RUCHITA VAIDYA
Mumbai
Summary
Adaptable professional with expertise in clinical trial management and regulatory compliance.
Known for strong multitasking abilities and meticulous documentation skills, contributing to streamlined clinical processes and successful study outcomes.
Overview
1
1
year of professional experience
Work History
CLINICAL TRIAL ASSISTANT
Alkem Laboratories Ltd
Mumbai
03.2025 - Current
- Assisted Clinical Research Manager in startup activities, preparing project reports for stakeholders.
- Ensured the completion of project-specific training within timelines, updating records.
- Supported preparation for investigator meetings and CRA training, enhancing team readiness.
- Coordinated meetings between clinical teams and external stakeholders.
- Prepared submissions for Institutional Review Board or Ethics Committee approval, amendments, renewals.
- Tracked subject enrollment status, screening results, adverse events, concomitant medications.
- Coordinated shipment of study materials between sponsors, investigators, vendors.
- Assisted in the development of clinical trial protocols, case report forms, and other study document.
- Assisted in coordinating clinical trial documentation for regulatory submissions.
- Organized meetings and maintained communication with clinical trial stakeholders.
- Prepared study materials and ensured compliance with standard operating procedures.
CLINICAL RESEARCH COORDINATOR
SP Bioscience LLP
Mumbai
02.2025 - 03.2025
- Coordinated participant recruitment and enrollment for clinical trials.
- Assisted in preparing regulatory documents for study submissions.
- Monitored compliance with protocols during clinical research activities.
- Documented study data accurately in electronic data systems.
- Compiled trial related documents into a master file as required by sponsor or regulatory agency.
- Developed and maintained accurate and timely study databases.
- Assisted in the preparation of Institutional Review Board submissions for clinical trials.
- Organized training sessions for staff on study protocols and procedures. Monitored patient safety during clinical trials according to established guidelines.
- Monitored patient safety during clinical trials according to established guidelines.
Education
Advanced Diploma in Clinical Research -
Clinomic Clinical Research Institute
Mumbai09-2025
Master of Pharmacy: Pharmacology
St. John Institute of Pharmacy And Research
Palghar08-2024
Bachelor of Pharmacy: Pharmacy
Dr. Babasaheb Ambedkar Technological University
Aurangabad04-2022
Skills
- Clinical trial management
- Regulatory compliance
- Documentation management
- IRB and IEC submissions in Clinical operations
- Good clinical practice
- Multitasking capacity
Languages
English
Proficient (C2)
C2
Marathi
Native
Native
Hindi
Proficient (C2)
C2
Timeline
CLINICAL TRIAL ASSISTANT
Alkem Laboratories Ltd
03.2025 - Current
CLINICAL RESEARCH COORDINATOR
SP Bioscience LLP
02.2025 - 03.2025
Advanced Diploma in Clinical Research -
Clinomic Clinical Research Institute
Master of Pharmacy: Pharmacology
St. John Institute of Pharmacy And Research
Bachelor of Pharmacy: Pharmacy
Dr. Babasaheb Ambedkar Technological University