EDUCATION

• Master of Science, Clinical Research Management (MS-CRM), Arizona State (2012)

• Bachelor of Science, Nursing (BSN), University of Phoenix (2007)

• Associate of Science, Nursing (ADN), Pima Community College (1998)

APPLICABLE RESEARCH CERTIFICATIONS

• Citi Human Subject Training • Human Protections Informed Consent

• Ethics in Action in Clinical Settings • Trauma Nurse Core Course

• Level-I AZ-IVP Fingerprint Card

• CRA-Monitor’s ICH/GCP course

• NIH Research Certification

• TSA Pre-Check Traveler Number (KTN)

IT SKILLS:

• Proficient with: MS-Office and Mac OSX-Office programs, also experienced using:

• Oracle Clinical Data, Medidata Rave, and Medrio Electronic Data Capture (EDC)

• Insperity - Expense report apps, tools, and Cloud data management.

STATISTICS SKILLS

• Statistical analysis, random error safeguard plans

• Presentation of statistically significant outcomes/endpoints

• Statistical sampling methods

• Randomization and SPSS

• Inference data in Analyses of Variance (ANOVA)

• Methods for randomization

RESEARCH SKILLS

• Clinical research project and data management

• Global clinical trial operation trends

• Regulatory requirements for healthcare-regulated development

• Clinical research process improvement techniques

• Cost effectiveness analysis

• International, federal, state and local regulations guiding clinical research

• Institutional Review Board (IRB) requirements and conduct of ethical research

• FDA and IRB communication

• Data Management

• Protocol/Grant writing

• Clinical research study designs involved the development of new drugs and devices, biologics, vaccines

and other medical related consumer products

PROFESSIONAL CLINICAL WORK EXPERIENCE

Naurex Inc., Regional CRA Monitor (Feb 2014 – Feb 2015)

STUDIES INVOLVED (see “a-c” below)

a. Phase 2, Randomized, Double Blind, Multi-Dose Level, Placebo-Controlled, Single Intravenous Dose,

Parallel Efficacy and Safety Study of NRX-1074 in subjects with Major Depressive Disorder.

b. Phase 1, A Randomized, Double Blind, Placebo-Controlled Single Intravenous and Oral Ascending

Dose Study of the Safety, Tolerability and Pharmacokinetics of NRX-1074 in Normal Healthy

Volunteers

c. Phase 1, A Randomized, Double Blind, Placebo-Controlled Single Intravenous Dose, Ascending Dose Level Study of the Safety, Tolerability and Pharmacokinetics of GLYX-13 in Healthy Volunteers.

Coordinator Intern, shadowed Site Director, Wichita KS, PRN of Kansas Spring (Fall 2012)

• Filed form 1572s, financial disclosures, CVs, licenses, IB, IP receipts/tracking, e-CRF/source documents

and lab manuals

• Data management and archive of regulatory binders at closeout

• Achieved familiarity with active randomized, blinded, crossover-adaptive protocols

• Active with investigator-participant coordination and recruitment

• Thesis plans for potential PhD work

• Reached out to CRO's communicating interest in bringing new studies on site

• Discussed budgets, regulatory, ethical and adjudication processes related to managing and identifying

serious unexpected adverse events, and adverse event reports captured, learned during research studies

• Practiced strong business and financial acumen

Clinical Research Coordinator, Tucson, AZ-Clinical-Research-Center, (Fall 2008)

• Mastered many clinical exercises during trials, audit source documents, negotiate with monitors, query

reconciliation, phlebotomy, Informed consent, binders and regulatory management, participated with

arthritis, medical device, COPD, and hypertensive agents under study, worked collaboratively, and liaised

closely with physicians, nurse practitioners.

GRAND CANYON UNIVERSITY, Tucson campus (Fall 2007)

Adjunct faculty intern, Part time employ

• Teach/evaluate 10-15 students’ clinical skills useful to Bachelor Science nurses (BSN) administering nursing practice

• Discussed useful clinical skills allowing this teacher to educate learners, test technique and provide teaching as needed to facilitate-guide prompt-effective skill acquisition.

CORRECTIONAL MEDICAL, Tucson, Arizona (Aug 2006-Sept 2007)

Corrections nurse,

• Triage care at inmate arrival

• Administer referrals to other services as needed.

• Administer admit paperwork upon admit to jail

• Evaluate medical history/care requirements for acute needs

• Safely-supervised med-clinic

•Nurse sick call and med-infirmary

• Improved critical thinking skills/autonomy

• Operated via Standard-Operating-Procedural protocol (via algorithm use) and decision tree to ID certain manifestation/complaint criterion,

• Liaised with providers to provide optimal inmate safety, providing health teaching

PREFERRED HOME CARE, Tucson, Arizona (Nov 2004-Aug 2006)

Home infusion nurse,

Duties & Skills:

• Achieved excellence educating clients

• Achieved independence with home IV skills

• In-home extension of providers’ ability

• Succeeded with outpatient/hospital teaching

• Educated clients. teaching IV control, flow, infection control, routine saline and/or heparin flush

• Independent lab collection, venipuncture and lab value monitoring

TUCSON HEART HOSPITAL, Tucson, Arizona (May 2004–Nov 2004)

Telemetry nurse

• Carefully assessed neurological indicators

checking patients for signs of blood clots

• Examined computerized lab test results

following post dialysis, colonoscopies, and

surgeries

• Delivered broad range of nursing care in area

of vital signs, electrocardiogram, phlebotomy,

and catheters,

Feeding tubes, IV, central and arterial lines

• Prioritized/managed care

• Determined patient coagulation times to

identify need for therapy changes

• Monitored side effects of medications,

demonstrating strong observation skills.

