Rodriguez_CV_May2015-General_Redacted

Monica C. Rodriguez, RN, CCRP Clinical Research Nurse

Portland, OR 97229 Phone: 415.246.9194 Email: [email protected]

PROFILE

As a strong clinical nurse with diverse experience, I have been able to successfully utilize these skills in clinical research. Clinical proficiency, leadership, strong administrative skills, resourcefulness, assertiveness and drive has allowed me to significantly contribute to the development of two major clinical research programs. I have served on several sponsor coordinator steering committees and take every opportunity that is offered. Where opportunities do not exist, I create them for myself.

My goal is to find a position in a high-acuity clinical research program, or to transition my clinical expertise and research site-level experience to sponsor or CRO opportunities.

EXPERTISE > Strong Clinical Understanding > Critical Care > Stroke > Liver Transplant > Neurosurgery > Regulatory > Project Management > SOPs > Grants > Sponsored, NIH and

investigator- initiated trials

EXPERIENCE Providence Brain and Spine Institute

Clinical Research Nurse, Institute Wide Lead Research Coordinator Stroke, Neurosurgery, Neurocritical Care, ALS

Portland, OR, February 2011 - Present

Responsibilities include, but not limited to: Management of all stroke and neurosurgery trials (including procurement, startup and implementation), regularly supporting up to 40 investigators. Assignment and supervision of non-RN coordinators. Screening, enrollment of high-acuity clinical trials including ischemic stroke (drug, genomics, and registries), large-vessel ischemic stroke (device), ICH (drug & surgical intervention; intraventricular, intraparenchymal, hypertensive), TIA (drug), carotid stenosis (carotid stent device), and aneurysm (neuroendovascular device registries, intracranial specimen banking registry); 14 months interim ALS research nurse (neuro and pulmonary function testing). Cultivated cohesive relationships with members and managers in the following departments of two hub hospitals: ICU, neuro floor, ED, CVL, OR, MRI, CT, Pharmacy, HIM, others. Regulatory submissions, compliance and SOP creation. Instrumental in 5-state-wide Epic system implementation of research application, including creation of study drug addition to system-wide formulary, creation of complicated order sets, training protocols for all RN and non-RN research coordinators, compliance and optimization; ongoing regional optimization committee member. Program development and leadership of region’s largest stroke center (Comprehensive Stroke Center accredited) in all stroke research protocol clinical training, regulatory compliance, budgets and contract involvement, frequent IRB presenter. Lead for monthly and PRN program level research meetings. Project manager for two nationwide, $1 million + NIH grant submissions, including involvement and coordination of > 20 regional telestroke sites, as well as multiple smaller, private grants. Editing, formatting and submission of investigator neurosurgery publications. Department-wide “go to person” for IT, administrative issues, and EMR issues; MS Office proficient, PDF form creation, multiple EDC systems. Specimen collection, processing and shipping.

Providence Portland Medical Center

Clinical Documentation Nurse Specialist

Portland, OR, August 2010 – February 2011

Intermediary between hospital coders and physicians for accurate and appropriate diagnoses documentation, to ensure the greatest reimbursement allowable and appropriate. Medicare Severity DRGs, ICD-9, strong clinical understanding of anatomy, physiology and pathology.

University of California, San Francisco (UCSF)

Clinical Research Nurse, Liver Transplant; Post-Liver Transplant Coordinator (Standard of care), Critical Care Nurse (1st year)

San Francisco, CA, November 2005–October 2010

Responsibilities include, but are not limited to: Screening, enrollment of high-acuity, high-enrolling Liver Transplant and Kidney Transplant clinical trials. “Standard of care” post-transplant care coordination of all recipients enrolled in clinical trials: coordination and interpretation of frequent lab work, diagnostic procedures, medication adjustments (immunosuppressant, antibiotic, etc.).Infusions, study medication dosing (intraoperative, CRC, inpatient, outpatient). Specimen collection/processing/shipping, Supervision of multiple research assistants and non-RN coordinator. Frequently study-wide high enrollers. One year in high-acuity Medical Surgical ICU, multiple services.



