Energetic and detail-oriented professional with strong background in healthcare management and team leadership. In-depth understanding of clinical processes and regulatory compliance, combined with proficiency in project management and strategic planning. Committed to driving operational efficiency and enhancing patient care outcomes.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Director of Clinical Operations
Flourish Research
11.2022 - Current
Streamlined patient enrollment process, increasing participant numbers in clinical trials without sacrificing quality or safety standards.
Ensured regulatory compliance by staying informed of industry standards and maintaining thorough documentation practices.
Oversee day-to-day clinical operations to ensure high-quality patient care.
Monitor patient flow, staffing levels, and utilization of resources to ensure smooth service delivery
Collaborate with other department leaders (e.g., finance, HR, IT) to align clinical operations with broader organizational goals.
Lead, mentor, and manage clinical operations teams, including nurses, clinicians, and other healthcare staff.
Ensuring compliance with all regional, GCP, and Federal code of Regulations for Research. Participating in Sponsor, IRB, and FDA Inspections
Clinical Operations Assistant Director
Suncoast Research Group, LLC
11.2021 - 11.2022
Responsible for assisting the Clinical Operations Director in overseeing and developing the organizations clinical departments through tasks such as hiring, evaluating, scheduling, supervising, and strategizing to allow for continued growth and provide clinical training to the staff
Assisting the Clinical Operations Director in maintaining and implementing standards of quality in all areas of the facility
Ensuring compliance with all regional, GCP, and Federal code of Regulations for Research
Participating in Sponsor, IRB, and FDA Inspections
Ensuring the excellent service and safety to all subject by the staff
Evaluating employees performance, monitoring compliance with legal regulations, and guidelines
Registered Nurse
Suncoast Research Group, LLC
11.2020 - 11.2021
Coordinate with Principal investigators, trial coordinators and research assistants to implement and dispense investigational products
Also works as Infusion Nurse and performs duties as Blinded/ Unblinded Pharmacist and Vaccinator
Duties include recruiting potential clinical trials participants as well as screening and enrolling, obtain Informed Consent, phone screening, obtain data directly from the subjects, schedule, conduct study visits, and perform procedures such as: electrocardiograms, vital signs, collecting, processing lab specimens also documenting lab results
Maintain the clinical investigational drug trials inventory; orders, replaces and returns study materials, as required
Communicates any concerns to the Sponsor and IRB as required
Education
Bachelor of Science - Nursing
Florida National University
Miami, FL
08.2020
Hialeah Gardens High School -
Hialeah Gardens High School
Hialeah, FL
07.2012
Skills
Collaborative skills
Effective written and verbal communication
Team Leadership
Attention to detail
Problem-solving abilities
Operational efficiency
Clinical Trial & Research Oversight
Risk Management & Patient Safety
Certification
Good Clinical Practice With Investigational Drugs and Medical Devices CITI Program
Basic CPR - 2024
Registered Nurse RN 9543228
Clinicalresearchexperience
Ocugen, Inc. - A Phase 2/3, Observer-Blind, Immuno-bridging, and Broadening Study of a Whole, Inactivated XXX-XX Vaccine (XXXX) in Healthy Adults
Merck Sharp & Dohme LLC - A Phase 3 Randomized, Double-blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of XXX When Administered Concomitantly with Influenza Vaccine in Adults 50 Years of Age or Older
Sanofi Pasteur Inc. - Safety and Immunogenicity of XXX XXXX XXX XXXX in Adults Aged 18 Years and Older
PFIZER - A PHASE 1, OPEN-LABEL STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF ORALLY ADMINISTERED XXX/XXX IN PREGNANT WOMEN WITH MILD-TOMODERATE COVID-19
ET HEALTHCARE - ET Healthcare COVID-19 OTC Home Use Antigen Self-Test Clinical Study
ZYDUS THERAPEUTICS, INC - A Phase 2b, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of XXXX XX in Subjects with Nonalcoholic Steatohepatitis and Fibrosis
BAVARIAN NORDIC - Evaluation of the Immunogenicity, Safety, and Tolerability of a Single Dose of XXXX Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2: a Phase 3 Trial in Two Parts—Randomized, Double-blind, Active Controlled and Open-label, Single-arm
GEORGE MEDICINES - Efficacy and safety of XXX compared to dual combinations for the treatment of hypertension
GEORGE MEDICINES - Efficacy and safety of XXX compared to placebo for the treatment of Hypertension
GlaxoSmithKline Research & Development Limited - A Phase III, Randomized, Multicenter, Parallel-Group, Double-Blind, Double-Dummy Study in Adolescent and Adult Female Participants Comparing the Efficacy and Safety of XXXX to XXX in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)