• Managed care for up to six patients,

disseminating health teaching as applicable for

new illness

• Responded to emergencies

• Admitted/discharged angiogram educating

clients regarding risks to observe for, post

discharge.

• Collected arterial clotting times for Cordis

stasis

• Monitored/cared for arterial Cordis in place

• Managed support staff, providing continued

education as applicable

• Initiated conscious sedation during trans-

esophageal echocardiogram

• Initiated & maintained intravenous sites

• Administered surgical asepsis with wet-to-dry

dressings, intravenous care & catheterization

• Liaised closely with interdisciplinary health

Recommendations available upon request

DENVER HEALTH (DHMC), Denver, CO (Sept 2002 – April 2004)

Trauma/Tele-Nurse

• Documented patient assessments

• Responded to emergencies

• Consulted providers with

managing patient care

• Completed critical

care/trauma internship

• Managed care for up to six

patients providing continued

health teaching as necessary

• Administered blood

• Initiated venous cannulation

• Interpreted EKG

• Collected 12-lead EKG

• Directed support staff

• Monitored chest tube

output, alerting urgent

findings to provider

• Consented patients for

blood transfusion

• Monitored serial blood labs,

to identify hemorrhage

• Initiated surgical asepsis for

wet-to-dry dressing,

intravenous care & urinary

catheterization

• Liaised closely with

interdisciplinary health care

team for optimal care

• Completed nurse internship into the Surgical Intensive Care Unit

• Directed useful skills when

teaching junior nurse

• Supervised support staff in

team-approach

• Dealt with inexperienced &

nervous interns with tact

diplomacy

• Initiated & maintained

intravenous access

20YRS ALLIED HEALTH {earlier work truncated for space)

Retain Master’s graduate for admin-oversight of clinical drug-device trials, regulatory planning, protocol writing, IRB/FDA approval pathway planning, and participant informed consent-ethical conduct guidance, ICH-E6-GCP. Formal studies provided fundamental-operational expertise for globally acceptable ideologies of ethics critical to effectively guide research conduct expectation during investigation. Expertise of focus: Clinical monitoring (tailored-to-study phase), recruitment goals, and smooth-accurate flow of data, Investigator encouragement, and CRF management, serving as sponsor’s contact. Courses emphasized current-acceptable principles: ICH/GCP. Lessons fostered professional investigator identity, autonomy, and accountability-effective management of serious adverse expected and/or emergent-unexpected adverse events requiring immediate advisory to stakeholders. Regulatory skills emphasized oversight of Health and Human Services Common Rule regulatory guidance, unwavering protocol adherence, data accuracy, source document verification, recruitment-retention plans, site selection, start-up, closeout, interim monitoring, and summary reports. Trained for corrective preventative action strategies, teaching-training study personnel; manage common electronic data capture resources, electronic Case Report Forms and E-Diaries; prompt post visit report writing, health-research language proficiency, inspirational-transformational leadership skills.

RESEARCH Cert’s

• Citi Human Subject Training

• Human Protections Informed Consent

• Ethics in Action in Clinical Settings

• National Institute of Health Research Training Certificate Clinical research study design planning for development of new drugs, medical devices, biologics, vaccines, and

other medical related consumer products

• Clinical research project-data management

• Trends in global clinical trial operations

• Regulatory requirements for healthcare reregulated

product development

• Clinical research process improvement

techniques

• International, federal, state, and local

regulations guiding clinical research

• Institutional Review Board (IRB) needs and

conduct of ethical research

• Cost effectiveness analysis

• Fiscal aspects of the clinical trial global

industry

• Perform routine site visits, including pre-study,

initiation, interim, and closeout visits

• Performed duties with minimal support from management. Visits included monitoring proper informed consent procedure, compliance with protocol, GCP/ICH guidelines, other regulatory requirements, and assurance of good site performance, accomplished by detailed review of subject records, essential documents, investigational product disposition and accountability, site

personnel and procedures

• Manage assigned sites by regular contact to ensure site compliance, adequate enrollment, and understanding of study requirements

• Author monitoring report and follow-up

letter within the project-specific timelines

• Significant issues noted, reported to appropriate personnel immediately

• Principal Investigator (PI) selection

• CAPA, oversight of enrollment, data flow

• SDV, Trend observation, data integrity, protocol adherence, deviation audit, and Phase-based monitor plans, data reconciliation, clean, archive, close out.

• Responsible Conduct for Research

• Innovation and the Individual

• Clinical Research Management & Regulatory Affairs

• Research Design and Methods for Research

and Regulatory Science

• Applied Cost-Effectiveness Analysis in Intervention Research

• Data Management •Technology Implementation

• Clinical Research Op’s

• Biostatistics

• Health-Project Management

• Good Clinical Practices

• Medical Ethics,

• Medical Terminology

• Drug-Device Development

• US FDA 21 CFR

• Int’l ICH regulations

• Documents, Protocols

• FDA Form 1572

• Institutional Review Boards

• Clinical Investigator Qualification Visits

• Drug-Device

Accountability

• Human Subject Rights,

Safety-Protection

• Monitoring Visit Process

• Site Initiation

• Data Management

• Report Writing

• Close-Out Meetings

• Adverse Event Handling

• Trauma nurse core course

• English-Spanish speaker

• Study start up, staff GCP, and conduct training.

Contact this candidate