Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
RESEARCH EXPERIENCE
Generic

Maria H. Candelario

Schertz,Texas

Summary

Personable and reliable, with strong foundation in clinical practices and patient care. Well-versed in regulatory compliance and data management, with solid grasp of clinical trial protocols. Dedicated to ensuring integrity and efficiency of clinical research projects and contributing to meaningful advancements in healthcare.

Overview

5
5
years of professional experience
1
1
Certification

Work History

Clinical Research Coordinator III

Tekton Research
05.2022 - 01.2024
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
  • Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
  • Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
  • Managed patient recruitment, informed consent process and data entry to support trial objectives.
  • 5 clinical trials; Birth Control, Children vaccine's.
  • Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.

Clinical Study Manager

Elligo Research
10.2020 - 06.2021
  • Mentored and trained research naive staff.
  • oversee the conduct of Moderna Covid Trial (MRNA Vaccine) with over 400 subjects.
  • Followed informed consent processes and maintained records.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
  • Gathered, processed, and shipped lab specimens.

Clinical Research Coordinator

Discovery Clinical Trials
04.2019 - 08.2020
  • Managed 5 research studies for multiple indications (Crohn's Disease, Ulcerative colitis, Low Testosterone, Cystic fibrosis's, Diabetes)
  • Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
  • Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Maintained accurate and up-to-date case report forms and source documents for traceability.

Education

High School Diploma -

Gabriela Mistral
Rio Piedras, Puerto Rico
06-1990

Certified Clinical Research Professional - Certificate

CCRP Certified - 2015 - 2018
01-2016

Skills

  • Good clinical practices
  • Informed consent
  • Informed consent process
  • Patient recruitment
  • Participant screening
  • Data collection
  • Electronic data capture
  • Documentation management
  • Adverse event reporting

Certification

Medidata

  • RAVE
  • Inform 6.0
  • ClinPhone
  • FlexAdvantage


Languages

Spanish
Native or Bilingual

Timeline

Clinical Research Coordinator III

Tekton Research
05.2022 - 01.2024

Clinical Study Manager

Elligo Research
10.2020 - 06.2021

Clinical Research Coordinator

Discovery Clinical Trials
04.2019 - 08.2020

High School Diploma -

Gabriela Mistral

Certified Clinical Research Professional - Certificate

CCRP Certified - 2015 - 2018

RESEARCH EXPERIENCE

  • Hypertension, Diabetes, NASH, PAD, Vaccines
  • In Hospital setting Device (Q-Pump)


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