Dr. Rahul Thakor
Ahmedabad
Summary
Detail-oriented and highly skilled Clinical Research Professional with over two years of experience in performing and monitoring site management work to ensure that sites are conducting studies and reporting clinical trial study data as per the protocol, applicable regulations and guidelines, and sponsor requirements. Proficient in ICH-GCP guidelines, site, and vendor management, & maintaining critical trial documentation. Adept at ensuring compliance, resolving queries, and maintaining efficient communication with cross-functional teams. Recognized for exceptional time management, mentorship capabilities, and a commitment to quality and accuracy in clinical research processes.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Clinical Research Associate
CBCC Global Research LLP
Ahmedabad
09.2024 - Current
- Act as the primary point of contact for assigned clinical sites to oversee trial conduct from site initiation through close-out.
- Conduct Qualification, Initiation, Monitoring, and Close-Out Visits both onsite and remotely, generating comprehensive visit reports.
- Prepare, negotiate, and facilitate execution of CDAs and Clinical Site Agreements (CSAs) including amendments.
- Customize, review, and negotiate Informed Consent Forms (ICFs) per regulatory/client specifications.
- Submit regulatory packages to IRB/IEC and MoH/RA, manage approval timelines, and resolve regulatory conflicts efficiently.
- Collect, review, and approve essential regulatory documentation (SRP), ensuring compliance with trial requirements.
- Oversee study systems access and ensure site staff complete project-specific training prior to study start.
- Monitor site performance, data quality, patient safety, and protocol compliance using CTMS, EDC, and TMF systems.
- Develop and implement patient recruitment and retention strategies in collaboration with site teams.
- Resolve site issues, including training gaps, recruitment hurdles, and data entry delays; escalate when necessary.
- Ensure timely follow-up on CRFs, SAE reports, site payments, investigational product (IP) accountability, and protocol deviations.
- Maintain audit-readiness and contribute to inspection readiness.
Jr. Clinical Research Associate
CBCC Global Research LLP
Ahmedabad
08.2022 - 08.2024
- Conducted feasibility assessments and tracked site selection progress.
- Coordinated EC submission processes, prepared EC and SIV dossiers, and tracked EC opinion validity.
- Supported recruitment forecasting and mitigation plans across oncology studies.
- Managed TMF and QMS documentation and performed archival at study completion.
- Tracked and facilitated IP & PK sample shipments; forecasted IP supply needs.
- Created finance projections, tracked invoices and POs; supported contract and budget execution.
- Created meeting MoMs, tracked action items, and collaborated with cross-functional teams.
- Mentored and junior CRAs and participated in system audit readiness.
Education
Doctor of Pharmacy (Pharm D) -
Parul University
Vadodara05.2022
Skills
- Good Clinical Practices (GCP)
- Data review and Analysis
- SAE/AE Tracking & Query Resolution
- Patient Recruitment & Retention Strategy
- Site Monitoring
- Vendor Management
- eTMF
- IEC Submission
- Good Documentation Practices
- CTMS
- Effective site communication
- Electronic Data Capture (EDC)
- Collaboration and Rapport Building
- Microsoft Office
Awards
Employee of Quarter for July-September 2023
Experience In Clinical Studies
- Oncology: Head and Neck Cancer, Ovarian Cancer, Breast Cancer, Pancreatic Cancer, and Prostate Cancer
- Psychiatric: Schizophrenia
Certification
- Lean Six Sigma Yellow Belt
References
References available upon request.
Timeline
Clinical Research Associate
CBCC Global Research LLP
09.2024 - Current
Jr. Clinical Research Associate
CBCC Global Research LLP
08.2022 - 08.2024
Doctor of Pharmacy (Pharm D) -
Parul University
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