Page * of * Preetha David

PREETHA DAVID

Email ID: ac947g@r.postjobfree.com

Mobile: +1-732-***-****

Profile

Over 2 Years of experience in life science field include Clinical Trial Associate, handling cell culture techniques, animal cell culture, biophysical techniques, biochemical techniques and biotechnological skills.

Academic Chronicle

Master of Science in Bio Chemistry from Bharathidasan University – India.

Bachelor of Science in Bio Chemistry from Manonmaniam Sundaranar University

– India.

Engagement experience

Extensive hands-on experience in Molecular biology and Clinical techniques.

Strong planning skills and Detail oriented.

Documentation submission.

Clinical trial and budget management.

In depth knowledge and understanding of ICH GCP guidelines for conducting clinical trials.

Case report form using oracle Clinical Application.

Primary/Secondary cell culture and cell thawing- Griess assay, wound healing assay, cGMP estimation.

Separation of biomolecules by TLC, Column chromatography and SDS PAGE, Agarose gel electrophoresis.

Immunological Technique-ABO blood grouping, Immunodiffusion techniques Bio-Informatic tools (blast, FASTA, Genome analysis, Protein structure prediction, similarity searching and homology tool).

Performed Laboratory calculations. Good knowledge and exposure to Biotechnology, Cell biology, Clinical biochemistry, Human physiology, Molecular biology, Cell Signaling and Immunology.

Expert in Micro soft word, Excel and Power point . Page 2 of 3 Preetha David

Professional experience

Sollers College, New Jersey, US (Oct 2018 to Present)

•Working as Clinical Trial Associate in Clinical Trial Management at Sollers.

•Maintain complete, accurate and timely data and essential documents in systems utilized for trial management using CRF, eCRF’s

•Preparation of Investigator Brochure, Clinical trial Protocol, Informed consent form, Case report form, and all regulatory submissions for IND application and NDA applications.

•Utilized understanding of human subject protection for clinical trials, ethical and regulatory compliance of US FDA/ICH/GCP regulatory requirements and IRB functions, HIPAA and more.

•Proficient in clinical trials contracts, vendor management, Trial Design, Roles and Responsibilities, Clinical Trial Phases, Site Selection, Site Management, Site Initiation to Closeout, Trial Monitoring, Source Data Verification (SDV), Standard Operating Procedures

(SOPs), Contracts and Budgets, Quality Assurance & Audits, Site Master File (SMF) and Trial Master File (TMF).

•Organized and analyzed reports for efficacy and safety for the new development product.

•Database management with Oracle Clinical.

•Knowledge in IVRS/ IWRS, Data cleaning, writing queries, review regulatory binders, data verifications using CTMS tool.

CSIR OPEN SOURCE DRUG DISCOVERY, India (June 2013 to Oct 2014)

- Worked in Bio-Informatics tools include BLAST and FASTA.

- Done project in Mycobaterium tuberculosis genome.

MIT AU-KBC Research Centre, Chennai, India (June 2011 to March 2013) EFFECT OF MICROGRAVITY ON CONTRACTILE CARDIOMYOCYTES CELLS AND NITRIC OXIDE IMPLICATION under the guidance of Dr. Suvro chatterjee, Vascular biology lab, AU-KBC Research Centre, Chennai, India

Nitric oxide played an important role in cardiac functions and is produced by the cardiomyocytes cells. NO at low concentrations protects cardiomyocytes from ischemia/ reperfusion- injury via soluble guanyl cyclase activation and cGMP regulated pathways . This study is aimed that understanding the effects of microgravity on the production of nitric oxide thus affecting cardiomyocyte functions and whether addition or depletion of nitric oxide is beneficial in restoring the normal cardiac function. Results show that under microgravity, the production of nitric oxide is higher. Roles& Responsibilities:

- Worked as Junior Research Associate.

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- Hands on experience in microbial, mammalian cell culture and molecular recombinant.

- Hands-on laboratory experience with capillary and gel-based electrophoresis, static.

- Strong basic molecular biology skills including PCR and DNA cloning.

- Good experience in cell line development for recombinant protein expression.

- Experience in protein purification and analytical techniques.

- Experience setting up and operating lab instrumentation Accolades & Training:

• Undergone Clinical Trial Management Training course from Harvard school.

• Presented white paper at national level seminar in modern biology (Mar 2007)

• Presented white paper at national level seminar on the topic of Colloquium on In Vitro Toxicology and Vaccinology (October 2010)

References : 1. Prof.R.Vasanthi Nachiappan,

Professor and Head,

Department of Biochemistry,

Bharathidasan University,

Tiruchirapalli,

India.

2. Dr. Babu Rajaendran,

Professor,

Department of Environmental Biotechnology,

Bharathidasan University,

Tiruchirapalli,

India.

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