Experience

iLS Clinical Research

• Mexico
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Independent Contractor, Senior CRA

  • Feb 2022 - Present



Caidya

• United States
• Biotechnology Research
• 400 - 500 Employee

• Independent Contractor, Senior CRA

  • Aug 2013 - Present

  Contractor Senior Clinical Research Associate Manages clinical investigative sites. Reviews and verifies that clinical documentation supports the protocol and protocol specific case report forms. Maintains drug accountability. Completes project specific monitoring site visit reports. Maintains accurate and timely sponsor/site correspondence and communication. Responds to audits and queries. Study Assignments - Peanut allergy - AML stems cells transplant Contractor Senior Clinical Research Associate Manages clinical investigative sites. Reviews and verifies that clinical documentation supports the protocol and protocol specific case report forms. Maintains drug accountability. Completes project specific monitoring site visit reports. Maintains accurate and timely sponsor/site correspondence and communication. Responds to audits and queries. Study Assignments - Peanut allergy - AML stems cells transplant



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Independent Clinical Research Associate

  • Jul 2021 - Nov 2021



Confidence Pharmaceutical Research

• United States
• Biotechnology Research
• 1 - 100 Employee

• Independent Contractor Senior CRA

  • Oct 2020 - Jan 2021



H Clinical

• United States
• Research
• 1 - 100 Employee

• Country Coordinator

  • Jul 2020 - Dec 2020



PAX Clinical

• Ciudad de México, México

• Contractor Senior CRA advisor

  • Jan 2017 - Sep 2020

  To provide services such as Site Monitoring and clinical research training. To provide services such as Site Monitoring and clinical research training.



AHRC, St. Michael Hospital

• Canadá

• Independent Contractor Senior CRA

  • Jul 2017 - Aug 2020

  Provide services such as: Manages clinical investigative sites. Reviews and verifies that clinical documentation supports the protocol and protocol specific case report forms. Maintains drug accountability. Completes project specific monitoring site visit reports. Maintains accurate and timely sponsor/site correspondence and communication. Responds to audits and queries. Study Assignment: • Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased XXXX Response after Percutaneous Coronary Intervention: TAILOR-PCI Show less



BLUE DUCK CONSULTING LTD

• United Kingdom

• Independent Contractor Senior CRA

  • Oct 2018 - Aug 2019

  To review the samples processing technic for the Blood biobank, to perform review of ICF for providing blood samples for genetic storage and analysis, to review regulatory documentation for local regulations. One site in Mexico City. To review the samples processing technic for the Blood biobank, to perform review of ICF for providing blood samples for genetic storage and analysis, to review regulatory documentation for local regulations. One site in Mexico City.



PSI CRO AG

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Independent Contractor Senior CRA

  • Jun 2015 - Jan 2019

  Provide services such as: Feasibility, Site Recruitment, Site Monitoring, Site Management, Audit, Regulatory Affairs, Document Management, Clinical Supplies Management, Safety Management, Vendor Management (local depot). Study Assignments A Phase III Study on the Safety, Pharmacokinetics and Efficacy of xxxx (xxxx) in Congenital Hemophilia A or B Patients from 6 months to less than 12 years of age with xxxxx. A Phase III Study on the Safety and Efficacy of Coagulation xxxx for the Prevention of Bleeding in congenital Hemophilia A or B Patients with xxxxx Undergoing Elective Surgery Show less



Emmes' Rare Disease and Pediatric Center

• United Kingdom
• Biotechnology Research
• 1 - 100 Employee

• Independent Contractor Senior CRA

  • Sep 2014 - May 2015

  The CRA is responsible for providing qualified professional consultans who have the necessary training, experience, background and licensure to provide those services as outlined in the work orders and in any other written materials, resources, directives or protocols provided to the CRA. The CRA is responsible to manages clinical investigative sites, Reviews and verifies that clinical documentation supports the protocol and protocol specific case report forms. Maintains drug accountability. Completes project specific monitoring site visit reports. Maintains accurate and timely sponsor/site correspondence and communication. Responds to audits and queries. Show less



Morley Research Consortium

• United States
• Research Services
• 1 - 100 Employee

• Independent Contractor, Senior CRA

  • Jul 2014 - Feb 2015

  Contractor Senior Clinical Research Associate. Provide monitoring services; including the management of clinical investigative sites. Reviews and verifies that clinical documentation supports the protocol and protocol specific case report forms. Maintains drug accountability. Completes project specific monitoring site visit reports. Maintains accurate and timely sponsor/site correspondence and communication. Responds to audits and queries. Site identification and regulatory documentation. Study Assignment Phase 1 A randomized, open-label, balanced, two-treatment, two-period. Two-sequence, single dose, two-way crossover oral food effect study comparing XXXXX/XXXXX immediate release tablets of XXX Pharmaceuticals in 28 healthy, adult, human subjects under fed (high fat high calorie breakfast) versus fasting conditions. Phase 1 A randomized, open-label, balanced, three-treatment, three-period, three-sequence, single-dose, crossover comparative oral bioavailability study of a XXXXXX/ XXXXXX immediate release tablets of XXX Pharmaceuticals XXX versus a XXXX (XXXXXXX) Tablets of XXXX Pharmaceuticals versus XXXXX tablets in 14 healthy, adult, human subjects under fasting conditions yielding a total evaluable population of 42. Show less



ICON plc

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Clinical Research Associate

  • Nov 2010 - Jan 2013

  Responsibilities include identification, selection, initiation, and close-out of appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP involvement, when required, in other areas of study management and staff training. Contribute to the review of ICON systems and procedures, as appropriate. Coaching and mentoring of monitoring competence to inexperienced/less experienced colleagues. Contribute to the culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. Recognize, exemplify and adhere to ICON’s values which centre around a commitment to People, Clients and Performance. Independently and proactively coordinate the necessary activities required to set up and monitor a study. Show less



PPD

• United States
• Research Services
• 700 & Above Employee

• Clinical Research Associate

  • May 2007 - Nov 2010

  Verify accurate source documentation and validate CRF entries, assisting with query resolution as needed. Assess investigational product accountability through physical inventory and records review. Visit investigative sites to assess facility/staff, implement protocols, and ensure site compliance with protocol specifications and regulatory obligations, doing recommendations as warranted Documentation observations in reports and letters in a timely manner using approved business writing standards. Review regulatory documents and maintain required files at the site and at PPD. Facilitate effective communication between investigative sites, the client company, and the PPD project team through written, oral and/or electronic contacts. Maintain and complete expense reports in a timely manner. Identify potential investigators in collaboration with the client company to ensure acceptability of qualified investigative sites. Respond to company, client, and federal regulatory requirements/audits. Contribute to the project team by mentoring new members, assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Show less



Instituto Nacional de Perinatología (INPer)

• Mexico
• Utilities
• 100 - 200 Employee

• Co-Investigator / Sub-Investigator

  • Aug 2005 - May 2007

  I participated in the Preeclamcia Prevention protocol we had, I did Patient pre-screening, screening, randomization, treatment and follow-up after delivery, as well as documenting all data collected during patients visits, also entering the data in the bata base and keeping this up to date. As Sub-I I participated in the Screening of more than 60 patients that meet eligibility criteria. I participated in the Preeclamcia Prevention protocol we had, I did Patient pre-screening, screening, randomization, treatment and follow-up after delivery, as well as documenting all data collected during patients visits, also entering the data in the bata base and keeping this up to date. As Sub-I I participated in the Screening of more than 60 patients that meet eligibility criteria.