Charresse H.

About Charresse H.

A Senior Clinical Research Associate with 5 years of site management experience, specializing in CTMS, EDC, regulatory compliance, and SAE reporting. A proven track record of collaborating with multidisciplinary teams to execute complex clinical research initiatives.

Experience

1. Senior Clinical Research Associate

   IQVIA

   Oct 2021 — Present

   Participates in the development, execution, completion, and reporting of clinical trial(s) according to the regulations, on time and within budget.• Assists in drafting study related documents (protocol, informed consents).• Assists in start-up activities of clinical studies including Investigator Meetings, selection of trial sites and investigators.• Assists in managing CRO\'s/ FSPs under the direction of study managers.• Attends co-monitoring visits as needed.• Reviews monitoring visit reports from CRO/FSP.• Ensures the management and tracking to timely resolution of deficiencies identified via monitoring, auditing, project calls and updates or other sources.• Understands and works to a risk-based approach, prioritizing the safety and welfare of human trial participants.• Writes, reviews, and / or provides input to study plans and guidelines.• Manages trial related materials and vendors, e.g. investigational product supplies, ancillary supplies, central laboratories, central IRB, etc. as assigned.• Assists with the electronic trial master file (eTMF) processes including set-up and QC.• Ensures the quality control of critical documents.• Collaborates with CRO/FSP counterpart on an ongoing basis.• Performs monitoring (PSV, SIV, IMV, COV), as needed, of a clinical trial(s) in accordance with the company (or other applicable) SOPs, ICH E6 GCP, and other regulations and guidance as relevant.

Education

• University of Houston

  Psychology, Bachelor of science

• Indiana Institute of Technology

  Master of Science - MS, Psychology