Administrative Assistant Clinical Research

Kshitija Rane

Phone: 408-***-****

********.****@*****.***

SUMMARY:

Expertise in development of small molecules, in-vitro studies, preparation of tablets, capsules, semisolids, cosmetics, analytical & stability study of drugs.

Excellent understanding of modern chemistry technology including IR spectrometer, gas chromatography, HPLC, and UV-vis spectrometry.

Strong understanding of ICH guidelines, drug discovery & development, SOP’s, GMPs, GLPs, pharmacovigilance, and federal regulatory requirements associated with pharmaceutical manufacturing.

Skilled in data management like merging, preparing RMDB, use case diagrams, Activity diagrams etc.

Effective team player with excellent communicational and interpersonal skills and strong leadership quality.

Capability in successful time management, problem solving and decision-making.

Experience in handling large amount of data.

Technical know-how of IBM SPSS, Oracle, SQL software

EXPERIENCE:

Research experience– University of Pune, India 2012 – 2014

Developed pharmaceutical product from concept formulation to final product.

Characterized and screened raw material by reviewing formulas and using analytical techniques for formulation of pharmaceutical product.

Performed stability study and analysis of developed final product using various analytical techniques such as UV visible, PH meter etc.

Ensured project adhered to GCP, FDA, ICH guidelines and pharmaceutical regulations; compliance with protocol, study procedures and SOPs.

Conducted in-vitro study of prepared formulation using various barrier membranes.

Tracked progress of project and initiated appropriate actions to achieve target objectives.

Cataloged results of tests in physical and digital formats.

Alzheimer’s Association, San Jose, CA 2015 – 2016

Administrative Assistant/ Liaison

Prepare spreadsheets, account payable filing of checks.

Recording of data on subsidiary ledger.

Updated resources to maintain resource library for helping community by providing them facilities like skilled nursing, physicians, lawyers etc. by 24*7 helpline.

Data entry in personify database to support community.

Ranjeet Enterprises Pune, India 2014

Administrative assistant

Provided analyst support in data reporting and analysis.

Maintained perfect file records ensuring important documents can be accessed quickly.

Prepared in voices for clients by mail merging.

Extensively used Visio to create Use Cases, activity diagrams, data flow diagrams and business process models.

Shriniwas Hospital, Pune, India 2013

Pharmacist

Organized and maintained new and existing patients record keeping including treatments and prescription orders.

Processed patient registration in a timely and accurate manner in the hospital registration system, including entry of cored diagnosis code and billing information.

Checked for completeness and accuracy of all new and refill labels and orders, reviewed content and accuracy of all drug packaging and labeling.

Serum Institute, Narayangaon, Pune, India. 2012

Laboratory assistant

Assisted in development and writing of new laboratory procedure and techniques.

Maintained quality control of all laboratory testing to ensure accurate and timely lab reporting.

Performed and/or assisted with laboratory procedure as assigned.

Operated and maintained lab equipments in proper condition, arranged for performing experiments.

COLLABORATIVE AND INSTRUCTIONAL SKILLS:

Supervised 2 students in an undergraduate project studying topical drug dosage form.

Worked closely with lab colleagues to conduct animal studies in Pharmacology section.

Provided guidance to undergraduate students in the laboratory study of biotechnology, microbiology and pharmaceutical coursework.

CURRICULUM/COURSES:

Organic Chemistry, Pharmaceutical Analysis (SEM, DSC, TGA, MS, GC, LC etc.), Pharmacology, In-vitro studies, Biochemistry (study of enzymes catalysis, photosynthesis, oxidation, energy production), Pharmaceutical Jurisprudence, Pharmaceutics, Microbiology (immunology, aseptic preparation), Bio pharmaceutics, Biotechnology (genetic engineering, plant cell & tissue culture, PCR, DNA, RNA).

EXTRACURRICULAR ACTIVITIES:

Registered Pharmacist, Maharashtra, India 2012

Introduction to Clinical Research, Indian Council of Medical Research 2011

Delegate, National Service Scheme. 2010

Zonal level project competition at Avishkar Research Festival, India. 2010

EDUCATION:

University of Pune, India

Master of Pharmacy (Pharmaceutics) 2012- 2014

Bachelor of Pharmacy 2008- 2012

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