MODERNA TX, INC - A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity XXXX Vaccine in Adults Aged 18 Years and Older
MODERNA TX, INC - A Phase 3 Randomized, Observer-Blind, Study to Evaluate Safety, Tolerability, and Immunogenicity of XXXX, XXX Targeting Respiratory Syncytial Virus (RSV), When Given Alone or Coadministered with a Seasonal Influenza Vaccine or SARS-CoV-2 Vaccine in Adults ≥ 50 Years of Age
JANSSEN VACCINES & PREVENTION B.V - A Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of an XXX.XX-based Vaccine in the Prevention of Lower Respiratory Tract Disease Caused by RSV in Adults Aged 60 Years and Older
JANSSEN VACCINES & PREVENTION B.V - A Randomized, Double-blind Phase 3 Study to Assess the Immunogenicity and Safety of an XXXX.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years
JANSSEN VACCINES & PREVENTION B.V - A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of XX.XXXX for the Prevention of SARS-CoV2-mediated COVID-19 in Adults Aged 18 Years and Older
JANSSEN VACCINES & PREVENTION B.V - A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of XXX for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older
NOVARTIS - A randomized, placebo-controlled, participant-and investigator-blinded, sponsor open label study to evaluate the safety, tolerability, and efficacy with different dosing regimens of subcutaneously administered XXXXX in obese participants with or without type 2 diabetes mellitus
PFIZER- A PHASE 1/2 RANDOMIZED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A XXX XXX AGAINST INFLUENZA IN HEALTHY INDIVIDUALS
GLAXOSMITHKLINE - A study on the immune response and safety of the XXXX vaccine and the influenza vaccine when either is given to healthy adults at the same time or following a COVID-19 booster vaccine.
GENENTECH, INC - A PHASE IIb, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF XXX IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE
NOVAVAX, INC. - A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of a XXX-XX-X Recombinant Spike Protein Nanoparticle Vaccine (XXX) with XXX Adjuvant in Adult Participants ≥ 18 Years with a Pediatric Expansion in Adolescents (12 to < 18 Years)
ELI-LILLY- An Early Feasibility Study to Evaluate the Safety and Functionality of an Individual Accruing Data Algorithm with XXXX in Adult Participants with Type 2 Diabetes
Avalo Therapeutics, Inc. - A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of XXXX for the Treatment of Poorly Controlled Non-Eosinophilic Asthma
ELI-LILLY - A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain
Sanofi Pasteur Inc. - Immunogenicity and Safety of the First-in-Human XXXX Vaccine Formulation in Healthy Adults 18 Years of Age and Older
Pfizer - A PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF 2 REGIMENS OF ORALLY ADMINISTERED XXX/XXX IN PREVENTING SYMPTOMATIC SARS-COV-2 INFECTION IN ADULT HOUSEHOLD CONTACTS OF AN INDIVIDUAL WITH SYMPTOMATIC COVID-19
Pfizer - AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2/3, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED XXXX/XXX COMPARED WITH PLACEBO IN NONHOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19 WHO ARE AT INCREASED RISK OF PROGRESSING TO SEVERE ILLNESS
Novartis- A Phase I/III Randomized, Double-blind Study to Evaluate the Safety, Efficacy, and Neutralizing Activity of xxxxxx for Pre-exposure Prophylaxis of COVID-19 in Participants with Conditions Causing Immune Impairment
Boehringer Ingelheim- A Phase 3, randomised, double-blind, parallel-group, event-driven, cardiovascular safety study with xxxx administered subcutaneously compared with placebo in participants with overweight or obesity with established cardiovascular disease (CVD) or chronic kidney disease, and/or at least two weight-related complications or risk factors for CVD
NeuroBo- A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL, PHASE 2A CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF DA-1241 IN SUBJECTS WITH PRESUMED NON-ALCOHOLIC STEATOHEPATITIS (NASH)
SHIONOGI - A Phase 2, multicenter, randomized, double-blind, dose-ranging, placebo-controlled study to assess the safety and efficacy of xxxx in obese adults
MODERNA- A Phase 3, Randomized, Observer-blind, Active-control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of XXXX (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
Languages
Spanish
Native or Bilingual
Timeline
Director of Clinical Operations
Flourish Research
11.2022 - Current
Clinical Operations Assistant Director
Suncoast Research Group, LLC
11.2021 - 11.2022
Registered Nurse
Suncoast Research Group, LLC
11.2020 - 11.2021
Good Clinical Practice With Investigational Drugs and Medical Devices CITI Program
Basic CPR - 2024
Registered Nurse RN 9543228
Bachelor of Science - Nursing
Florida National University
Hialeah Gardens High School -
Hialeah Gardens High School
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