Medidta Rave
Nagaraju Vanguri
Clinical Reasearch Associate
Hyderabad
Summary
Accomplished Clinical Research Associate with 5 years of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards.
Overview
5
5
years of professional experience
15
15
years of post-secondary education
1
1
Certificate
4
4
Languages
Work History
Clinical Research Associate
Ardent Clinical Research Services
Hyderabad
05.2022 - Current
- Knowledge of clinical trial protocols, work in accordance with ICH Good Clinical Practices, New Drugs and Clinical Trials Rules 2019 and Standard Operating Procedures and Regulatory guidelines
- Handling “E-Systems” of clinical trials like e CRF, eTMF, and IWRS
- Identifying new potential Investigator Sites and develop sites to conduct clinical studies
- Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials
- Participate in preparation and coordination of investigator meetings or other investigator site training Perform site selection, initiation, routine monitoring visits and site close out visit activities
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans
- Developing, implementing and maintaining study documents, timelines, files, communication tools, and systems used in conducting project
- Review of informed consent form, consent procedure, source documents, case report form, protocol, investigator brochure & site master file
- Coordinate all lab related activities between Local/Central Laboratory and Courier for shipment of
- Samples
- Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues
- Conducted clinical trial in accordance with protocol and recorded and monitored progress
- Submitted routine monitoring reports and follow-up letters to facilitate internal and external communication
- Mentored team members by sharing suggestions and encouraging ideas to deliver successful studies
- Liaised with clinical project leader to effectively resolve study-related issues
- Oversaw project developments to provide quality deliverables while maintaining optimal efficiency.
Clinical Research Executive
QPS Holdings, LLC
Hyderabad
03.2020 - 08.2021
- Updating and maintaining Investigator Site File and sending progress reports to CRO
- EC related study documents submissions and notifying all Adverse events and Serious adverse events and other applicable regulatory requirements within timelines
- Immediately report any serious adverse events (SAEs) to PI and to sponsor, IRB, and regulatory authority
- Coordinate all lab related activities between Local/Central Laboratory and Courier for shipment of Samples
- Ensure trial is conducted in accordance with Good Clinical Practices, ICH GCP Guidelines, New Drug and Clinical Trial Rules and Standard Operating Procedures and Regulatory guidelines, and strong commitment to quality patient care
- Handling “E-Systems” of clinical trials like e CRF, eTMF
Research Associate
RA Chem Pharma Ltd
06.2017 - 02.2020
- Coordinate with study monitor during site selection, initiation, routine monitoring visits and site close out visit activities
- Developing, implementing and maintaining study documents, timelines, files, communication tools, and systems used in conducting project
- Maintaining study related Logs and Forms: Screening, Enrolment, Drug Accountability, Temperature and other communication logs
- Follow up with study team for timely completion of source documents and ensuring that all relevant information required in CRF are present in source document
- Assist investigating team in process of informed consent to subjects and explain in details about patient information sheet & patient diaries
- Coordinate Screening and recruitment of patients based on protocol eligibility criteria
- Expertise in handling “E-Systems” of clinical trials like e CRF and IWRS
- Perform data entry into EDC within timelines specified by sponsor (within 48 hours of subject follow up visit)
- Resolve Data Clarification Forms in consultation with investigator
- Maintaining Temperature of Investigational Product as per Protocol
- Performing Study Drug Accountability for each subject
- Updating and maintaining Investigator Site File and sending progress reports to CRO
- EC related study documents submissions and notifying all Adverse events and Serious adverse events other applicable regulatory requirements within timelines.
Education
Post Graduate Diploma - clinical research, Clinical Laboratory Science
Institute of Clinical Research
Bengaluru, KA 07.2015 - 12.2015
Bachelor of Pharmacy - Pharmacy Administration and Pharmacy Policy
SLCS Institute of Engineering And Technology
Hyderabad, TG 03.2010 - 07.2015
High School Diploma -
Triveni Junior College
Suriapet, TG 05.2008 - 03.2010
Secondary -
Sri Ramakrishna Vidhyamandhir
Suriapet, TG 01.2001 - 03.2008
Skills
Project Managementundefined
Certification
Good Clinical Practice (GCP)
Software
Source transcript
IWRS or IXRS
Veeva Valut
Timeline
Clinical Research Associate
Ardent Clinical Research Services
05.2022 - Current
Clinical Research Executive
QPS Holdings, LLC
03.2020 - 08.2021
Research Associate
RA Chem Pharma Ltd
06.2017 - 02.2020
Post Graduate Diploma - clinical research, Clinical Laboratory Science
Institute of Clinical Research
07.2015 - 12.2015
Bachelor of Pharmacy - Pharmacy Administration and Pharmacy Policy
SLCS Institute of Engineering And Technology
03.2010 - 07.2015
High School Diploma -
Triveni Junior College
05.2008 - 03.2010
Secondary -
Sri Ramakrishna Vidhyamandhir
01.2001 - 03.2008
Good Clinical Practice (GCP)
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