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Clinical Research Medical

Location:
Minneapolis, Minnesota, United States
Posted:
March 06, 2018

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Accomplishments

Professional Summary

Skills

Work History

BHUVANESHWARI JAMINDAR GANESH

**** **** *** *, *** 816, Edina, MN 55435 • Cell: 612-***-**** • ac4pvm@r.postjobfree.com Awarded as Clinical Research Coordinator (CRC) by WHO team in the study entitled ‘AN OPEN LABELLED, RANDOMIZED, MULTICENTRE, COMPARATIVE STUDY TO EVALUATE THE IMMUNOGENICITY AND REACTOGENICITY OF INACTIVATED POLIO VACCINE (PANACEA BIOTEC LTD.) WITH IMOVAX POLIO

(SANOFI PASTEUR INDIA PVT LTD) IN INFANTS. ' by contributing to the collection, compilation, documentation, and analysis of this clinical research which led to determining the effectiveness of polio vaccine. Clinical Research Specialist having extensive project experience from concept to development with areas of expertise include writing protocols, assessing and monitoring serious adverse effects, preparing clinical study and safety reports. Worked in assisting design, schedule and data process for a pharmacokinetic and pharmacodynamic study. Collaborated with the Principal Investigator to respond to audit findings and implement approved recommendations. Have good knowledge on institutional animal care and use committee protocol, ICH/GCP Guidelines, medical terminologies and code of federal regulations for human subjects. Serious Adverse Event (SAE) reporting

Thorough knowledge of FDA, ICH/GCP, GMP

principles and regulations

Documenting and assisting in clinical research and trials

Statistical Analysis, Data Monitoring and Data

Integrity

Knows, understands and abides by the components

of the FAIR Shake and by SOPs.

Strong analytical, research, and trial preparation skills

Medical Terminologies

Therapeutic and protocol knowledge

Subject Recruitment, Screening and Data

management

Good communication, IT & administrative skills

Willingness to adapt and learn, with kindness

CLINICAL RESEARCH SPECIALIST, 05/2016 to 08/2017

Sri Ramachandra Medical College and Research Institute – Chennai, INDIA Open-labelled, randomized, comparative, multicenter study to compare the immunogenicity and reactogenicity of IPV of Panacea Biotec Ltd. with WHO pre-qualified Imovax Polio of Sanofi Pasteur India Ltd. The primary objective of the study is to demonstrate non-inferiority of the test vaccine to the reference vaccine, with 90% power and alpha set at 0.025. The study will also evaluate the common local and systemic reactogenicity and lot-to-lot consistency of test vaccine.

Responded effectively to protocol violations and afforded lab reports, pharmacist analysis, and product recommendations to prescribers, resulting in maximization of patient care and minimization of associated costs from adverse drug reactions and or ineffective therapies. Collected, reviewed and maintained regulatory documents and performed IRB submissions. Monitored data expeditiously to reduce data discrepancies; collaborated with both the sites and data Ensured compliance with the CRF's and protocols

Reviewed essential/regulatory documents, ensuring Investigator Site Files (ISF) are accurate, current and identical to Trial Master File (TMF)

Education

Work Authorization

Additional Information

Prepared and Provided timely reporting of subject safety, adverse events (AEs), serious adverse events (SAEs) and protocol violations to sponsor and IRB

Assisted in on-site monitoring of clinical trials including review of source documentation, development of protocols, case report forms (CRF), regulatory materials and drug accountability Maintained working knowledge of all applicable FDA regulations and ensure compliance with current FDA Regularly performed Investigator Product Accountability during monitoring visits Maintained database of patients information, Analyzed data collected from patients during the clinical research trial. Established and maintained trial master files in digital and physical formats Performed site initiation, subject recruiting and routine monitoring. PHARMACY SPECIALIST, 06/2012 to 05/2016

Sri Ramachandra Medical College and Research Institute – Chennai, INDIA Preparing and dispensing prescribed drugs and medicines, while also maintaining pharmacy supplies and records. Prepare, control and issue pharmaceutical products, also evaluate orders to verify dosage, dosage regimen, and quantity to be dispensed. Instructions to patients regarding medication consumption and side effects. Perform quality control checks on medications.

Prescription dispensing/compounding, Inventory control, Product safety, Patient counseling, Tablet dilution for Pediatrics, Total Parenteral Nutrition (TPN) for Neonatal Intensive Care Unit (NICU). Dosage calculations for Oncology patients of any age group, Antibiotic auditing, ADR's processing and reporting, Drug Therapy Decision Making with sound knowledge on Interpretation of Laboratory Investigations. Design suitable Pharmacotherapeutic Regimens for the patients by retrieving and integrating patient data.

Worked in ambulatory/outpatient environment and inpatient/hospital setting. Focused on Drug and Poison Information Centre (DPIC) for answering emergency calls and suggest plans for handling exposures to toxins, chemicals or life-threatening drug interactions by providing up to date information about drugs, poisoning, and its toxicology. Worked in the area of Pharmacovigilance. Molded me in providing Discharge Counseling on medications, diet and lifestyle modifications for the inpatients. Doctor of Pharmacy (Pharm.D.): 2017

Sri Ramachandra University - Chennai, INDIA

GPA: 3.4/4.0

Authorized to work in the US

HONORS AND AWARDS 2015: Awarded Second place for Presenting a Poster/Paper on ADR Monitoring. 2014: Awarded First place for Presenting a Case on Drug-induced Rheumatoid Arthritis and Osteoporosis. PROJECTS AND PUBLICATIONS Completed Academic/coursework titled “Assessment of Relapse Rate in Alcohol Dependence Syndrome Patients with and without treatment of Disulfiram”. Duration: 11/2015 - 4/2016. Completed a systematic review on the “Comparison of the efficacy of inhaled corticosteroids with that of the second and third line asthmatic agents” - a meta-analysis. POSTER/PAPER PRESENTATIONS 2015: Presented poster on ADR Monitoring at Sri Ramachandra University, Chennai, Tamilnadu, India. 2013: Presentation on Medication Errors at PSG Institute of Medical Sciences and Research, Coimbatore, Tamilnadu, India. COMMUNITY SERVICES Volunteered and participated in Eye Donation Camps, Diabetic Awareness Rally, Urban and Rural Health Camps, Eye Donation Fortnight Program.



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