Sandra Morones, Rn, Bsn, Msph Email and Phone Number

• Collaborate with the Assistant Vice President and Project Manager for Research Education and Development to develop a comprehensive educational program for the human subject research enterprise. Use principles of adult learning to plan and develop materials for use in educational programs geared to the target audiences and experience levels. Plan, develop, and coordinate the new employee orientation for research personnel in collaboration with the Clinical Research Offices (CRO) and the Center for Translational Science Award Program (CTSA).• Created original content for 150+ pages of a 270+ page online Clinical Research Handbook for UTSW faculty and staff to utilize that includes information regarding departmental, committee, and affiliated hospital information. Continue to update annually and publish• Worked with leadership to launch a new coordinator-focused CITI course that includes novel video content and recorded content to introduce the UTSW and affiliated site clinical research structure. This also included designing a multi-level clinical research training website and FAQ as well as escalation process to track all new hire completion. Since execution the course has met 100% compliance for all employees assigned to the course • Created a novel Clinical Research Foundations Level Mentoring Program from the ground up to plan and develop materials for use in educational programs geared to the target audiences and experience levels. This included designing training resources and activity modules, a REDCap database system to track Mentor and Mentee dyad pairs utilizing surveys, and gathering significant reportable data to the NIH for continued CTSA grant funding• Project Manager for the first annual Clinical Research Professionals Day campus event with over 300+ attendees from UTSW and Parkland Hospitals

• For campus-wide research, performed thorough protocol pre-review in advance of submission to the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) and provide technical consultation to Principal Investigators on any regulatory, scientific, or policy issues that will affect the likelihood of IRB/IACUC approvals• Developed, cultivated, and maintained working relationships with internal/external departments/agencies and other organizations associated with and/or receiving benefit from the research program• Established research program goals and objectives, directed clinical trials program evaluation and quality control activities, and responsible for designing, executing, and overseeing all of systems, providing reasonable assurance that operations were effective and efficient

• Responsible for the oversight of the Radiation Oncology Center’s clinical trial portfolio and all related regulatory, compliance, and performance metrics development, developing criteria where necessary, and determines which projects to prioritize• Supported and actively contributed toward the Finance team’s oversight and management of the department’s portfolio for new and ongoing trials, assists with negotiating favorable contracts with multi-disciplinary teams as well as external vendors, and ensures appropriateness of expenditures from various funding sources• Actively participated in screening and hiring new staff, including training/onboarding, evaluating performance biannually and annually per institutional guidelines, implementing metrics to measure stretch goals to support personal growth and development that aligned with UTSW’s mission, and followed disciplinary action as needed per UTSW’s policies• Initiated and maintained collaborative relationships between the clinical research unit and various facilities, both within UTSW as well as partner organizations such as Parkland Healthcare System, to facilitate ongoing projects

• Responsible for the oversight of the Neuro-Oncology's clinical trial portfolio and all related regulatory, compliance, and performance metrics requirements. Assumed responsibilities related to research operations, data management and clinical trial monitoring, staff hiring, supervision, training and development, and the department's financial goals as defined by Senior Research Leadership and the DFCI Clinical Trials Office (CTO)• Managed the clinical trial activities for up to 19 research staff consisting of clinical research coordinators, research project managers, regulatory coordinators, and research monitors in Neuro-Oncology on behalf of DFCI located in Boston and Brookline, MA• Supported the ongoing creation, expansion, and successful execution of PI-Initiated trial development, including multi-center site oversight, with DFCI acting as the sponsor-investigator• Oversaw the processing of both sponsored and PI-IT protocols through DFCI Institutional Review Board (and central IRB) when appropriate, collaborate with the DFCI CTO, the Office for Human Research Studies (OHRS), and the Office of Data Quality (ODQ) to fulfill local and federal requirements governing human clinical trials

• Built, reviewed, and approved accurate and complete Gastrointestinal and Pediatric oncology order sets in the hospital’s EMR system for execution by hospital personnel to ensure compliance with pharma/biotech and government-sponsored research protocols• Developed and oversaw the delivery of training program for new protocols, including the creation of training materials, nursing in-service presentations, and other materials as specifically required per protocol for audiences that included both clinical and non-clinical staff at Smilow Cancer Hospital as well as all Yale Cancer Center satellite locations throughout Connecticut• Directed the prioritization and served as liaison to the EMR administrator, Clinical Research Support Lab personnel, research pharmacists, Principle Investigators, research support staff (e.g. Finance and Regulatory), and CROs/sponsors as it related to the building and approval of research treatment plans in the hospital system

