Anubhuti Gaur
Jodhpur
Summary
Knowledgeable Clinical Research Associate experienced in onsite and remote monitoring. Action-oriented with a strong ability to communicate effectively (both written and oral) with all stakeholders as demonstrated by serving as a liaison between sites and sponsor. Ensures trial sites are compliant with protocol requirements and the data captured is accurate by performing case report form review, query generation and resolution. Efficient in maintaining patient safety, regulatory compliance, and data integrity.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Clinical Research Associate
National Cancer Grid CRO, TATA Memorial Hospital
06.2023 - 01.2024
- Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
- Report writing, finalization and follow up
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
- Provide monitoring visits and site management for a variety of protocols, sites for Oncology studies
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Build awareness of features and opportunities of study to site.
- Communication with the site and sponsor for smooth regulation of the trial.
- Adverse event and Serious Adverse Event identification review and follow up.
Clinical Research Associate
Qrec Clinical Research Llp CRO
03.2022 - 04.2023
- Site identification, feasibility and Pre Site Selection Visit.
- Remote and Onsite monitoring visit for source data
verification and eCRF for accuracy and completeness. - Performed Case Report review, query generation and resolution against established protocol.
- Served as contact for project team and investigative sites
- Write visit reports and file and collate trial documentation and reports
- Regulatory submission (EC and CTRI)
- Assistance in Weblink preparation for Electronic Data capture
- Query management
- Site professional training for smooth initiation and regulation of study
- Vendor identification and payments
- Coordinated with medical writers for Analysis and Manuscript preparation.
Clinical Research Coordinator
Telesto Innovations SMO
06.2021 - 01.2022
- Assistance in patient screening and Informed Consent Process.
- Case Report Form completeness and Updating.
- Drug and study material handling.
- Assisted in Monitoring at the site.
- Communication withe the CRO team.
- Study related documents filling in the site Management fille.
Quality Control Assistant
Saras Dairy
02.2019 - 02.2020
- Performed biochemistry test on milk to check adulteration.
- Approved the milk and milk product before dispatching them in market and check the standby milk and milk product in the facilities as per the norms.
- Examine the fat in the milk and performed microbiological test.
Project Assistant Intern
CSIR- CFTRI
01.2017 - 05.2017
- Performed DNA Isolation, Amplification.
- Gene modification (Recombinant vector Preparation and amplification by PCR)
- Electrophoresis, SDS page technique , gene expression and western blotting for successful gene cloning and expression of (MGAM gene for Diabetes mellitus type 2)
Education
PG Diploma - Clinical Research And Pharmacovigilance
Frmetro Institute
Chennai, India12.2018
Master of Science - Biotechnology
Lachoo Memorial College of Science And Technology
Jodhpur, India06.2017
Skills
- ICH/GCP
- Onsite Monitoring
- Remote Monitoring
- EDC
- IVRS/IXRS
- CTMS
- Microsoft handling
- Drug Accountability
- Essential Documents
- Source Data Verification
- Source Data Review
- Remote Data Review
- Communication
- Regulatory knowledge
- Query management
Certification
- NIDA for GCP-ICH training
- Excel Fundamentals for Data Analysis: Coursera
- ICH GCP (The Global Health Network)
- Clinical Research Methodology
Timeline
Clinical Research Associate
National Cancer Grid CRO, TATA Memorial Hospital
06.2023 - 01.2024
Clinical Research Associate
Qrec Clinical Research Llp CRO
03.2022 - 04.2023
Clinical Research Coordinator
Telesto Innovations SMO
06.2021 - 01.2022
Quality Control Assistant
Saras Dairy
02.2019 - 02.2020
Project Assistant Intern
CSIR- CFTRI
01.2017 - 05.2017
PG Diploma - Clinical Research And Pharmacovigilance
Frmetro Institute
Master of Science - Biotechnology
Lachoo Memorial College of Science And Technology
- NIDA for GCP-ICH training
- Excel Fundamentals for Data Analysis: Coursera
- ICH GCP (The Global Health Network)
- Clinical Research Methodology
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