Kirtiraj Deewan
Clinical Research Professional
Leicester,Leicestershire
Summary
Senior Research Associate specializes in establishing project objectives, developing experimental plan and effectively prioritizing tasks to meet time sensitive delivery goals. Knowledgeable about action planning, protocol compliance, database locking and standard operating procedures. Supports participant recruitment and management to meet research objectives. Excellent attention to detail with organizational and prioritization skills for efficient productivity.
Overview
7
7
years of professional experience
Work History
Senior Clinical Research Associate
Cadila Pharmaceuticals
12.2022 - 12.2023
- Conducted independent research to validate efficacy of solutions, assimilate results and prepare written technical reports.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Managed project risk by identifying, quantifying and monitoring potential threats.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Monitored patient safety throughout clinical trials and reported any adverse events.
Sr. Research Scientist
Veeda Clinical Research
03.2017 - 03.2022
- Review the protocol, Inform Consent Documents (English and/or vernacular language), Case Report Form (CRF) and/or associate working documents related to study.
- Review the Trial Master File before the Commencement of study.
- Review all the study related documents(CRF and source documents) to ensure the completeness, correctness and compliance to the protocol, SOP & applicable regulatory guidelines.
- Ensure the necessary actions are taken for the rectification and all the findings/comments/suggestions are resolved.
- Verify the performance check for all the clinical emergency equipments & Panic buttons (but not in limit to) before commencement of the clinical studies.
- Monitor all the following study specific activities (but not in limited to) to ensure compliance to the protocol and the governing SOPs.
Education
Certificate Course of Management - Hospitality Administration And Management
Boston Business Management School
Singapore 04.2001 -
Bachelor of Science - Human Nutrition
Maharana Shahujipratap University
Kanpur 04.2001 -
Skills
Site Management
Good Clinical Practices
Trial Management
Medication Dispensing
Informed Consent
Study Protocols
Qualification/Initiation/Monitoring/closeout of clinical trial sites
Source data verification
Investigation product accountability
Clinical data Management
Trial Master File
Standard Operation Procedure
Timeline
Senior Clinical Research Associate
Cadila Pharmaceuticals
12.2022 - 12.2023
Sr. Research Scientist
Veeda Clinical Research
03.2017 - 03.2022
Certificate Course of Management - Hospitality Administration And Management
Boston Business Management School
04.2001 -
Bachelor of Science - Human Nutrition
Maharana Shahujipratap University
04.2001 -
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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