S

PROFESSIONAL

SKILLS > Excellent phlebotomy and IV skills,

ECG, PFTs

> Strong computer skills

> Logistics

> Public speaking, presentations

> Team member empowerment

> Team building

> Training (investigator, coordinator, staff)

PERSONAL SKILLS > Resourcefulness

> Assertiveness

> Problem solving

> Reference materials

SOFTWARE > Microsoft Office proficient

> Adobe Suite, PDF fillable forms

> Epic Systems, Centricity, Physician Portal, STOR,

> Multiple EDC systems (Oracle, Vision, RAVE, DataTrak, Ceftriax, InForm, more)

> Velos, Study Manager

LANGUAGES > English: Fluent

> Spanish: Intermediate

INTERESTS > My dogs

> Painting

> Cooking (potluck food!)

> Gardening

> Salsa dancing

EXPERIENCE (continued)

University of California, Los Angeles (UCLA)

Critical Care Nurse

Los Angeles, CA, May 2003 – November 2005

High-acuity solid organ transplant medical/surgical ICU, pre and post-transplant. CVVHD, invasive cardiac monitoring, inotropic and vasogenic agent titration, heavy blood products infusion, complicated wound care, frequent encephalopathy and coagulopathy, immunosuppressant management, more.

Surgical Technologist (Scrub Tech)

US Air Force (Ohio, Germany and Los Angeles) 1993 - 2003

Multiple main operating rooms and surgery centers.

EDUCATION

UCSF Clinical Research Coordinator Training Course Los Angeles, CA 2004

UCLA Critical Care Course Certificate Los Angeles, CA 2004

LA County College of Nursing and Allied Health Associate Degree in Nursing Los Angeles, CA 2003

CERTIFICATIONS, LICENSURE

>Oregon RN license # 201042183 >California RN License # 627099 (inactive) >Texas RN License # 714953 (inactive) >SoCRA CCRP # 41943 >BLS >NIHSS

>Modified Rankin Assessment >IATA >NEALS >CSSR-S >CITI, Group 1, GCP

REFERENCES

Excellent references available upon request.



RESEARCH TRIALS STROKE AND NEUROSURGERY

NCT02072226 Kansara (PI) February 2015 – Present A Study of the Efficacy and Safety of Activase (Alteplase) in Patients With Mild Stroke (PRISMS), Genentech, NETT, Providence Brain and Spine Institute. PRISMS is a double-blind, multicenter, randomized, Phase IIIb study to evaluate the efficacy and safety of intravenous (IV) Activase in patients with mild acute ischemic strokes that do not appear to be clearly disabling. Role: Lead Study Coordinator NCT02239640 Deshmukh (PI) December 2014 – Present Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke (STRATIS) Registry, Covidien/Medtronic, Providence Brain and Spine Institute. The purpose of this registry is to assess outcomes associated with the use of devices intended to restore blood flow in patients experiencing acute ischemic stroke. Role: Lead Study Coordinator NCT01955707 Lowenkopf (PI) December 2013 – Present Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke (ACTION), Biogen Idec, Providence Brain and Spine Institute A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Safety and Efficacy of Intravenous Natalizumab (BG00002) on Reducing Infarct Volume in Acute Ischemic Stroke. Role: Lead Study Coordinator NCT01827046 Antezana (PI) November 2013 – Present Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III (MISTIE III), Genentech, Johns Hopkins University, Daniel Hanley A phase III, randomized, case-controlled, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage (ICH). Role: Lead Study Coordinator NCT01657461 Deshmukh (PI) December 2013 – February 2015 Solitaire™ FR as Primary Treatment for Acute Ischemic Stroke (SWIFT PRIME), Covidien Neurovascular, Providence Brain and Spine Institute Role: Lead Study Coordinator NCT00991029 Kansara (PI) November 2013 - Present Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial, NINDS, NETT, Providence Brain and Spine Institute Role: Lead Study Coordinator NCT00784134 Antezana (PI) July 2009 - Present Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III), Johns Hopkins University, NINDS, Providence Brain and Spine Institute Role: Lead Study Coordinator NCT01176565 Lowenkopf (PI) January 2011 - July 2016 Antihypertensive Treatment in Acute Cerebral Hemorrhage-II (ATACH-II), University of Minnesota, NINDS, Providence Brain and Spine Institute. A pragmatic, streamlined randomized design to evaluate the efficacy of intensive SBP reduction and its effect on outcomes measures at 24 h and at 3 m from randomization in subjects with ICH Role: Lead Study Coordinator NCT00389181 Deshmukh (PI) October 2006 - July 2017 A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA) The purpose of this study is to determine if medical management is better than invasive therapy for improving the long-term outcome of patients with unruptured brain arteriovenous malformations, Columbia University, NINDS, Providence Brain and Spine Institute Role: Lead Study Coordinator NCT00526474 Lowenkopf (PI) September 2007 - Dec 2011 Trial to Assess the Effects of SCH 530348 in Preventing Heart Attack and Stroke in Patients With Atherosclerosis (TRA 2°P - TIMI 50) (Study P04737AM3); Schering-Plough, Providence Brain and Spine Institute Role: Lead Study Coordinator NCT01444664 Deshmukh (PI) July 2013 – January 2015 Aneurysm Wall Histology Registry, Medical University of South Carolina, Microvention; Providence Brain and Spine Institute Role: Lead Study Coordinator



