ANUSHKA HEMANT BHADRA
Summary
Experienced healthcare practitioner with over 5 years of expertise in supporting patients. Skilled in transporting, ambulating patients, and maintaining accurate chart updates. Known for ensuring clients adhere to regulatory standards and achieve compliance. Proficient in consulting, reporting, and implementing process improvements to enhance patient care services.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Biomed
09.2024 - 12.2024
- In order to ensure compliance with the FDA – 21 CFR Part 11, Part 50, Part 56, ICH–GCP, and HIPAA, supported Phase 2 clinical trials for the Tandem Insulin medical device.
- In order to ensure compliance with 21 CFR Part 312 and expedite submission times, the clinical, data management, and regulatory teams collaborated.
- Supported risk reduction and data review in accordance with ICH E2A pharmacovigilance requirements, guaranteeing patient safety and trial integrity.
- Accelerated regulatory approvals, improved audit preparedness in accordance with ICH E6–R2, and created and maintained trial materials (informed consent forms, protocols).
Quality Intern
Biomed
01.2024 - 09.2024
- Company Overview: Quality Intern
- Received, sampled, inspected, tested, and released more than 15 batches per month of incoming raw materials, reagents, and components in compliance with SOPs, ensuring timely production support.
- Oversaw the timely reporting of data and compliance with regulatory standards for over ten external laboratories' outsourced analytical, microbiological, and biochemical testing.
- Supervised more than fifty logbooks, kept all equipment in calibration in accordance with ISO 17025 standards, and kept laboratories safe, 100% cGMP-compliant, and inspection-ready.
- Quality Intern
Pateint Care Technician
Ipca Laboratories
01.2022 - 12.2022
- Assisted with feeding and monitored intake to help patients achieve nutritional objectives.
- Assisted in transferring patients, beds and patient care equipment to other rooms adhering to necessary safety precautions.
- Maintained clean and safe environment to promote patient safety and comfort.
- Documented patient information and care activities in electronic health record.
- Completed activities of daily living for patients unable to self-care, and assisted those with limited mobility in completing tasks.
- Responded to patient requests for supplies and personal comfort items such as extra blankets.
- Assisted nursing staff with completing daily rounds, documenting vital signs and answering calls.
Regulatory Intern
Ipca Laboratories
01.2022 - 12.2022
- Company Overview: India
- Over ten Deviations and Change Control situations were examined and evaluated, taking into account important regulatory criteria including the ICH, Variation criteria, US Guidelines, and Asean Guidelines.
- Successfully updated the Registration Status for multiple African and CIS nations, involving more than 12 drugs and biologics, enhancing comprehension of validity and renewal processes.
- Examined a variety of inquiries from Ministries of Health (MOHs) in 15 different nations, obtaining thorough knowledge of the ten essential precautions and care that must be taken in order to respond effectively.
- India
- Analyzed problems and worked with teams to develop solutions.
- Sorted and organized files, spreadsheets, and reports.
Education
Master of Science - Regulatory Affairs
Northeastern University
Boston, MA12-2024
Bachelor of Science - Pharmacy
Dr Bhanuben Nanavati College of Pharmacy
Mumbai05-2022
High School Diploma -
Pushpakant Mhatre College of Science
Mumbai05-2018
Skills
- Argus
- CIS
- FDA
- GCP
- HIPAA
- QMS
- Six Sigma
- CAD
- Gmail
- Microsoft
- Risk Management
- Veeva Vault
- Study protocols
- Patient hygiene management
- Restocking supplies
- Vital signs monitoring
- ADL support
- Infection prevention
Accomplishments
- Successfully expedited 15% faster regulatory submissions for clinical trials in collaboration with teams.
- Reviewed and optimized 36 SOPs, reducing procedural errors by 20% across new sites.
- Achieved 100% cGMP compliance while managing calibration of over 50 logbooks.
- Contributed to IND submissions, resulting in a 25% faster approval rate from FDA.
- Used Microsoft Excel to develop inventory tracking spreadsheets.
- Resolved product issue through consumer testing.
Certification
- PT - Phlebotomy Technician
- MLT - Medical Laboratory Technician
Timeline
Clinical Research Coordinator
Biomed
09.2024 - 12.2024
Quality Intern
Biomed
01.2024 - 09.2024
Pateint Care Technician
Ipca Laboratories
01.2022 - 12.2022
Regulatory Intern
Ipca Laboratories
01.2022 - 12.2022
Master of Science - Regulatory Affairs
Northeastern University
Bachelor of Science - Pharmacy
Dr Bhanuben Nanavati College of Pharmacy
High School Diploma -
Pushpakant Mhatre College of Science
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