Registered Nurse Safety

CURRICULUM VITAE

Barbara Y. Valero, ARNP, FNP-C, MSN

Address: ***** ** ** ***

#106

Miami, FL 33015

Telephone: 786-***-****

E-mail Address: **************@*****.***

Current Position: Senior Clinical Project Manager

Clinical Pharmacology of Miami, Inc.

550 West 84th Street

Miami, FL 33014

2014 – Present

Prior Work Experience: Assistant Study Coordinator – Medical Assistant

Clinical Pharmacology of Miami, Inc.

550 West 84th Street

Miami, FL 33014

2009 – 2012

Clinical Research Technician

Elite Research Institute

Miami, FL 2008 – 2009

Intensive Care Unit Nurse Manager

National Hospital “Gustavo Aldereguia”

Cienfuegos, Cuba

1998 – 2007

Education: Nursing

Kaplan University - Miami, FL

2010-2012

International Training Careers

Certified Nursing Assistant

Miami, Florida

2008

Facultad de Ciencias Médicas de Cienfuegos

Licensed Nurse

Cienfuegos, Cuba

1993 – 1998

Certifications: Advanced Registered Nurse Practitioner (FNP-C)

Registered Nurse

Certified Nursing Assistant

Languages: English and Spanish

Position Responsibilities:

Administration of study drugs as required by the specific protocol

Conduct physical examinations

Ensures all study procedures are conduct as required by specific protocol (i.e. vital signs, draw blood, sample processing, sample shipping, etc.)

Assist in the management and reporting of adverse events, including serious adverse events

Assist in the administration of the informed consent

Notifies appropriate staff of abnormal results while collecting data, adverse events or unusual incidents

Assures minimal discomfort for study participants while performing all duties

Has knowledge of telemetry monitoring

Verifies that the water and supplies for dosing are set up on time per protocol specification

Verifies study procedure area is set up with all required equipment and supplies per protocol specifications

Assist with duties of taking temperature, weight, blood pressure, and pulse

Assist in performing a variety of routine blood drawing procedures to include venipuncture, techniques using standard equipment to include vacutainer tubes and sleeves, tourniquets, syringes and butterfly needles

Confer with patient to obtain information for laboratory records, explain procedures, allay fears and elicit cooperation

Verifies that the appropriate vials and containers necessary for specimen collection, depending upon tests ordered used

Maintains skills in the use of EKG machine, taking accurate vital signs

Assist staff and related medical staff with study participants care as requested, to include but not limited to, lifting patients, cardiopulmonary resuscitation, suctioning, bandaging, administering oxygen and other life saving measures as directed

When assigned, serve as Site Pharmacist or Assist Pharmacy Operations

Study History: Have served as Project Manager or Coordinator in the studies below:

"A Single Center, Randomized, Placebo-Controlled, Double-Blind, Single Ascending, Multiple Dose, AND a Cross-Over, Open-Label, Intravenous and Nasal administration Study to Evaluate the Safety, Tolerability and Pharmacokinetics of XXX in Healthy Subjects"

"A Phase 1, Open Label Study to Evaluate the Effect of Multiple Doses of XXX on the Pharmacokinetics of a Single Dose of XXX"

"A RANDOMIZED, OPEN-LABEL, PARALLEL GROUP STUDY TO EVALUATE PHARMACOKINETIC PROFILE, WEARABILITY AND SAFETY OF TWO XXX-ONLY PATCHES CONTAINING DIFFERENT DOSES OF XXX"

A Phase 1, Parallel-group, Open-label, Multiple-dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of XXX in Subjects with Severe Renal Impairment as Compared to Healthy Subjects with Normal Renal Function

An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of XXX in Patients with Renal Insufficiency

“Pharmacokinetics of XXX and XXX in Subjects with Mild to Severe Hepatic Impairment (Child-Pugh Classes A, B, and C), and in HCV- Seropositive Subjects, and in Healthy Volunteers”

An Open-label, Parallel-Group, Pharmacokinetic Study of Multiple Intravenous Doses of XXX and XXX in Subjects With Severe Renal Impairment and Normal Renal Function

A Single-Center, Randomized, Open-Label, 2-Way Crossover, Single-Dose Study to Evaluate the Bioequivalence of the Current Fixed-Dose Combination Formulation of XXX and XXX and the New Fixed-Dose Combination Formulation of XXX and XXX in Healthy Subjects