• Provide day-to-day supervision and promote Good Clinical Practice by department clinical research staff (ranging from 6-10 employees) consisting of nurses, interns, and contractors, in Abdominal Transplant, Nephrology, and Hepatology clinical research studies• Actively recruit new studies to our site while managing the successful execution of approximately 45 studies (Phases I-III) in various stages of enrollment and long term follow up (1 to 5 years)• Train nursing and non-clinical staff new to the research field in concepts and applied skills• Develop, negotiate and monitor budgets ranging from $320 to $68,000 per patient while working closely with BSWRI, Finance, Contracts, Clinical Research Organizations, and study sponsors• Develop or assist in the development of protocols and grant proposals for PI-initiated studies• Oversees regulatory document collection and submission application process (both local and central), and ensures that project documentation, including Trial Master Files (TMFs), are complete, audit ready, and adhere to federal, state, and local IRB guidelines• Assist site in meeting enrollment goals by obtaining informed consent, randomizing subjects, administering investigational product via IV, pills, or medical device, completing all electronic or hard copy case report forms, and overseeing regulatory compliance

• Coordinated with the PI, Pharmacy, and staff at the Sammons Cancer Center Transplant Institute on various studies, administer study medications via IV or dispense pills per protocol, and updated staff members on site and via teleconference regarding ongoing study developments• Enrolled potential subjects for clinical studies by monitoring daily operating room reports and/or reviewing referral lists from the PI’s and their staff, meeting subjects in the clinic or pre-op to obtain informed consent, randomizing subjects and ensuring that all study procedures are done per protocol, and completing all applicable electronic and hard copy case report forms and data entry into the hospital central management system, overseeing regulatory compliance, and creating and managing budgets• Precepted 1-2 senior nursing students from the Baylor School of Nursing each semester

• Collaborate with the Center’s field and Baltimore-based research teams to assist in the development, coordination and delivery of clinic and field-based public health services through the immunization of Native American children at the Northern Navajo Medical Center in the Department of Pediatrics• Responsibilities include enrollment of study participants, computer data entry, compilation and timely submission of summary reports, accurate record-keeping of all study participant data, monitoring of clinic visits and hospitalizations of study participants, chart reviews, home visits, specimen collection and processing, and study subject follow-up• Occasional field-based surveillance at various hospitals on and surrounding the Navajo reservation to investigate and document outbreaks of streptococcus pneumoniae

Collaborate with the Director, Policy and Planning Director, and staff to develop, update, and administer multi-agency homeland security initiatives and other emergency support functions by researching best practices and trends in government management for citywide, interagency preparedness. Independently prepared several deliverables including an executive proposal to the city leadership to maintain a fully integrated emergency medical delivery system for Baltimore City. Prepared a city-funded, mass casualty, full-scale exercise plan.

• Conducted literature review searches, edited grant proposals, coordinated revisions with multiple authors, and evaluated evidence-based articles for relevance to the Center’s projects in Boston’s Haitian and Latino communities.

Program and Outreach Director (Part-time: April – August 2011), Interim Associate Executive Director/Outreach Director (Full-time: April–August 2010)• Presided over operations including program development to support the coalition, legislative advocacy at the Massachusetts State House, community engagement and outreach throughout the state, and engaged directly in educational programs for patients and staff at 10 urban community health centers and 3 hospitals• Directed a crew of 10-15 volunteers for various fundraising events and included: directing participant registration, setting up and regulating the administration of silent auctions, and collecting/tracking funds received

• Worked independently with a C4-C5 quadriplegic and a patient with ataxia in their homes to assist with mobility and transfers, medications, bathing and grooming, dressing, passive range of motion (ROM) exercises, meal preparation, feeding and cleanup, toileting (bowel and bladder care), and other administrative tasks.

• Coordinated with Project Investigator and team on a pilot study at Dana-Farber Cancer Institute to gather information on lung cancer patient dyads (patient and family members) related to behavioral health patterns. Responsibilities included data collection, analysis, and creation of a poster presentation for various conferences.• Contributed to a literature review for an adolescent cardiovascular study coordinated with the University of Washington published in the Journal of Primary Prevention in 2012.

• Supported the Department Administrator and Gastroenterology and Nutrition staff in the coordinated care of new and long-term patients while attending Nursing school full-time• Served as liaison among doctors, patients, and insurance companies, organized/improved office record keeping systems, scheduled appointments across departments, collected/performed quality assurance before filing GPU sedation data for research purposes, and tracked/reported financial data for the department general and personal discretionary funds.

• Collaborated with the VP of Marketing and sales force to develop strategies to increase sales and brand recognition to promote Pilgrim’s Pride. Interfaced with the team to identify marketing opportunities and prioritized and managed their completion, including the creation of a consolidated Point of Sale and Point of Purchase program. Directed a crew of 10 – 15 to create and develop original trade show exhibits to expand our presence in the Latino markets throughout Texas, as well as organized statewide promotional events with the Texas Department of Agriculture, Ft. Worth Independent School District, and the Texas Department of Aging and Disability Services.

• Assisted in gathering information, analyzing processes, conducting research on external and benchmark information, and maintaining documents for project life cycle toward improving State Street’s financial and technical processes• Participated in the implementation of Oracle Financials at State Street by conducting interviews with senior level business unit managers at the State Street Boston, MA, Toronto, Canada, and Kansas City, MO, sites to gather technical and financial processes information to be used towards configuring the Oracle System on a global scale