Kishlaya Chaudhary
Varanasi
Summary
Dynamic Clinical Research Associate with proven expertise at OSSINC in developing clinical trial protocols and ensuring compliance with regulatory standards. Skilled in statistical analysis and adept at fostering collaboration among research teams. Recognized for enhancing data integrity and patient care documentation, driving successful study outcomes through effective communication and leadership.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Clinical Research Associate I
OSSINC
Lucknow
03.2022 - 05.2025
- Oversaw development of clinical trial protocols, collaborating on statistical analysis plans and regulatory submissions.
- Participated in identifying potential investigators and clinical sites through pre-study visits and evaluative reports.
- Assisted in selecting contract research organizations by assessing qualifications for proposed research activities.
- Developed and implemented study-specific monitoring procedures, establishing baseline parameters and tracking systems.
- Conducted site initiation visits, training personnel on sponsor and regulatory requirements for study conduct.
- Performed site monitoring visits to ensure compliance with state and federal regulations, addressing significant issues.
- Reviewed clinical files for accuracy and compliance, providing remedial training and initiating corrective actions as necessary.
- Facilitated termination of clinical studies by conducting site visits, reviewing documentation, and preparing termination reports.
CTA & Junior Clinical Research Associate
OSSINC
Lucknow
03.2022 - 03.2022
- Supervised study sites and activities to ensure compliance with industry protocols and study terms.
- Collected and authenticated case report forms for data integrity.
- Screened potential participants through medical record reviews, interviews, and healthcare provider follow-ups.
- Coordinated with ethics committees to protect rights and safety of research subjects.
- Maintained comprehensive records of research activities, including regulatory forms and consent documents.
- Prepared final reports, manuscripts, New Drug Applications (NDAs), and Biological License Applications (BLAs).
- Ensured accurate transmission of clinical case data to management centers and addressed report discrepancies.
- Oversaw research staff, focusing on training, hiring, goal setting, and workload distribution.
Trainee to Senior Clinical Research Coordinator
OSSINC
Lucknow
03.2020 - 03.2022
- Participated in preparation and management of research budgets and financial payments.
- Notified subjects about all relevant study aspects.
- Entered study data into the applicable database for accurate record-keeping.
- Monitored study activities to ensure compliance with local, state, and national regulations.
- Managed records of study-related activities including case report forms and drug dispensation.
- Communicated laboratory findings to researchers for informed decision-making.
- Enrolled subjects according to study protocol requirements.
- Prepared for quality assurance audits conducted by sponsors and regulatory authorities.
Intern Clinical Pharmacist
Max Multispeciality Hospital
Dehradun
07.2019 - 08.2019
- Assessed patient conditions to determine appropriate medication therapies.
- Determined dosages and frequencies based on detailed patient data.
- Explained treatment regimens to patients, emphasizing safe administration.
- Evaluated patients and collaborated with physicians to identify risk factors.
- Documented treatments and tracked patient progress meticulously.
- Ensured consistent delivery of high-quality patient care.
- Reviewed clinical trials to evaluate drug efficacy and potential side effects.
- Implemented safety measures for compliant medication storage.
Education
M.Sc. - Clinical Research
Institution of Clinical Research India (ICRI)
Dehradun, UK, India07.2020
B.Sc. - Biotechnology
Mahatma Gandhi Kashi Vidyapeeth
Varanasi, Uttar Pradesh, India04.2018
12th Board -
Happy Model School
Varanasi, Uttar Pradesh, India04.2015
10th High School -
SantAtulanand Residential Academy
Varanasi, Uttar Pradesh, India05.2013
Skills
- Clinical trial methodology and principles
- Research monitoring plans
- Statistical analysis techniques
- Laboratory certification standards
- Adverse event investigation
- Contract research organization operations
- Technical report development
- Clinical trials trends and standards
- Good clinical practices
- Patient care documentation
- Oral and written presentations
- Data management guidelines
- Technical support and guidance
Certification
- Good Clinical Practices by NIDA (National Institute of Drug Abuse)
- Good documentation practices (GDP)
- Good Monitoring reporting documentation
Disclaimer
I hereby declare that all the information given above is true to the best of my knowledge
Timeline
Clinical Research Associate I
OSSINC
03.2022 - 05.2025
CTA & Junior Clinical Research Associate
OSSINC
03.2022 - 03.2022
Trainee to Senior Clinical Research Coordinator
OSSINC
03.2020 - 03.2022
Intern Clinical Pharmacist
Max Multispeciality Hospital
07.2019 - 08.2019
M.Sc. - Clinical Research
Institution of Clinical Research India (ICRI)
B.Sc. - Biotechnology
Mahatma Gandhi Kashi Vidyapeeth
12th Board -
Happy Model School
10th High School -
SantAtulanand Residential Academy
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