“A Single-Center, Open-Label, Multiple-Dose, 3-Way Crossover, Pharmacokinetic Drug-Drug Interaction Study Between XXX and XXX in Healthy Adult Subjects”

An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of XXX in Subjects with Normal Renal Function and Subjects with Mild, Moderate, Severe, and End-stage Renal Dysfunction

"A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of XXX in Subjects with Impaired Hepatic Function"

A Phase I, Open-Label, Single-Dose Pharmacokinetic and Safety Study of Oral XXX in Subjects with Mild and Moderate Hepatic Impairment and Healthy Subjects

A Phase 1, Open-label, Single-dose Study of the Pharmacokinetics, Safety, and Tolerability of XXX in Healthy Adults and Elderly Subjects and in Subjects with Impaired Renal Function

A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of XXX in Subjects with Impaired Renal Function

A Phase 1, Open-label, Single-dose Study of the Pharmacokinetics, Safety, and Tolerability of XXX in Subjects with Hepatic Impairment compared to Matched Healthy Subjects

A Phase 1 Open-Label, 2 Part, Parallel Group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of XXX

Phase 1 Randomized, Double-blind, Placebo-controlled Study of The Safety, Tolerability and Pharmacokinetics of Single, Ascending Oral Doses Of XXX in Healthy Volunteers

A Phase 1, Single-blinded, Randomized, 5-way Crossover Taste Assessment Study to Characterize the Palatability of Selected Formulations of XXX Compared to Formulation Controls in Healthy Adult Subjects

A Multi-Center, Randomized, Open-Label, Parallel, Multiple-Dose PK Study of XXX and XXX Following Administration of a Fixed Dose Combination of XXX and XXX in Healthy Subjects

“A Phase 1, Open-label, Randomized, Two-period Crossover Drug Interaction Study Evaluating the Effect of XXX on the Pharmacokinetic Profiles of Various CYP Probe Substrates in the Cooperstown Cocktail when Given to Healthy Adult Subjects”

The Relative Bioavailability of XXX Transdermal Systems (CTS) Compared to the Reference Product XXX)”

“An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of XXX in Patients with Impaired Hepatic Function"

A Phase 1, Multi-Center, Single-Period, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of XXX in Subjects who are Normal to Overweight and in Obese Classes I, II and III

Phase 1 Randomized, Double-Blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Repeat Administration (7 days) of Ascending Oral Doses of XXX in Healthy Volunteers

PHARMACOKINETICS OF XXX IN SUBJECTS WITH IMPAIRED RENAL FUNCTION

A Three-Part, Open-Label, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of XXX

Phase I Study to Assess the Effect of Severe Renal Impairment on the Pharmacokinetics of XXX

Phase I Study to Assess the Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics of XXX

A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of XXX in Subjects with Normal Renal Function and Severe Renal Impairment

A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of XXX in Subjects with Normal Hepatic Function and Moderate or Severe Hepatic

Impairment

"XXX Pharmacokinetics of XXX Following Administration to Subjects with Impaired Renal Function"

Pharmacokinetics of XXX in Subjects with Hepatic Impairment

“A Single-Center, Fixed-Sequence, Open-Label, 2-Period, Pharmacokinetic Interaction Study Between XXX and XXX in Healthy Subjects”

A Phase 1, Single-dose, Open-label Study to Determine the Pharmacokinetic, Safety, and Tolerability Profiles of XXX in Subjects with Normal and Impaired Renal Function

A Pharmacokinetic Study of XXX in Subjects with Hepatic Dysfunction

A Relative Bioavailability Study of XXX and XXX Transdermal System Patch

A Non-randomized, Single-dose, Open-Label, Pharmacokinetic Study of XXX in Patients with Impaired Renal Function and Subjects with Normal Renal Function

An open label, single-dose, parallel group study to assess the pharmacokinetics (PKs) and tolerability of a single oromucosal dose of 4 sprays of XXX and 10 mg XXX in patients with

A Phase 1, Open-label, Randomized, 3-period Crossover Study Evaluating the Relative Bioavailability of XXX When the Contents are Emptied into a Soft Food and Orange Juice in Healthy Adult Subjects

An Open-Label, Single-Dose Trial to Assess the Effects of Hepatic Impairment on the Pharmacokinetics of XXX

