Open to opportunities

Ashesh Agrawal

@asheshagrawal

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Experienced Senior Clinical Research Associate with expertise in managing clinical trials across div

United States

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What I'm looking for

Seeking a challenging role that leverages my expertise in clinical trial management, offering opportunities for professional growth and involvement in diverse therapeutic areas.

I am a dedicated Senior Clinical Research Associate with 14 years of experience in clinical trials, having worked with over 50 sponsors across various therapeutic areas. My expertise includes managing all phases of clinical trials, from initiation to close-out, ensuring compliance with ICH-GCP guidelines and regulatory requirements.

In my current role at ICON, I monitor clinical trials, conduct site visits, and ensure data accuracy. I've successfully reduced CRA queries by 95% through rigorous QA processes and effective staff training. My experience spans multiple therapeutic areas, including cardiovascular, endocrinology, and infectious diseases.

I am passionate about maintaining high standards of quality and efficiency in clinical research. My achievements include leading high-performing sites and consistently meeting recruitment targets. I am committed to continuous learning and staying updated on industry developments to contribute effectively to clinical research advancements.

Experience

Work history, roles, and key accomplishments

Current

Sr. Clinical Research Associate

Current

ICON

Jan 2023 - Present (2 years 5 months)

As a Sr. Clinical Research Associate at ICON, I identify, select, initiate, and close-out investigational sites for clinical studies. I ensure compliance with study protocols and regulations, assist in staff training, and manage regulatory documents for study site activation.

Clinical Research ICH GCP Regulatory Compliance Staff Training Monitoring SOP Development Quality Assurance

CRA II

Syneos Health

Sep 2022 - Jan 2023 (4 months)

In my role as CRA II at Syneos Health, I monitored clinical trials to ensure adherence to Good Clinical Practice and compliance with study procedures. I managed site performance and documentation across multiple sites.

Monitoring Clinical Trials Site Performance Documentation Regulatory Compliance Quality Assurance

CRA I

ICON

Aug 2021 - Sep 2022 (1 year 1 month)

As a CRA I at ICON, I monitored clinical trials, ensuring compliance with regulatory requirements and ICH-GCP guidelines. I assessed site qualifications and managed trial documentation.

Monitoring Clinical Trials ICH GCP Documentation Management Regulatory Compliance

CRA I

IQVIA

Feb 2021 - Aug 2021 (6 months)

In my position as CRA I at IQVIA, I performed site selection, initiation, monitoring, and closeout visits, ensuring compliance with protocols and regulations while managing site communications.

Site Selection Management Compliance Quality Assurance Documentation

Site Director

Neurology Diagnostics, Inc

Dec 2018 - Feb 2021 (2 years 2 months)

As Site Director, I ensured efficient trial conduct in compliance with FDA and ICH-GCP guidelines. I managed logistics, regulatory submissions, and quality assurance activities for multiple trials.

FDA Compliance ICH GCP Regulatory Submissions Quality Assurance

Clinical Research Coordinator

Clinical Inquest Center, Ltd

Feb 2011 - Dec 2018 (7 years 10 months)

As a Clinical Research Coordinator, I managed the execution of clinical trials, ensuring compliance with FDA and ICH-GCP guidelines. I coordinated logistics, regulatory submissions, and staff training.

FDA Compliance ICH GCP Regulatory Submissions Staff Training Quality Assurance