Months Of professional experience
Akash Godiwal
Clinical Research Professional
Delhi
Summary
Clinical research professional with hands-on experience in clinical trial coordination, TMF/eTMF management, and GCP-compliant processes. Skilled in site communication, documentation management, and supporting study start-up and monitoring activities. Experienced across sponsor and site settings, with exposure to RCTs and cohort studies. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
3
3
Work History
Trainee CTA
PFC Pharma Focus India Pvt. Ltd.
Gurugram
01.2026 - Current
- Supporting clinical trial operations and coordination activities across multiple study sites.
- Assisting in the collection, review, and filing of essential documents (ISF and TMF).
- Coordinating with site teams for study-related documentation and follow-ups.
- Assisting in patient dealings and site coordination as a backup CRC.
- Tracking site activities, visit reports, and study timelines.
- Assisting the manager in preparing the EC dossier and regulatory dossier.
- Ensuring document completeness and audit readiness.
Intern
sun pharmaceutical industries Ltd.
Gurugram
05.2025 - 11.2025
- Supported TMF/eTMF (IQVIA and Navitas eTMF) documentation, ensuring compliance with GCP and SOPs.
- Assisted in feasibility assessment and site selection activities.
- Contributed to clinical data management processes, including query handling basics.
- Supported cross-functional coordination and regulatory workflows.
- Gained exposure to safety reporting and protocol compliance.
Internship Trainee
Employees' State Insurance Corporation Medical College and Hospital
Faridabad
09.2024 - 09.2024
- Assisted in participant screening and enrollment in a pneumococcal vaccine trial.
- Supported the informed consent process and documentation.
- Ensured adherence to protocol and study procedures.
Internship Trainee
Gurugram Civil Hospital
Gurugram
09.2024 - 09.2024
- Assisted in prescreening, screening, and enrollment of study participants.
- Supported longitudinal follow-up and data collection processes.
- Maintained accurate documentation, and ensured data quality.
Internship Trainee
Vardhman Mahavir Medical College & Safdarjung hospital
New Delhi
09.2024 - 09.2024
- Supported screening, enrollment, and drug-dispensing activities of the WHO ACTION-III trial (Antenatal Corticosteroids for Improving Outcomes in preterm Newborns).
- Assisted in the informed consent process and participant follow-up.
- Gained exposure to multi-country double-blind RCT operations.
Apprenticeship
Institute of Nuclear Medicine & Allied Sciences (INMAS-DRDO)
New Delhi
04.2023 - 09.2023
- Assisted in artificial cornea development research
- Performed RT-PCR, electrophoresis, and nucleic acid extraction
- Maintained lab documentation and ensured QC practices
Internship Trainee
Vardhman Mahavir Medical College & Safdarjung hospital
New Delhi
11.2019 - 08.2022
- Working as an intern trainee in different labs at Safdarjung Hospital.
- Assisted lab teams across Microbiology, Biochemistry, Pathology, and Blood Bank departments in processing and analyzing blood samples.
- Performed phlebotomy, specimen collection, and media preparation, following standard protocols.
- Supported daily lab operations through accurate record-keeping and sample preparation for diagnostic testing.
Education
Master of Science - Clinical Research
Translational Health Science And Technology Institute, Regional Centre of Biotechnology
Faridabad, Haryana, India 04.2001 - 10.2025
B.Sc. MLT - Health Education
Vardhman Mahavir Medical College & Safdarjung Hospital
New DelhiXII -
Kalka Public School
New DelhiSkills
Clinical Trial Assistant (CTA) activities and site coordination
Good understanding of site monitoring visits (SIV, monitoring, close-out)
Knowledge of ICH-GCP and Declaration of Helsinki
Site communication and coordination
Coordinated in participant recruitment and enrollment tracking
Good understanding of protocol compliance and study procedures
TMF and eTMF management and document tracking
Support in regulatory document collection and submission
Good knowledge of CRF review and data query handling
Data quality check and adherence to protocol
Monitoring visit preparation and follow-up support
Study progress tracking (enrollment, documentation, timelines)
Preparation of study-related documentation and reports
Basic understanding of audit readiness and inspection processes
Good knowledge of SAE Reporting
Proficient in Microsoft and Google Word, Excel, and PowerPoint
Timeline
Trainee CTA
PFC Pharma Focus India Pvt. Ltd.
01.2026 - Current
Intern
sun pharmaceutical industries Ltd.
05.2025 - 11.2025
Internship Trainee
Employees' State Insurance Corporation Medical College and Hospital
09.2024 - 09.2024
Internship Trainee
Gurugram Civil Hospital
09.2024 - 09.2024
Internship Trainee
Vardhman Mahavir Medical College & Safdarjung hospital
09.2024 - 09.2024
Apprenticeship
Institute of Nuclear Medicine & Allied Sciences (INMAS-DRDO)
04.2023 - 09.2023
Internship Trainee
Vardhman Mahavir Medical College & Safdarjung hospital
11.2019 - 08.2022
Master of Science - Clinical Research
Translational Health Science And Technology Institute, Regional Centre of Biotechnology
04.2001 - 10.2025
XII -
Kalka Public School
B.Sc. MLT - Health Education
Vardhman Mahavir Medical College & Safdarjung Hospital
Publication
- From Spores to Suffering: Understanding the Role of Anthrax in Bioterrorism — Military Medicine, AMSUS (Oxford Academic)