Resume - Dr. Ravikumar C. Kanani

Dr. Ravikumar C. Kanani

Phone: +1-551-***-****

Email: ad08yq@r.postjobfree.com

Address: *** ********* ******, ****** ****, NJ 07307 Objective:

I am actively seeking a position in the clinical trial field, where I can leverage my extensive experience spanning five years in clinical research as a Research Associate, encompassing phases 1 through 4. My major experience in the development of cost-effective drugs, vaccines, suspensions, and generic medicines aimed at benefiting humanity at large. My commitment to adhering to international guidelines and conventions has been a cornerstone of my career, enabling me to successfully navigate regulatory audits conducted by esteemed agencies such as the US FDA, the Ministry of Health in Malaysia, the MHRA in the UK, and the DCGI in India, thereby securing approvals for various clinical trial projects. I am particularly proud of my collaboration with top-ranked scientists in the USA and other countries, which culminated in a publication related to COVID-19 vaccine trials.

Education:

● Master in Health Informatics in New England College, NH, USA-2023

● MBBS (Doctor of Medicine), KSKVKU-Bhuj, GAIMS, Bhuj, India- 2016

● Health Research Fundamentals, Indian Council of Medical Research, National Institute of Immunology, 2022

Work Experience:

1. C-Trial Global Private Limited, Research Associate, Research and Development (R&D), May 2022 to August 2023

● Managing relationships with sites and ensuring their performance.

● Handling site initiation and patient recruitment strategies.

● Site quality and delivery from identification through close-out.

● Building strong Conducting feasibility and qualification activities.

● Managing regulatory documents and submissions.

● Addressing site issues and ensuring compliance.

● Providing training and support to sites.

● Ensuring data quality and integrity.

● Participating in audits and inspections.

● Monitoring site activities and ensuring compliance with regulations.

● Reviewing safety reports and ensuring timely reporting.

● I work independently, maintain compliance, and collaborate with team members to meet project goals, making sure assigned sites are audit-ready. My expertise spans clinical trial management and drug safety activities

2. Cadila Pharmaceuticals Limited, Dholka Ahmedabad, clinical research associates/coordinator, Research and Development (R&D) Assistant Manager (From 04 Resume - Dr. Ravikumar C. Kanani

June 2019), Contract-based: April 2018 to February 2019, Permanent: June 2019 to July 2022

● Conducted trials for diseases such as Covid-19, Rabies, and diabetes.

● Resolved queries from stakeholders including trial sites, IEC, sponsors, and project teams.

● Managed serious adverse events and ensured their appropriate assessment and causality determination.

● Reviewed lab reports, and subject profiles, and provided medical oversight during ongoing trials.

● Established relationships with alliance partners, external companies, investigators, and opinion leaders.

● Led site staff training and retraining on medical issues, safety recording, and reporting.

● Participated in protocol design, SOP development, and regulatory submissions.

● Supervised trial operations, IP handling, and pharmacy management. 3. DR. M. K. Shah Medical College and Research Centre, Ahmedabad Junior Resident/ research coordinator in Clinical Trial Centre September 2016 to April 2018

● Perform all trial site activity

● Planned and managed clinical trials under ICH GCP guidelines and regulatory requirements.

● Coordinated with sponsors, HREC, and regulatory agencies for trial approvals.

● Conducted site initiation meetings, patient screening, and trial-specific procedures.

● Performed clinical assessments, collected and recorded data, and monitored patient safety.

● Assisted in the preparation of clinical study reports and manuscripts. Skills:

● Clinical trial management

● Adverse event reporting

● Medical monitoring and Regulatory compliance

● Good Clinical Practice (GCP)

● Drug safety and pharmacovigilance

● Protocol design and development

● Data collection and analysis

● Scientific research

● Medical writing

● Strong interpersonal and communication skills

Certifications:

● Certified Clinical Research Professional (CCRP), Society of Clinical Research Associates (SOCRA), 2019

● ICH-GCP certification, Transcelerate Biopharma Inc., 2018 Publications:

● INNATE IMMUNE MODULATION AND RESISTANCE TO COVID-19, Ravikumar C. Kanani, Sivapriva J. Geetha, Sanjay Patel Bakulesh Khamar*, Alexander T. Honkala, Sanjay V. Malhotra https://www.ejbps.com/ejbps/abstract_id/7847

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