Summary
Overview
Work History
Education
Skills
Certification
Clinical Research Experience
References
Training
Timeline
Generic
ALBERTO NAPOLES ALVAREZ

ALBERTO NAPOLES ALVAREZ

Hialeah,FL

Summary

Dedicated Clinical Research Coordinator experienced in complying with study protocols, standard operating procedures and good clinical practices. Practiced problem-solver with strong attention to detail. Prepared to offer 8 years' experience in the field and take on a fast-paced position. Multi-talented clinical research professional proficient in handling patient information, laboratory samples and compliance procedures for different clinical trials. Well-organized and hardworking with excellent communication and planning skills. Current Bachelor in Nursing Degree. Multi-talented clinical research professional proficient in handling patient information, laboratory samples and compliance procedures for different clinical trials. Well-organized and hardworking with excellent communication and planning skills. Hardworking employee with customer service, multitasking and time management abilities. Devoted to giving every customer a positive and memorable experience. Motivated professional to adds value to any organization in need of great collaboration, interpersonal and multitasking abilities. Meets tight deadlines. Motivated to seeking internship in CRA position to gain hands-on experience with strong drive to succeed. with processional excellent research, technical and problem-solving skills. Detail-oriented and able to learn new concepts quickly.

Overview

12
12
years of professional experience
1
1
Certification

Work History

Clinical Research Coordinator III, Site Director

Kendall South Medical Center
Miami, FL
01.2024 - Current
  • Coordinate multiple phase 1, multiple cohort studies, while focusing on subject safety
  • Support Principal Investigator and Research leadership in designated research projects, study startups, and close out
  • Ensure all requirements of the protocol are met, while meeting compliance with regulatory standards and FDA requirements for each protocol
  • Maintain protocol compliance by being onsite for patient visits to ensure required procedures are completed and documented
  • Complete detailed documentation in strict accordance with regulatory requirements
  • Conduct meetings with CTN, and RA to establish a continuous working dynamic and ensure accountability and efficiency
  • Develop protocol-sourced documents, designs and reviews data forms used to track completed visits and protocol calendars
  • Recognize need for re-consenting as indicated and ensure completion by PI or study investigator
  • Collaborate with research staff, PI, and clinical staff to accurately report AE, SAE, and deviations in a timely manner to the IRB and sponsor
  • Create charts and tables to review stats and sociodemographic information for retention and future Collaboration.

Clinical Research Coordinator III, Phase I AD

Velocity Clinical Research Hallandale Beach
Hallandale Beach, FL
07.2019 - 01.2024
  • Coordinate multiple phase 1, multiple cohort studies, while focusing on subject safety
  • Support Principal Investigator and Research leadership in designated research projects, study startups, and close out
  • Ensure all requirements of the protocol are met, while meeting compliance with regulatory standards and FDA requirements for each protocol
  • Maintain protocol compliance by being onsite for patient visits to ensure required procedures are completed and documented
  • Complete detailed documentation in strict accordance with regulatory requirements
  • Conduct meetings with CTN, and RA to establish a continuous working dynamic and ensure accountability and efficiency
  • Develop protocol-sourced documents, designs and reviews data forms used to track completed visits and protocol calendars
  • Recognize need for re-consenting as indicated and ensure completion by PI or study investigator
  • Collaborate with research staff, PI, and clinical staff to accurately report AE, SAE, and deviations in a timely manner to the IRB and sponsor
  • Create charts and tables to review stats and sociodemographic information for retention and future Collaboration.

Certified Medical Assistant

Orthopedic Specialists of South Florida
Miami, FL
02.2015 - 07.2019
  • Created professional letters/templates for office wide usage of insurance authorization/appeals
  • Researched and activated a new software program office wide to increase productivity
  • Increased efficiency by co-creating and implementing a new scribing template
  • Collaborated with pharmaceutical representatives, pharmacists, and medical supply companies to increase patient satisfaction and compliance
  • Conducted peer-to-peer discussions with insurance companies
  • Advised MDs and MAs where to send pharmaceutical prescriptions and orders that would best benefit the patient
  • Researched and completed forms that would aid the patient in receiving biological medications at a more sustainable price
  • Confirmed patient's care and experience reflected our practice values
  • Served as a liaison between patient and clinic/pharmaceutical reps and clinic
  • Diffused any situation and made it my personal prerogative to ensure patient's expectations were met while still upholding the practice’s reputation and policies.