A Phase 1, Open-label, Randomized, 3-Period, Relative Bioavailability Study Comparing the Pharmacokinetics of XXX to XXX When Administered as XX Single Doses and Characterizing the Pharmacokinetic Profiles of XXX and XXX Administered as Two Different Dose Regimens in Healthy Adult Subjects

A Phase 1, Open-label, Randomized, Two-period, Crossover, Exploratory Study to Investigate the Effect of Food on the Bioavailability of a Single Dose of XXX in Healthy Adult Subjects

“AN OPEN-LABEL STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY PROFILE OF XXX IN MALE SUBJECTS WITH IMPAIRED HEPATIC FUNCTION”

“A SINGLE-DOSE, OPEN-LABEL STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY PROFILE OF XXX IN MALE SUBJECTS WITH IMPAIRED RENAL FUNCTION”

“Study to investigate the influence of age and gender on the pharmacokinetics of a single oral dose of XXX as immediate-release tablet in a randomized, double-blind, placebo-controlled, group-comparison design in healthy male and female …

A MULTIPLE SITE STUDY TO EVALUATE THE IRRITATION AND SENSITIZATION POTENTIAL OF REPEAT APPLICATIONS OF XXXTRANSDERMAL PATCH VERSUS XXX TRANSDERMAL PATCH IN HEALTHY VOLUNTEERS

A RANDOMIZED, CROSSOVER STUDY ASSESSING THE SINGLE DOSE PHARMACOKINETICS OF DELAYED-RELEASE XXX IN SUBJECTS WITH RENAL DYSFUNCTION

“A PHASE I, SINGLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, TWO-PART, SEQUENTIAL, SINGLE ASCENDING DOSE STUDY TO ASSESS THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF XXX IN HEALTHY SUBJECTS AND SUBJECTS WITH TYPE 2 DIABETES

“An Open-Label Study to Investigate the Pharmacokinetics of XXX and XXX in Subjects with Renal Insufficiency”

“A Single-Dose, Pilot, Comparative Bioequivalence Study of Two XXX Extended-Release XXX Capsule Formulations Compared to XXX Capsule, Administered under Fed Conditions, in Healthy Male and Female Subjects”

: “A Single-Dose, Two-Period, Two-Treatment, Two-Way Crossover Relative Bioavailability Study of XXX Tablets under Fed Conditions”

“A SINGLE BLIND, (SUBJECT AND INVESTIGATOR BLINDED, SPONSOR UNBLINDED), TWO-PERIOD, PLACEBO-CONTROLLED, RANDOMIZED, SEQUENTIAL, MULTIPLE ASCENDING DOSE STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF XXX IN

: “A Single-Dose, Two-Period, Two-Treatment, Two-Way Crossover Relative Bioavailability Study of XXX Tablets under Fed Conditions”

“An Open-Label, Single-Dose Relative Bioavailability Study of XXX, a Topical XXX Cream Versus Oral XXX in Healthy Male Adults”

“A DOSE ESCALATING, SINGLE BLIND STUDY TO DETERMINE THE TOLERABILITY AND PHARMACOKINETICS OF A SINGLE DOSE OF XXX IN HEALTHY VOLUNTEERS”

A Phase 1, Open-label Study to Investigate the Pharmacokinetics of XXX Administered to Severe and End Stage Renal Disease Patients not on Dialysis Compared to Healthy Matching Subjects

An Open-Label, Single Dose Study to Determine the Safety and Pharmacokinetics of XXX in Subjects with Impaired Renal Function and in Healthy Subjects with Normal Renal Function

A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of XXX in Subjects with Normal Renal Function and Severe Renal Impairment

Multiple dose trial examining dose range, escalation and efficacy of oral XXX in subjects with type 2 diabetes

A Phase 1, Randomized, Open-label, Crossover Study To Evaluate the Pharmacokinetic Interaction Between XXX and XXX in Healthy Adult Subjects

A Phase 1, Randomized, Open-label, Crossover Study to Evaluate the Pharmacokinetic Interaction Between XXX and XXX in Healthy Adult Subjects

A study to Investigate the utility of a stable isotope labeled XXX pulse chase technique to assess in vivo protein dynamics in healthy volunteers

An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of XXX in Subjects with Moderate and Severe Renal Insufficiency

A DOUBLE-BLIND CROSSOVER STUDY IN HEALTHY VOLUNTEERS TO COMPARE TWO FORMULATIONS OF XXX

A Single-Center, Fixed-Sequence, Open-Label, 2-Period, Pharmacokinetic Interaction Study Between XXX and XXX in Healthy Subjects

A fixed sequence trial investigating the interaction between XXX and the XXX

substrate XXX and the XXX substrate XXX

An Open-Label, Single-Center, Randomized, Two-Period, Two-Way Crossover Pilot Study to Compare the Bioequivalence of a Single Dose of XXX Extended-Release (ER) Capsules XXX with XXX capsules XXX in Healthy Adult Human Subjects, under Fasting Conditions.

