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Clinical Research Project

Location:
New Castle, Delaware, United States
Posted:
November 28, 2018

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Resume:

Subhasree Natarajan

ac7tlc@r.postjobfree.com

Newark, Delaware, Ph: 959-***-****

Professional Summary

Excellent verbal and written communications with the ability to clearly and persuasively express both my own and other’s ideas.

Thrives in both independent and team environments

Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint and Graph pad Prism.

Obtained Distinction in typing skills.

Worked closely with the Dean of the Department and handled the project works like preparation of materials for research meetings, acted as point of contact for Provost and Vice Chancellors Office.

Individually handled and coordinated the activities of clinical study participants.

Performed selection, initiation, monitoring, and closeout visits for the study participants.

Managed site progress by tracking regulatory submissions and case report form (CRF) completion.

Maintained medical device, investigational product and inventory.

Monitored follow-up activities including visit reports and follow-up letters.

Managed all clinical monitoring activities and the overall site management ensuring compliance with Good Clinical Practices (GCP).

Coordinated with Biostatisticians to complete the statistical analysis of the clinical data obtained.

Responsible for preparation of the budget for the specific study.

Solely handled plant tissue culture lab and techniques.

Experience in Microsoft Office, Excel, PowerPoint, Graph pad prism and SPSS.

Experience in writing and reviewing Standard Operating Procedures (SOPs).

Reviewed documents such as work orders, logbooks, and reports to ensure compliance with specifications, regulations and procedures.

Experience in different plant extraction methods.

Have hands on experience in animal cell culture techniques, DNA and RNA isolation.

Have hands on experience on microbiology techniques.

Have done gene polymorphism study in diabetic patients.

Knowledge in PCR, RT-PCR, ELISA techniques, gel electrophoresis, SDS-PAGE, Western Blot.

Have presented and submitted project reviews to Department of Science and Technology, Government of India.

Prepared project proposals for submission to various organizations like DBT, DST, ICMR etc.,

Experience in preparation of documents related to clinical trial like CRP, SOP as per ICH guidelines.

Have enrolled patients in clinical trial as per the inclusion criteria

Experience in phase II clinical trial.

Organized medical camps for the recruitment of patient population for the trial.

Have experience in designing and planning clinical trial projects.

Assisted in the development of protocols, case report forms, informed consent forms, and IRB materials

Thoroughly communicated with principal investigators and their staff members to resolve data

Organized the scheduling of clinical trials, assisted in the screening of patients and the development of protocols

Experience in reviewing scientific literature

Conducted pharmacological (toxicity study) study as per OECD guidelines.

Monitored, reviewed and finalized study protocol, clinical trial documents and reports.

Experience

Quality Support 3, Siemens Healthineers – Newark, Delaware. (August 2018 to Present)

Responsible for maintaining standard operating procedures and worksheets for Reagent Manufacturing in Documentum.

Coordinates documentation needs for new or revised products.

Interacts with all functional groups within Reagent manufacturing to ensure document availability based on business needs and in compliance to Quality System requirements.

Multitasks and type accurately and at a speed that would support the work flow.

Scans documents into the Document Management System, updates logs, retrieves materials requested by other areas and supports the organizations records needs as required.

Documentation Specialist in Sanofi Pasteur, Rockville, MD, July 2017 – September-2017

Maintained company related documents (QC docs, Log books, BPR’s etc.)

Filed all documents and kept organized.

Received, processed and Recorded Documents and also scanned the documents for transferring to Document Management System.

Completed file audits and requests for missing documentation.

Retrieved documents when needed by management.

Prepared, edited and maintained standard operating procedures (SOP).

Used various software (i.e. word processing, spreadsheets, database, email, data collection software) related to manufacturing duties.

Entered data in project batch records and gather other data as needed to complete related reports.

Maintained and Conducted document revisions for batch records and manufacturing procedures.

Maintained the documents related to preventive and corrective actions related to manufacturing.

Completed regular chart audits and filled out requests for any missing documents.

Collaborated with all levels of company

Coordinated the documentation necessary for new or revised products and also maintained the documents as per the quality system requirements.

Maintained file room and stored files in file boxes.

Maintained all records and updated systems to reflect newly added files.

Established good sound and secure document tracking and management system.

Tracked and communicated documentation status.

Conducted Documentation audit

Junior Research fellow, in the project “ National Facility for conducting clinical trial” funded by Department of Science and Technology, Government of India, 2010-2015, SRM University, India.

Pursued PhD in the title “Role of a polyherbal formulation in the prevention and management of type 2 diabetes mellitus and associated vascular complications.

Provided direct assistance to professor in research institute by preparing project proposals, experimental procedures and analyzing data to compose scientific research papers.