Medical Assistant

LAC-USC Medical Center
Los Angeles, CA
06.2012 - 02.2015
  • Participated in numerous breast cancer awareness community events in Los Angeles, CA area year-round
  • Single-handedly managed, prepared, and worked on a weekly expansion clinic with 25-45 patients in attendance
  • Completed thorough medical and medication history along with procedure and medication post-op teaching for an average of 20 patients a week
  • Managed, evaluated, and assisted in post-op procedures for 25-45 patients a week
  • Coordinated between hospital and facilities to increase efficiency of the office/surgery schedules.

Education

Bachelor of Science, Nursing - Bachelor’s in nursing

University of Sagrado Corazon, PR

Skills

  • Bilingual Spanish/English
  • Flexible, reliable, and dependable
  • Motivated self-starter with a fervent desire to learn
  • Great hand skills and quick learner
  • Proficient in Microsoft Word, Excel, PowerPoint, Cerner, CTMS, CRIO and EDC
  • Psychometric Rater
  • Research experience
  • Documentation requirements
  • Protocol development
  • Phlebotomy
  • Dispensing oversight
  • Specimen handling
  • Laboratory results management
  • Trial oversight
  • Case report management
  • Medication Dispensing
  • Scheduling proficiency
  • Schedule Coordination
  • Database organization
  • Meeting Coordination
  • Site Management
  • Report Preparation
  • Records Maintenance
  • Data Analysis
  • Good clinical practice
  • Documentation Management

Certification

  • CITI Program certification, Good Clinical Practice, Conflict of Interest, Biomedical Research Investigators & key personnel, Clinical Research Coordinator, 2019-Present
  • IATA –Dangerous Goods Transportation Certification, 2019-Present
  • American Heart Association CPR and AED certified (BLS), 2017-Present
  • EKG Competency Training Certification, 2019-Present
  • Psychometric Rater (CDR, ADAS-Cog, NPI, MMSE, CSSRS, MoCA, SASR, AIMS, BARS), 2019-Present
  • Fibro Scan Certification, 2019-Present

