Research Associate III (Molecular Medicine)

ADITI JHAVERI

** **. ******* ****** ***. # *, Phone: 857-***-****

Boston, MA-02115 Email: *************@*****.***

SUMMARY

M.S Pharmaceutical Sciences graduate with excellent GPA, 1.2 years of work experience (Clinical Research) and over 2 years of intensive laboratory experience in oncology (Basic research). I am looking to join a Pharmaceutical or Clinical Research Company or an Academic Institute which offers a challenging work environment well suited to my knowledge and skills.

CORE COMPETENCIES

Basic Research: Cell Culture, DNA isolation, gel electrophoresis, Fluorescence/DIC Microscopy, Liposome preparation and characterization, proficient in using the microplate reader and basic lab instruments.

Clinical Research: Medical Writing, Documenting, ICH-GCP regulations, meeting deadlines, producing quality documents.

EDUCATION

Northeastern University, Boston, MA Dec 2008

Masters in Pharmaceutical Sciences

Major: Pharmaceutics and Drug Delivery Systems

GPA- 3.79

Bioinformatics Institute of India Dec 2005

Industry Diploma in Contract Research and Clinical Trials

Grade: A (71.5%) (Correspondence course)

North Gujarat University, Gujarat, India Jun 2004

Bachelor of Pharmaceutical Sciences

First Class with Distinction (73.5%) (University gold medalist)

WORK EXPERIENCE

Beth Israel Deaconess Medical Center, Boston Apr 2009- Current

Center for Vascular Biology Research

Research Assistant III (Molecular Medicine)

Job profile: Carrying out molecular biology experiments (PCR, Minipreps, maxipreps, restriction digests, gel electrophoresis, bacterial transformations, cell culture, transfections, FACS), general lab maintenance.

Lab Experience at Northeastern University Jan 2007- Jan 2009

Worked on MS thesis project under the guidance of Dr. Robert Campbell in the Department of Pharmaceutical Sciences at Northeastern University, specializing in drug delivery and targeting in oncology (familiar with basic and advanced concepts in oncology), formulation development, in vitro studies (cell culture), in vivo studies employing SCID mice for imaging using MRI.

Thesis: “Magnetic Nanomedicine and Hyperthermia for the Treatment of Thyroid Cancer”

Veeda Clinical Research (India) Pvt. Ltd. (CRO) Dec 2005- Jun 2006

Sr. Research Assistant (Medical Writer)

Job Profile: Medical writer (preparing clinical study reports & case report forms for bioequivalence studies as per ICH-GCP and CTD guidelines, managed dispensing, dosing and retention of investigational drugs and maintained records in the pharmacy briefly.

Duties:

• Prepared reports for pilot as well as pivotal bioequivalence studies tending to requirements of sponsors as well as to the guidelines outlined in the CTD for submission to Indian and US regulatory authorities.

• Executing and planning the completion of study reports as per ICH guidelines in a timely manner and communicating with the project manager for updates.

• Communicated on a daily basis with the bioanalytical and biostatistical departments so as to incorporate their respective inputs into the final clinical report on a timely basis for submission.

• Preparing appendix documents for the clinical study reports as needed.

• Responded to queries from QC and QA department for modifications to clinical study reports.

Workshops attended: Foundations of Clinical Research & ICH-GCP Guidelines sponsored jointly by Aceas Clinical Research and Veeda.

Recognition: Deming Quality Award Apr 2006

Vibgyor Research Support Services, Ahmedabad, India (SMO) Feb 2005 - Oct 2005

Research Assistant

Job Profile: Study coordinator for Phase III international cardiovascular clinical trials and some first-in man device trials, coordinated the overall conduct of studies with respect to documentation and correspondence with study monitors and sponsors, and communicated with patients, principal investigator and IRBs regularly.

Duties:

• Maintaining the study site file and updating it as needed.

• Filling and submission of necessary trial documents including FDA 1572.

• Reporting SAEs to the sponsor electronically.

• Keeping a track of patient enrollment and follow ups for trials.

• Thorough documenting of informed consent for enrolled patients.

• Entering information in case report forms and transmitting it to respective trial authorities

• Randomizing patients using IVRS.

• Making sure that there were no deviations to the clinical study protocol when enrolling patients as per the stated inclusion/exclusion criteria.

• Thorough understanding and execution of clinical trial protocols.

