Medical Assistant

SUMMARY

Enthusiastic, fast-learning, adaptive and experienced professional in Healthcare

Working knowledge of 21 CFR FDA, ICH, DHHS, TMF and guidance documents relating to Drugs, Biologics and Medical Devices

Understanding of IND, NDA, BLA, 510 (k) and PMA submissions in (e)CTD format

Experience in working with Informed Consent Forms (ICFs), Protocols, Reports, SOPs and Case Report Forms (CRFs)

5+ years of experience in research within the academia

Experience of recruiting study subjects in clinical trials

Proven track record of being professional, punctual and organized with applicable management skills

EDUCATION

Northeastern University, Boston Jul 2015 – Present

Master of Science (MS) in Regulatory Affairs in Drugs, Biologics, and Medical Devices GPA 4.0

Gained the essential knowledge and skills required to help companies navigate an increasingly complex regulatory environment. Acquired the foundation necessary to work within a variety of fields, including medical product development, pharmaceutical sales, strategic marketing, and clinical investigations.

Examined every step of the drug development and regulation process.

Analyzed the laws governing the development, manufacturing, and commercial distribution of drugs, biologics, and medical devices.

Sound knowledge of GMP/GLP environments.

Active knowledge of Insight, Agile, TMF, ICF, IRB approval, regulatory documentation and management of clinical trials.

Analyzed how emerging developments and trends are reshaping medical device regulations.

The University of Manchester, Manchester, U.K. Oct 2009 – Jan 2012

Master of Philosophy (MPhil) in Community Based Medicine and Toxicology GPA4.0

Research - “Quantitative analysis of the harmful effects of air pollution on DNA repair in vitro, in vivo and in acellular systems”.

University of Central Lancashire, Preston, U.K. Sep 2006 – Sep 2009 Bachelor of Science (BSc. Honours) in Molecular Biology and Biochemistry GPA 4.0 Research - “The physiological effects of diabetes mellitus on the skeletal and smooth muscle structure and functions in mice”.

CERTIFICATES

Making Biologic Medicines for Patients: The Principles of Biopharmaceutical Manufacturing from MIT

Care of Medicines Foundation Module from Boots Pharmacy

Medication Administration and Legislation/Policy from Boots Pharmacy

Safeguarding Vulnerable Adults and Children from Creative Support Ltd

Animal Handling according to the Scientific Procedures Act, 1986 from the University of Manchester

Radiation Safety Awareness from the University of Manchester

SKILLS

Gel electrophoresis of DNA and RNA (SDS PAGE)

PCR including Real Time PCR and Reverse Transcriptase PCR

ELISA, Northern and Western Blots using non-radioactive Probes

Dissection of mammalian embryos for cell line development

Animal manipulation, handling, feeding, breeding, marking and genotyping of transgenic animals

Bioinformatics tools and services like NCBI, Swiss PDB, EMBL, BLAST, and CLUSTALW

Titrations, spectrophotometry (Spec 21, UV-vis, Mass), chromatography (thin layer) and HPLC

Sterile technique in isolation and transfer of microorganisms

Basic operation and maintenance of microscopes

Molecular cloning using bacteria and plasmids

Proficiency in Microsoft Office, Word, Excel, PowerPoint, Project and Adobe

Ability to statistically analyze data

Technical writing, Literature search, Data entry, Document tracking

EMPLOYMENT

1. Northeastern University, Boston, MA Nov 2015 – Present

Residential Safety Supervisor

2.5E Ltd, London, U.K. Sep 2013 – Aug 2014 Employment Advisor and Trainer

3.Creative Support Ltd, Manchester, U.K. Nov 2012 – Sep 2013

Sr. Community Development Worker

4.Creative Support Ltd, Manchester, U.K. Dec 2009 – Nov 2012 Mental Health/Social Inclusion Support Worker

5.Lifeline Hospital, Mumbai, India. June 2006 – Aug 2008

Healthcare Assistant

Provided basic health check-ups such as blood pressure, diabetes, first aid and some essential vaccinations

Collected and examined various bodily fluids and tissue samples

Supported pediatric and geriatric patients within the hospital setting

Assisted patients with their participation in a trial concerned with the development of hand sanitizers as member of the clinical development team with strict adherence to GCP guidelines

Successfully coordinated clinical trials through communication with sponsors

Submitted regulatory documentation to sponsors and agencies for approval

Prepared and completed regulatory related reports

Maintained and organized study regulatory binders, and entered all required study data

Managed and reported data, collected source documents, implemented CFRs

Executed adverse events reporting, filing and archiving of study records

6.K.K. Maternity Hospital, Mumbai, India. June 2006 – Aug 2008

Healthcare Assistant

Provided basic health check-ups

Supported pediatric and geriatric patients within the hospital setting

7.Dr. Raju Shah’s Private Clinic June 2006 – Aug 2008

Healthcare Assistant

Provided basic health check-ups

Booked appointments and advised patients with respect to their medication and tests

LANGUAGES

English (fluent), Gujarati (fluent), Hindi (fluent), Urdu (fluent), Marathi (fluent)

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