Teresa Rodriguez

Title

Senior CRA

Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines,

applicable regulations, SOPs and study processes. Activities include qualifying potential investigative

sites, initiating clinical trials, maintaining study files, providing instructions to site personnel and study close out.

Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to applicable regulations.

Ensures the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations and SOPs.

Manages the investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data deliverables.

Verifies proper management and accountability of Investigational Product (IP).

Writes and submits reports of investigational site findings and updates applicable tracking systems. Escalates observed deficiencies, issues, and corrective action

Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs and study processes. Activities include qualifying potential investigative

sites, initiating clinical trials, maintaining study files, providing instructions to site personnel and study close out.

Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to applicable regulations.

Ensures the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations and SOPs.

Manages the investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data

deliverables.

Verifies proper management and accountability of Investigational Product (IP).

Writes and submits reports of investigational site findings and updates applicable tracking systems. Escalates observed deficiencies, issues, and corrective action

a Senior Clinical Research Associate, I performed trial -related activities in compliance with the standard operating procedures, FDA regulations, ICH/GCP, Applicable local laws and regulations.

Source document review to ensure quality data.

Review Regulatory binder to ensure compliance with the clinical trial protocol.

Meet one on one with the investigator to ensure the PI is actively overseeing the conduct of the clinical trial.

Completed the PSV, SIV, IMV and COV as well as QA internal audits.

Provided a detailed report describing the site visit and ensuring all action items are listed on that report to ensure PM is aware of the action items and that these items get closed within the allowed time frame. Responsible for working independently by booking travel and completing expense reports.