Summary
Overview
Work History
Education
Skills
Certification
Clinicalresearchexperience
Languages
Timeline
Generic

Jennifer Ortega

Miami,FL

Summary

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
Jennifer Ortega