RESEARCH TRIALS (continued) ALS NCT01709149 Goslin (PI) January 2013 – August 2014 Study of Safety, Tolerability & Efficacy of CK-2017357 in Amyotrophic Lateral Sclerosis (CY4026) NEALS, Cytokinetics, Providence ALS Center Role: Lead Study Coordinator NCT01806857 Goslin (PI) January 2013 – August 2014 Clinical Trial Nuedexta in Subjects With ALS Center for Neurologic Study, La Jolla, California; NEALS, ALS Association, Providence ALS Center Role: Lead Study Coordinator NCT01622088 Goslin (PI) January 2013 - May 2013 Phase 3 Extension Study of Dexpramipexole in ALS (ENVISION) Biogen Idec, Providence ALS Center Role: Backup Study Coordinator LIVER AND KIDNEY TRANSPLANTATION NCT00555321 S. Feng (PI) November 2007 - September 2010 Belatacept in Liver Transplant Recipients, Bristol Meyers Squibb, UCSF Medical Center Role: Lead Study Coordinator NCT00622869 S. Feng (PI) February 2008 - September 2010 Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients (RAD), Novartis, UCSF Medical Center Role: Lead Study Coordinator NCT00135694 S. Feng (PI) November 2005 - July 2010 Gradual Withdrawal of Immune System Suppressing Drugs in Patients Receiving a Liver Transplant (AWISH) NIAID, ITN, UCSF Medical Center Role: Secondary Study Coordinator NCT00260208 J. Roberts (PI) November 2005 - July 2010 Liver Fibrosis in Patients Transplanted for Hepatitis C Receiving Either Cyclosporine Microemulsion or Tacrolimus (REFINE) Novartis, UCSF Medical Center, Role: Lead Study Coordinator NCT00118742 J. Roberts (PI) November 2005 - July 2010 Liver Spare the Nephron (STN) Study, A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant Hoffman-LaRoche, UCSF Medical Center Role: Lead Study Coordinator NCT00979251 J. Roberts (PI) September 2009 - July 2010 Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects (PO206) Adamas, UCSF Medical Center Role: Lead Study Coordinator NCT00772148 S. Feng (PI) October 2008 - July 2010 Pharmacokinetics of LCP-Tacro™ Once Daily and Prograf® Twice A Day in Adult De Novo Liver Transplant Patients Lifecycle, Veloxis, UCSF Medical Center Role: Secondary Study Coordinator NCT00531856 S. Feng (PI) September 2007 - July 2010 Safety and Tolerability Study of Inhaled Carbon Monoxide in Kidney Transplant Patients (Covox™) INO Therapeutics, UCSF Medical Center Role: Lead Study Coordinator NCT00166556 J. Roberts (PI) November 2005 - July 2010 Trial to Assess Campath-1H and Tacrolimus Followed by Immunosuppression Withdrawal in Liver Transplantation Enzon, UCSF Medical Center Role: Secondary Study Coordinator

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Rodriguez_CV_May2015-General_Redacted