An Open-Label, Single-Center, Randomized, Two-Period, Two-Way Crossover Pilot Study to Compare the Bioequivalence of a Single Dose of XXX Extended-Release (ER) Capsules XXX with XXX capsules XXX in Healthy Adult Human Subjects, under Fed Conditions.

AN OPEN-LABEL, SINGLE-DOSE STUDY TO EVALUATE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF XXX IN SUBJECTS WITH HEPATIC IMPAIRMENT

A Single-Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of XXX Extended-Release Capsule versus XXX Extended-Release 10 mg Capsule under Fasted Conditions

An Open Label Phase I Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Multiple-Dose Pharmacokinetics of XXX

A 2-Part, Open-Label, Single-Dose Study to Investigate the Influence of Hepatic

Insufficiency on the Pharmacokinetics of XXX

A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of XXX in Subjects with Chronic Hepatic Impairment Compared to Healthy Subjects

A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY EVALUATING THE SEXUAL FUNCTION OF HEALTHY ADULTS AFTER RECEIVING MULTIPLE-DOSE REGIMENS OF XXX, XXX OR PLACEBO

A Single-Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of XXX Extended Release Capsule versus XXX Extended Release XX Capsule under Fed Conditions

A 28-Day Safety Study to Evaluate the Safety and Tolerability of XXX

An Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Fixed Dose Combination Formulation of XXX, XXX and XXX in Subjects with Normal Renal Function and Subjects with Mild Moderate, Severe, and End-stage

A Single-Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of XXX Tablet versus XXX Tablet under Fasted Conditions

A Single-Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of XXX Tablet versus XXX Tablet under Fed Conditions

A MULTIPLE DOSE EVALUATION OF THE EFFECTS OF VARYING DEGREES OF HEPATIC IMPAIRMENT ON XXX PHARMACOKINETICS

A Phase 1, Open-Label, Randomized, 3-period Crossover Taste Assessment Study to Characterize the Palatability of XXX When the Contents are Sprinkled on to Soft Foods or Emptied into a Cup and Administered with Water in Healthy Adult Subjects

A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of XXX in Subjects with Impaired Hepatic Function

AN OPEN-LABEL, MULTIPLE DOSE STUDY TO ASSESS THE DRUG-DRUG INTERACTIONS OF XXX WITH CYTOCHROME P450 ISOENZYMES IN HEALTHY MALE SUBJECTS

AN OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, TWO-WAY CROSSOVER STUDY TO EVALUATE THE EFFECT OF FOOD UPON THE PHARMACOKINETICS OF XXX

A Multiple Site Study to Evaluate the Irritation, Sensitization and Adhesion Potential of Repeat Applications of XXX Transdermal System Patch Versus XXX Transdermal System Patch in Healthy Post-Menopausal Volunteers

A PHASE 1, OPEN-LABEL, SINGLE-DOSE STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY OF XXX IN SUBJECTS WITH MILD, MODERATE OR SEVERE HEPATIC IMPAIRMENT COMPARED TO HEALTHY SUBJECTS

A Phase 1 Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Single and Multiple Oral Doses of XXX in Healthy Young Adult Japanese Subjects and Elderly Non-Japanese Subjects

A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of XXX in Subjects with Impaired Renal Function

An Open-Label, Two-Way Crossover Trial to Assess the Biocomparability of Two Tablet Formulations of XXX After a Single Dose in Healthy Adult Subjects

“AN OPEN-LABEL STUDY TO EVALUATE THE EFFECT OF AGE UPON THE PHARMACOKINETICS OF XXX”

A Multiple Site Study to Evaluate the Irritation, Sensitization and Adhesion Potential of Repeat Applications of XXX Transdermal System Patch Versus XXX Transdermal System Patch in Healthy Post-Menopausal Volunteers

An Open-Label, Two-Way Crossover Trial to Assess the Biocomparability of a Capsule Formulation Compared to a Tablet Formulation of XXX After a Single Dose in Healthy Adult Subjects

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