Clinical Research Experience

  • A phase II randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of orally administered XXXX during a 28-week treatment period as adjunctive therapy to antipsychotic treatment for the prevention of relapse in patients with schizophrenia., Jun-2020
  • Phase 2A, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of XXXXX in Parkinson's Disease Subjects with Motor Fluctuations., Aug 2020
  • Phase II/III: Double-Blind, Randomized, Placebo Controlled, Dose-Ranging Trial of XXXX for the Acute Treatment of Migraine., Dec-2020
  • Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of XXXX in Healthy Volunteers and Subjects with Alzheimer’s Disease., Jan-2021
  • A Phase 1 Randomized, Double-Blinded, Placebo-Controlled Single-Ascending-Dose Study of the Safety, Tolerability, and Pharmacokinetics of XXXX in Healthy Subjects and Subjects with Early Parkinson’s Disease., Mar-2021
  • XXXX: A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of XXX for the Treatment of Agitation in Subjects with Dementia of the Alzheimer’s Type, Apr-2021
  • XXX: MOMENTUM (Maximizing Outcomes in Treating Acute Migraine): A Randomized, Double-blind, Single-dose, Placebo-controlled Study to Assess the Efficacy and Safety of XXX (meloxicam and rizatriptan) for the Acute Treatment of Migraine in Adults., Jun-2021
  • XXXX: An Open-Label Study to Assess the Long-term Safety of XXXX (meloxicam and rizatriptan) for the Acute Treatment of Migraine in Adults., Aug-2021
  • XXX: MOMENTUM-2 (Maximizing Outcomes in Treating Acute Migraine - 2): A Randomized, Double-blind, Single-dose, Placebo-controlled Study to Assess the Efficacy and Safety of XXX (meloxicam and rizatriptan) for the Acute Treatment of Migraine in Adults., Sep-2021
  • XXXX: A Phase 2, double-blind, randomized, placebo-controlled crossover study evaluating the effect of XXXX on gait and balance in subjects with Alzheimer’s Disease, Dementia with Lewy Bodies, or Parkinson’s Disease Dementia., Sep-2021
  • A Phase 3, double blind, randomized study of XXXX versus placebo when added to existing stable donepezil treatment in subjects with mild to moderate Alzheimer’s disease; XXXX
  • A Long-Term, Open-Label Extension Study of the Safety and Tolerability of XXX in Subjects with Alzheimer's Disease; XXX., Nov-2021
  • A Study to Evaluate XXXX in Subjects with Mild Cognitive Impairment Associated with Parkinson's Disease
  • XXXX: A Double-Blind, Placebo-Controlled, Randomized withdrawal, Multi-Center Clinical Trial Evaluating the Efficacy, Safety and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Patients with Schizophrenia, Jan-2022
  • A Double-Blind, Cross-Over Placebo-Controlled and Active-Controlled Trial to Evaluate the Effect Of A Supratherapeutic Dose Of MK-8189 On The QTc Interval In Participants With Schizophrenia., 2023
  • An Open-Label, Single-Arm, Phase 4 Study to Assess Glycemic Control When Adults with Type 2 Diabetes Switch from a GLP-1 RA to Tirzepatide (SURPASS-SWITCH-2), 2023
  • A Phase 3b, Randomized Controlled Study to Evaluate the Efficacy and Safety of Tirzepatide Compared to Semaglutide 2.4 mg in Adults Who Have Obesity or Overweight with Weight-Related Comorbidities (SURMOUNT-5), 2023
  • A Phase 2a/2b Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of MK-1942 as Adjunctive Therapy in Participants with Mild to Moderate Alzheimer’s Disease Dementia., 2023
  • A Phase 2a, Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-1942 Added to Stable Antidepressant Therapy in Participants with Treatment-Resistant Depression., 2023
  • A randomized, observer-blind, active-controlled Phase 3 study to investigate the safety, immunogenicity, and relative vaccine efficacy of mRNA-1283.222 administered as a booster dose compared with mRNA-1273.222 in participants aged 12 years and older for the prevention of COVID-19., 2023
  • A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 52-Week Study Evaluating the Safety and Efficacy of Simufilam 100 mg Tablets in Subjects with Mild-To-Moderate Alzheimer's Disease., 2023

References

  • Yasmany Beitra, CRA II, IQVIA, Yasmani.beitra@iqvia.com, 305-467-2568
  • Juliet Vento, MD, Velocity Clinical Research, jvento@velocityclinical.com, 305-915-0437
  • Maritza Berliner, Sr. CRA Clinical Operations, ICON dedicated to Merck, Maritza.Berliner@merck.com, 305-926 7350
  • Patricia Pedrezzetti,Complaince Manager,Thermo Fisher, patricia.pedrezzetti@ppd.com,919-456-8528

Training

Rethink ALZ PTI-125-07 Investigator Meeting, November 5 & Saturday, November 6, 2021, in Atlanta, GA.

Timeline

Clinical Research Coordinator III, Site Director

Kendall South Medical Center
01.2024 - Current

Clinical Research Coordinator III, Phase I AD

Velocity Clinical Research Hallandale Beach
07.2019 - 01.2024

Certified Medical Assistant

Orthopedic Specialists of South Florida
02.2015 - 07.2019

Medical Assistant

LAC-USC Medical Center
06.2012 - 02.2015

Bachelor of Science, Nursing - Bachelor’s in nursing

University of Sagrado Corazon, PR
ALBERTO NAPOLES ALVAREZ