Created clinical project documents according to the protocol, including, but not limited to, source documentation forms and guidelines, monitoring Standard Operating Procedures (SOPs), monitoring visit templates and reports.

Executed and supervised 3 clinical research studies at a time, from recruitment of subjects to end of study.

Recruited more than 150 patients for clinical trial.

Designed source documents required for clinical research study thereby optimizing the amount of correct data captured at each patient visit.

Advised Principal Investigator on decisions such as trial acquisition, advertising and patient interactions.

Maintained the worksheets related to reagent preparation and also prepared the reagents required.

Assisted in the preparation and coordination of Investigator Meetings, attend, and present at Investigator meetings as required.

Have presented and submitted project reviews to Department of Science and Technology, Govt of India.

Participate in study training programs and maintain awareness of developments in relevant field of clinical research.

Communication with various teams to ensure proper execution and conduct of the clinical trial to generate quality clinical data.

Assisted in the development of protocols, case report forms, informed consent forms and other study related documents in accordance with GCP regulatory requirements.

Conducted and assisted with administrative activities as a member of the project team.

Monitored the progress of clinical research activity.

Presented the project in ethics committee for approval of clinical trial.

Prepared and reviewed study-related documents.

Handled patients directly and kept track of their treatment and reported to the investigator.

Participated in medical camps for recruitment of patients for clinical trial.

Have hands on experience in animal cell culture like HepH2, 3T3-L1, IMR-32 etc., cells and isolated DNA and RNA from plants and human blood.

Have done gene polymorphism study in diabetic patients.

Have run PCR and gel electrophoresis for about 1000 human blood samples, Knowledge in ELISA technique (for various inflammatory parameters).

Prepared documents necessary for conducting clinical trial i.e documents for ethics clearance, and documents like informed consent and CRF.

Conducted day-to-day execution of clinical research protocols including obtaining informed consent, completing study procedures, and dispensing, accounting for study drug, and documenting drug compliance.

Ensure subject safety and adverse event reporting to sponsor and IEC.

Verified drug accountability logs and storage requirements.

Conducted telephone interviews to determine subject eligibility. Schedule intake appointment to recruit subjects to study. Obtain informed consent conduct intake interview, and enroll subjects.

Have involved in pharmacokinetic study, both in drug-to-drug interaction and drug to herb interaction.

Education Interdisciplinary Institute of Indian System of Medicine SRM University, Kattankulathur, Tamilnadu, India

PhD, Dept of Biotechnology, 2010-2016.

Vels College of Science, Chennai, Tamilnadu, India (Affiliated to Madras University)

Master of Science in Biotechnology, 2007-2009

Ethiraj College for Women, Chennai, Tamilnadu, India (Affiliated to Madras University)

Bachelor of Science in Biochemistry, 2004-2007.

Master of Science in Biotechnology 2007-2009, Vel’s College of Science, Tamilnadu, India

Carried out project on the title “Quantification of Eugenol in Callus and Wild Leaves from Ocimum Sanctum and Ocimum Americanum”

Have experience in plant tissue culture like callus formation, root and shoot formation.

Abstracts presented in conferences

Subhasree. N, Shivapriya Shivakumar, Aruna Agrawal, Nirupama Dubey, G.P. Dubey Homocysteine concentration responsible for neurodegeneration among type-2 diabetes mellitus, At national conference (NIACON), Jaipur. 2011

Subhasree. N, Aruna Agrawal, K. Ilango, R.G. Singh, G.P. Dubey.. Type-2 diabetes and impairment of cognitive-motor functions-benefits of an Ayurvedic formulation. At national conference (NIACON), Jaipur 2011

Shivapriya Shivakumar1, Subhasree. N, Aruna Agrawal, K.S. Laxmi and G.P. Dubey. Inter-relationship between hsCRP and adiponectin among Senile Dementia cases.. At international “brain aging symposium 2010” BHU

N. Subhasree, Aruna Agrawal, K. Vasanth, K. Ilango, Dubey G.P: Inflammatory biomarkers associated with diabetes mellitus and risk of coronary heart disease- Benefits of Seabuckthorn. Proceedings of National Conference on Seabuckthorn “Emerging Trends in R&D on Health Protection & Environmental Conservation. CSK Himachal Pradesh Agricultural University, Palampur, pp.189-197, December 1-3, 2011.

Dubey GP, Agrawal A, Subhasree N., Ilango K, Singh RG. Role & Scope of Ayurveda in Management of Lifestyle Disorders with special reference to Madhumeha. Scope and Role of Ayurveda in the Management of Lifestyle Disorders, NIACON, National Institute of Ayurveda, Jaipur, pp. 53-63; 2011.

