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Deeksha Topwal

@deekshatopwal

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Result-driven clinical research professional with 3+ years of experience.

India

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What I'm looking for

I am looking for a role that offers growth opportunities and a collaborative environment.

I am a result-driven professional with over 3 years of experience in clinical research operations and management. My expertise lies in overseeing clinical trials, ensuring compliance with regulatory guidelines, and managing trial-related documentation. I have successfully contributed to various projects in oncology and dermatology, demonstrating my ability to work collaboratively within multidisciplinary teams.

Throughout my career, I have honed my skills in data management, patient recruitment, and regulatory compliance. I am proficient in preparing project management plans and have a solid understanding of Good Clinical Practice (GCP) guidelines. My strong organizational and communication skills have enabled me to effectively liaise between sponsors and study sites, ensuring the integrity and accuracy of clinical data.

I am passionate about advancing clinical research and am committed to maintaining the highest ethical standards in my work. I continuously seek opportunities to enhance my knowledge and skills in the field, aiming to contribute to innovative research that improves patient outcomes.

Experience

Work history, roles, and key accomplishments

Current

Clinical Research Associate

Current

Clinical Research Network India

Nov 2024 - Present (7 months)

Oversaw clinical trials at study sites, ensuring adherence to protocol, good clinical practice (GCP), and regulatory guidelines. Conducted routine site visits to verify source data, resolve queries, and ensure compliance with regulatory requirements.

Clinical Trials GCP Regulatory Compliance Data Collection SAE Reporting Project Management

Clinical Trial Associate

Veeda Clinical Research Ltd.

Jan 2022 - Apr 2024 (2 years 3 months)

Updated and maintained clinical systems to track site compliance and performance within project timelines. Assisted in the planning and management of clinical trials, including recruitment, screening, and data management.

Project Management Clinical Trials Data Management Query Resolution SOPs Regulatory Compliance SAE Reporting Biznet Octalsoft

Clinical Trial Assistant (Start-up CTA)

Cliantha Research Pvt. Ltd.

Jan 2021 - Jul 2021 (6 months)

Initiated study start-up processes and coordinated with Principal Investigators and research sites. Responsible for the compilation and submission of EC dossiers and the collection and QC of essential documents.

Study Start Up EC Dossier Submission Site Master Files IMP Requests E Folders

Clinical Research Coordinator

Clinocare CR

Apr 2020 - Jan 2021 (9 months)

Managed patient pre-screening, recruitment, follow-up, and data entry into eCRF and EDC systems. Coordinated with the principal investigator to ensure clinical trial adherence to ICH-GCP and ICMR guidelines.

Patient Recruitment Data Entry EDC ICH GCP ICMR Guidelines EC Notifications IP Management

Internship CRC (Trainee)

Max Hospital

Oct 2019 - Mar 2020 (5 months)

Coordinated with the principal investigator to ensure clinical trial compliance with ICH-GCP and ICMR guidelines. Managed document submission for EC approval, notifications, and communications with the EC.

ICH GCP ICMR Guidelines EC Approval IP Management Data Tracking EC Notifications Clinical Trials

Education

Degrees, certifications, and relevant coursework

Swami Rama Himalayan University

M. Sc., Clinical Research

Completed a Master of Science in Clinical Research, gaining in-depth knowledge of clinical trial methodologies and regulatory guidelines. Focused on advanced research practices and data management in the clinical field.

Uttarakhand Technical University

B. Sc., Biotechnology

Obtained a Bachelor of Science in Biotechnology, focusing on the scientific principles and applications of biotechnology. Developed a strong foundation in biological sciences relevant to research and development.