. Real-time PCR was used to analyze intermediates in the eicosanoid and heme metabolic pathways.As an Investigator Initiated Research Associate provided primary support to Principal Investigator with necessary communication and coordination to ensure efficient processing of Investigator Initiated Research (IIR) requests.• Responsible for writing study protocol as per State and Federal regulations. • Responsible for ensuring study progress including document management and distribution, ensuring entry of IIR IACUC proposals into the system, monitoring proposal status for Principal Investigator, and securing and entering study closure documentation.• Reviews incoming requests and documents for accuracy and completeness and/or enters requests into systems, including uploading and scanning.• Entry of information into the IIR system, acknowledgment communications, and requests for additional information or documentation through the entire lifecycle of assigned study.
• Completing the IACUC submissions to address missing information and ensure compliance of State and Federal policies on Safety Reporting, and Privacy.• Manage distribution of documentation, preparation of agendas, and assists with scheduling coordination necessary for Review Committee meetings.• Manages the transactional details of drug supply requests (i.e. generating drug supply forms) and works with Program Managers and Pharmaceutical Sciences Supply Chain Coordinators to ensure clinical supply forecasts are up-to-date and supplies are available as required for the study. • Input study milestones into the system and assisted Principal Investigator with status report queries, as required.• Contributed to process and technology improvement projects within areas of responsibility, as requested.

Managed and coordinated “Stroke Program Neurovascular/Neurogenetics Database” by recruiting patients, obtaining informed consent, and collecting tissue samples that were processed and stored.Coordinate and conduct research protocol to ensure quality, consistency, timeliness, accuracy and patient safety.• Participate in the design, administration and monitoring of clinical trial.• Identify, evaluate, and recruit qualified potential subjects for study.• Analyze and evaluate clinical data gathered during research.• Manage data collection, ensuring adverse events (AE) are identified and reported per protocol compliance.• Assist in the planning and design of source documents for study protocols as required.• Update and review regulatory documents to include annual IRB approvals, protocol amendments, and safety reports, process data queries and ensure resolution• Timely completion of identified study documents including case report forms.• Responsible for assuring compliance with FDA and GCP guidelines.

Clinical Research Assistant II in the Cardiac Surgery Department on a retrospective chart review titled “Laser Lead Extraction for removal of Pacemaker and Defibrillator leads using the Excimer Sheath Laser system: A retrospective look at results and complications.”Site initiated quality control study to assess the risks and benefits associated with using the CVX-300 Excimer Laser system for the extraction of defibrillator and pacemaker leads. • Monitored performance/progress of clinical site relative to regulatory approvals, study enrollment, protocol compliance, and adherence to safety reporting requirements.• Review patient files to prepare requests for source document collecting for the clinical endpoints committee adjudication.• Generated comprehensive reports related to performance of various job functions.• Develop narratives from multiple sources of adverse event reporting and/or complaint review forms in order to facilitate Safety Officer’s and CEC’s (Clinical Events Committee) reviews, in accordance with regulatory requirements.• Support for Safety Officers in daily safety review, reports, data reconciliation, and identifying necessary source documents.• Provide additional information and updates to the complaint handling group regarding patients’ outcomes and associated/related complaints• Advise research coordinators and CRAs to properly report adverse events and provide the proper supporting documentation for SAEs (serious adverse events).• Supporting CRAs and sites on AE reporting training and cross-function training and expertise regarding complaints handling• Proactively supported company goals and objectives, policies and procedures, and Good Clinical Practices. Ensure compliance with applicable FDA requirements.• Participated in company Staff meetings and planning sessions. • Maintained a professional and credible image with key physicians, consultants, vendors, and co-workers.

Research Assistant for Osteoporosis Study: Recruited patients from Osteoporosis clinic for a large bone imaging study. Follow regulatory guidelines to gather and store data on secure database. Own master study binders and work with Clinical Research Coordinator to analyze data collected. • Followed Good Clinical Practice requirements with all clinical trials to provide assurance that data and reporting results were credible and accurate, and that the rights, integrity, and confidentiality of trial subjects protected.• Communicated with patients, medical staff, sponsor research associate, and research program manager.• Assured patient understanding and compliance with study protocol and compliance with study visit windows and study procedures• Accurately completed the study case report forms and patient status documents ina timely manner.• Worked with the principal investigator to insure that study subjects meet the protocol inclusion/exclusion criteria. • Obtained informed consent, as requested. Worked together with the PI to provide optimal patient care and safeguard patient confidentiality.• Screened patients utilizing methods developed for patients who responded to advertising, press releases, newsletters, posters, etc.• Scheduled patients in accordance with protocol requirements and insure patients received required tests and exams at each visit. • Maintained accurate, original source documents in medical records in a manner acceptable to the sponsor• Maintained the Regulatory Binder provided to retain correspondence, Institutional• Review Board correspondence, laboratory certification and normal ranges, regulatory documents required by the FDA

Clinical Research Assistant I in the Cardiac Surgery Department on a retrospective chart review research project titled “Hypertrophic Obstructive Cardiomyopahy (HOCM): Surgical myectomy versus medical ablation treatment outcomes.” Site initiated study to compare surgical versus medical treatment for Hypertrophic Obstructive Cardiomyopathy.Clinical duties: • Served as principle clinical research associate of the Cardiothoracic Surgery Service.• Explained the purpose of the project in a clear and concise manner to assist with obtaining informed consent from patients interested in participating in the study.Research duties:• Responsible for study design and IRB proposal. 
• Coordinated all aspects of data collection, including enrolling patients and abstracting data from medical records. 
• Assisted with analysis of data. 
• Assisted with research activities including grant writing and conduction of research protocols.• Assisted with writing research articles and other publications. 
• Worked with the research team to review data and make recommendations in regards to data collection and analysis.• Present study findings and updates at weekly Cardiothoracic Grand Rounds.

Clinical Research Assistant I in the Cardiac Surgery Department on a retrospective chart review research project titled “The NEECHAM Confusion Scale: Detecting Delirium in hospitalized patients.”Site and principal investigator initiated study to review NEECHAM confusion scale on post operative patients.• Responsible for write up of study protocol and submission of IRB proposal for approval of study• Carried out extensive chart review to collect pre and post clinical data • Designed a secure database in ACCESS and EXCEL for all patient data• Obtained informed consent and recruited patients that were undergoing Cardiothoracic surgical procedures• Assessed confusion scores for patients by using the NEECHAM confusion and the Mini Mental Status Exam pre and post surgery for comparative score records• Attended weekly rounds with Cardio-thoracic team to discuss findings and suggest additional data points or improvements for the studyAs second author of this unpublished study we compared the NEECHAM scale to other bedside mental status tools to detect confusion/delirium. The study also assessed using the NEECHAM Confusion Scale to detect delirium in post-op cardiac surgery patients.