• Familiar with all study related documents including Investigators brochure, trial protocol, case-report forms, study site file, informed consent forms.

• Processing and shipment of biological specimens to central labs.

• Responding to queries related to the trial from the study monitor.

• Familiar with registration of IRB with OHRP for obtaining FWA.

• Submission of interim reports and SAEs to IRB.

• Participation in study start-up and study-completion meetings.

• Conduct of study as per the protocol, SOPs and GCP guidelines.

Industrial training/Internship during graduation

Maan Pharmaceuticals, Mehsana, India 3 months

Troikaa Pharmaceuticals Ltd. Ahmedabad, India 1 week

Observed manufacturing processes for tablets and injections, aseptic techniques, microbial assays, documentation and company SOPs.

TECHNIQUES AND COURSES

Techniques: UV Spectrophotometric analysis, TLC, disintegration and dissolution studies, Cell culture techniques, colorimetric assays, maintaining cancer as well as endothelial cell lines, media preparation, preparation of liposomes (characterizing for size, charge and phase transition temperature), sonication, centrifugation, dialysis, fluorescence polarization studies, and fluorescence microscopy, FACS (basic knowledge).

In vivo techniques: Handling frogs (isolated and perfused organs), SCID mice (measuring body weights, tumor volumes, s.c injections in mice), complying with the animal protocol

Instruments: UV Spectrophotometer , fluorescence microscope, micro-plate reader (FLX 800, µQuant), particle size and zeta potential analyzer, pH meter, rotary evaporator, autoclave, centrifuge, freeze dryer, disintegration and dissolution apparatus, ultra-sonicator, Remon Ultrasonic System for measuring pulmonary artery pressure (Remon Medical Technologies, Israel), BD FACSCalibur, BD FACS Canto.

Computer Skills: Microsoft Office (Word, Excel, PowerPoint, Outlook) and Internet applications.

Software: SPSS 15.0, 16.0 (Statistical Package for Social Sciences), CellQuest Pro, KCJunior data analysis software, IPLab imaging software, BDFACS Diva.

Courses: Advanced drug delivery, Pharmaceutical analysis, Pharmacology, Pharmaceutical and Medicinal Chemistry, Drug Discovery and design, Biochemistry, Molecular Cell Biology, Clinical Pharmacy, Pharmaceutics, Biostatistics, Human Anatomy and Physiology.

ACHIEVEMENTS

• Second prize at State Level Paper Presentation Competition organized by GUJCOST for the paper “Pharmacy Education in India- Current Problems and Suggested Solutions”

• 1st prize at the Elocution Competition organized by Indian Pharmaceutical Association (IPA) at College level.

• Awarded Dr. P.D. Patel Medal for standing first in the Second Year B.Pharm.

• Awarded a gold medal for standing third in the Final Year B.Pharm and Late Shri Dahyabhai Patel medal for securing the highest marks in Biopharmaceutics and Dosage Form Design.

• Awarded the “Deming Quality Award” at Veeda Clinical Research (Awarded for demonstrating outstanding sense of quality and perfection at work)

HONORS/AWARDS

• Phi Kappa Phi Interdisciplinary Honor Society April 2008

PROJECTS AND PRESENTATIONS

• “Pharmacy Education in India-Current Problems and Suggested Solutions” oral presentation at State Level Competition organised by Gujarat Council of Science and Technology (GUJCOST), 2003

• Submitted a thesis on ‘Pulmonary Drug Delivery Systems’ (Pharmaceutics) to the North Gujarat University for the partial fulfilment of Bachelor’s Degree in Pharmacy (Apr 2004).

• “Development of Magnetic Cationic Liposomes for the treatment of thyroid cancer”-Poster presented at Northeastern University Research Expo March, 2008 and at ISPE poster competition (Boston Chapter) April, 2008

• “Magnetic nanomedicine and hyperthermia for the treatment of thyroid cancer”-Poster at Pharmaceutical Sciences Department Showcase, Northeastern University, May 2008 and AAPS Annual Meeting, Atlanta, GA, Nov 2008.

AFFILIATIONS

• Member, Phi Kappa Phi Interdisciplinary Honor Society.

• Founder member, All India Medical Writers Association (AIMWA).

• Life member, SKPCPER Alumni Association & Research Society (SAARS).

• Student member, International Society of Pharmaceutical Engineering, (ISPE) Boston Chapter.

• Student member American Association of Pharmaceutical Scientists (AAPS).

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