Manju Choudhary
Clinical Research Coordinator
Mumbai
Summary
Clinical Research Coordinator with 1.10 years of experience in Phase II–IV clinical trials. Skilled in patient recruitment, informed consent, regulatory submissions, and data documentation. Strong knowledge of ICH-GCP with hands-on monitoring support experience. Eager to leverage site coordination expertise to grow into a CRA/CTA role with a leading CRO or sponsor.
Overview
3
3
years of professional experience
2
2
Certifications
3
3
Languages
Work History
Clinical Research Coordinator
P.D Hinduja National Hospital & MRC
Mumbai
08.2024 - Current
- Coordinated Phase II–IV clinical trial activities, including site initiation, monitoring, and close-out visits as per protocol and ICH-GCP guidelines
- Handled patient screening, recruitment, and informed consent; managed visit scheduling and follow-ups to ensure protocol compliance
- Maintained accurate CRF/eCRF data , screening and enrollment logs, and ISF/TMF documentation
- Reported Serious Adverse Events (SAEs) to CDSCO and relevant authorities within required timelines
- Worked with the Principal Investigator and study team to resolve data queries and ensure data accuracy
- Supported Ethics Committee (IEC) submissions, approvals, and ongoing documentation
- Managed patient reimbursements, travel allowances, and related records as per site SOPs
- Coordinated study drug and lab sample collection, processing, and shipment as per protocol
- Supported monitoring visits, audits, and query resolution
- Assisted in site close-out activities and documentation
- Attended Investigator Meetings with the PI for study-related discussions
Clinical Research Intern
P.D Hinduja National Hospital & MRC
Mumbai
05.2023 - 03.2024
- Assisted in informed consent process and patient recruitment under Principal Investigator guidance.
- Maintained Investigator Site File (ISF), CRFs, and updated study-related documentation.
- Supported sponsor monitoring visits, site feasibility assessments, and audits/inspections.
- Recorded patient visits, medical history, and adverse events; contributed to SAE reporting on the SUGAM portal.
- Ensured accuracy in Electronic Data Capture (EDC) systems and resolved queries in coordination with CRA.
- Managed investigational product accountability including storage, dispensing, and temperature logs.
- Facilitated site readiness by organizing sponsor meetings and ensuring compliance with ICH-GCP and protocol requirements.
Education
Post Graduate Diploma - Clinical Research
ICRI Institute
Mumbai01-2024
M.Sc. - Botany
Mithibai College
Mumbai01-2023
Bachelor of Science - Botany
Mithibai College
Mumbai 04.2001 -
Skills
- Site Coordination & Trial Management
- Patient recruitment
- AE/SAE Reporting
- Ethics Submissions & Regulatory Docs
- Source Data & EDC Entry
Certification
ICH-GCP E6(R3) - Completed, 2025
Timeline
Clinical Research Coordinator
P.D Hinduja National Hospital & MRC
08.2024 - Current
Clinical Research Intern
P.D Hinduja National Hospital & MRC
05.2023 - 03.2024
Bachelor of Science - Botany
Mithibai College
04.2001 -
M.Sc. - Botany
Mithibai College
Post Graduate Diploma - Clinical Research
ICRI Institute