Medical Device Clinical Research

Avanti Deshpande

**B smith St, Boston, MA ***** ************@*****.*** 617-***-****

https://www.linkedin.com/in/avanti-deshpande

EDUCATION

Northeastern University Dec 2017

Masters in Regulatory Affairs for Drugs, Biologics and Medical Devices Coursework: (Human Experimentation, New Drug Development, Strategic planning and project management, Medical Device Development, FDA law, Emerging trends and issues in Medical Device Technology)

Rashtrasant Tukdoji Maharaj University Jun 2013

Bachelor of Pharmacy

Coursework: (Pharmaceutics I-III, Pharmaceutical Analysis I-IV, Pharmacology I-IV) WORK EXPERIENCE

Integra Technologies Apr 2018 till date

Role: Clinical Research Associate

Managing site progress by tracking regulatory submissions, Case report form completion (CRF), Informed consent forms, Data inquiry resolution and Patient recruitment for Clinical Trials.

Reviews Regulatory Documentation, verifies investigator records and assisting in writing clinical trial protocols and informed consent forms.

Assists in managing investigational product supplies at trial site level, keeping sites informed of drug lots/ batches and expiration dates.

Consistently performing duties within established Standard Operating Procedure and in accordance with Good Clinical Practice (GCP).

Helping in development of study plans and timely submission of documents to TMF. D.B Tejani (Lion’s) Cancer Detection Center Trust Oct 2013 to Dec 2014 Role: Hospital Pharmacist

Entered new patient profiles and prescriptions into medication input software system.

Regularly completed paperwork and entered prescription and billing information into patient profiles.

Maintained updated records such as pharmacy files, patient profiles, charge system files, inventories and drug registries. .

Maintained proper storage and security conditions for chemotherapeutic drugs, laboratory and clinic agents.

ACADEMIC WORK AND PROJECTS

Accustomed to US FDA regulations, Health Canada and Australian regulations.

Have an overview of regulation pertaining to Clinical Trials, IRB review, IND Safety Reports, Form 1571 356(h), Form 1572, 510(K) submissions, Premarket submissions including review and approval process, Mock projects on Clinical Protocol Filing, Filing IND, ANDA, NDA, and BLA, ISO13485, Quality Assurance.

Drafted Mock projects on Regulatory strategy submissions, Conflicts of interest, Informed consent, Warning letter Analysis.

Drafted Due Diligence for Drugs of Alzheimer’s disease.

Presented an Emerging technology as a part of Digital Health on Inuslia Diabetes management, the need for this technology, Target population and regulatory hurdles and anticipated regulatory pathway.

Presented the strategic planning and processes of Global regulatory pathways for Class III Medical Device Approval (Canada and Australia, GHTF-STED).

Research Paper on “Rise in peanut Allergies among children’s in USA”

Research Paper on “Labelling Issues in Dietary Supplements in USA”

QC/QA analysis, M.S office (Word, PowerPoint, Excel), M.S Access. CERTIFICATIONS

Introduction to FDA Drug Review and Approval Process, Food and Drug Administration (2017)

Registered Pharmacist with “Gujarat Pharmacy council”.

National Institute of Health, “Clinical Research Training Certification”. CORE COMPETENCIES

ICH/GCP Guidelines HUD (Humanitarian use Devices)

HIPAA Compliance CMC data Collection

CFR Regulations GLP, GMP, cGMP

Medical Device reporting (MDR)

QSR Regulations

Contact this candidate