N. Subhasree, Aruna Agrawal, K. Vasanth, K. Ilango, Dubey G.P: Inflammatory biomarkers associated with diabetes mellitus and risk of coronary heart disease- Benefits of Seabuckthorn. Proceedings of National Conference on Seabuckthorn “Emerging Trends in R&D on Health Protection & Environmental Conservation. CSK Himachal Pradesh Agricultural University, Palampur, pp.189-197, December 1-3, 2011

Shivapriya S, Subhasree N, Agrawal A, Laxmi KS, Dubey GP. Inter-relationship between hsCRP and adiponectin among senile dementia cases. International Symposium on Brain Aging and Dementia: Basic and Translational Aspects, November 29-30, 2010.

Subhasree N. Agrawal A, Ilango K, Singh RG, Dubey GP. Type-2 diabetes and impairment of cognitive-motor functions benefits of an Ayurvedic formulation. Scope and Role of Ayurveda in the Management of Lifestyle Disorders, National Institute of Ayurveda, NIACON, Jaipur 14th -15th March 2011.

Vasanth K, Shivapriya Shivakumar, Subhasree N, Aruna Agrawal, and G.P. Dubey: Management of Risk Factors Associated with Coronary Heart Disease by Hippophae rhamnoides. Proceedings of National Conference on Seabuckthorn “Emerging Trends in R&D on Health Protection & Environmental Conservation. CSK Himachal Pradesh Agricultural University, Palampur, pp.310, December 1-3, 2011.

Gomathee R, Subhasree N, Karthikeyan S and Rajagopal K (2010). Plant regeneration from stem nodal segments of Ocimum sanctum Linn. through direct regeneration. Proceedings of International Conference on “Medicinal Plants and Herbal Drugs: Challenges and Opportunities in Cultivation, Sustainable Utilization and Conservation”, Pachiyappa’s College, Chennai, India, pp. 53.

Gowri K, Rajagopal K, Karthikeyan S and Subhasree N (2010). In silico analysis of Eugenol extracted from Ocimum sanctum Linn. as an potent therapeutic agent. Proceedings of International Conference on “Medicinal Plants and Herbal Drugs: Challenges and Opportunities in Cultivation, Sustainable Utilization and Conservation”, Pachiyappa’s College, Chennai, India, pp. 109

PUBLICATIONS

In vitro assessment of antibacterial and antioxidant activities of fruit rind extracts of garcinia cambogia. L. Shivapriya shivakumar, S. Sandhiya, Subhasree. N, Aruna agrawal, G.P. Dubey. International Journal of Pharmacy and Pharmaceutical Sciences, Vol 5, Issue 2, 2013

In vitro antioxidant and antimicrobial potential of bambusa arundinacea (retz.) Wild, Sandhiya S, Subhasree N, Shivapriya Shivakumar, Aruna agrawal and G.P Dubey, International Journal of Pharmacy and Pharmaceutical Sciences, Vol 5, Issue 2, 2013

In vitro antioxidant and antibacterial activities of Salacia species – A comparative study. Subhasree. N, Shivapriya shivakumar, Sandhiya, Aruna agrawal,G.P Dubey, International Journal of Pharmacy and Pharmaceutical Sciences, Vol 5, Suppl 2, 2013.

Evaluation of plant based formulation on adolescent obesity and its associated bio-markers: A randomized, double blind, placebo controlled study, Shivapriya Shivakumar, Kaliappan Ilango, G. P Dubey, N. Subhasree, Aruna Agrawal. Complementary therapies in Medicine. DOI: 10.1016/j.ctim.2015.01.012.

Antioxidant and antihyperglycemic activities of a US patented novel polyherbal formulation in high fat diet/STZ induced diabetic rats. Subhasree.N, Ilango Kaliappan, Aruna agrawal, G.P Dubey, Antidiabetic, International Journal of Pharmacology.

PAPERS UNDER THE PROCESS OF PUBLICATION

Therapeutic potentiation of glucose uptake in 3T3-L1 cell line using hydroalcoholic extract of polyherbal formulation. Subhasree. Natarajan, Ganesh Munusamy Ramanujam, Mohankumar Ramasamy, Ilango Kaliappan, Govind Prasad Dubey. Journal of herbal medicine.

Lagerstroemia parviflora therapeutically alters glucose metabolism in mouse pre adipocyte cell line, Subhasree. Natarajan, Ganesh Munusamy Ramanujam, Mohankumar Ramasamy, Ilango Kaliappan, Govind Prasad Dubey. Journal of Pharmaceutical and biomedical analysis.



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