Richa Jaiswal

CLINICAL RESEARCH ASSOCIATE

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919-***-****

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aducvh@r.postjobfree.com

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Goose Creek, SC 29445

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PROFESSIONAL SUMMARY

A result Oriented Physician with 6 years of clinical Research Experience and 6 years of Clinical practice experience as a physician in India. Experienced in numerous therapeutic areas such as Oncology, neurology, respiratory diseases, gastroenterology, rare disease. Proficient in software and programs like SPSS, Veeva Vault, Medidata Rave, Review Manager, Comprehensive metanalysis, Endnote, Mendeley, and MS office. Expertise in the outcome, survival, predictive, and cost-effectiveness analysis, and management of clinical research studies.

SKILLS

Extensive knowledge of HIPAA (Health Insurance Portability and Accountability)

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NHANES (National Health and Nutrition Examination Survey) database

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Meta-analysis

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Proficiency in MS office

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Extensive Knowledge of ICH-GCP Guidelines

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Ability to work independently and in a team

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Excellent Interpersonal and communication skills

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THERAPEUTIC AREAS OF EXPERIENCE

Neurology: Alzheimer's Disease, Multiple Sclerosis

Infectious Diseases: Covid 19

Oncology: Neurofibromatosis, Breast Cancer, Solid Tumor, Prostate Cancer

Respiratory: COPD, Idiopathic Pulmonary Fibrosis (IPF)

Rare Disease: Cystic Fibrosis

TECHNOLOGY EXPERIENCE

IWRS: Almac, Clinphone

CTMS: Suvoda, Medidata

EDC: Rave, Impact Harmony, Veevavault

eTMF: Veevavault, Transperfect

PROFESSIONAL EXPERIENCE

CLINICAL RESEARCH ASSOCIATE I/II, CHARLESTON, SC

Worldwide Clinical, February 2019-Present

Designs data collection forms, known as case report forms (CRFs).

Coordinates with the ethics committee, which safeguards the rights, safety, and wellbeing of all trial subjects.

Manages regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs.

Identifies and assess the suitability of facilities to use as the clinical trial site.

Identifies/selects an investigator who will be responsible for conducting the trial at the trial site.

Liaise with doctors, consultants, or investigators on conducting the trial.

Sets up the trial sites - ensuring each center has the trial materials, including the trial drug often known as the investigational medicinal product (IMP)

Writes visit reports and file and collate trial documentation and reports

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CLINICAL RESEARCH COORDINATOR, SC

Medical University Of South Carolina, March 2017-February 2019

Responsible for assisting in the informed consent process, and screening potential patients for clinical trials.

Made prescreening calls, Data entry in EDC.

Attended research/clinic meetings and training bi-monthly or more as needed and required.

Responsible for Recording Screen Failure.

Data Management: Captured, maintained, and analyzed data for all the research patients and data entry in EDC.

GCP and HIPPA trained, SIVs, interaction, and submission to the IRB (Institutional Review

Board).

Did Randomization and maintained research records of study activity, including case report forms, drug

dispensation records, or other regulatory forms as per FDA (Food and Drug Administration)

guidelines.

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CLINICAL OBSERVER DEPARTMENT OF INTERNAL MEDICINE, ILLINOIS

University Of Illinois Urbana Champaign, October 2016-January 2017

Took history and performed the physical examination.

Participated in making the diagnosis with attending.

Wrote the SOAP (Subjective Objective Assessment and Plan) notes.

Educated the patient about diet and exercise.

Worked with the Medical Director in Methadone clinic Montefiore to get a good understanding of

opioid addiction and dual diagnosis in that patient population.

Attended morning rounds in ICU (Intensive Care Unit) and internal medicine floors with Dr. Alcaraz.

Presented patient cases and hospital protocols on various topics including the use of Xarelto in stroke

patients, interstitial lung disease, and current clinical trials.

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MEDICAL OFFICER, Delhi, New Delhi

ESI Hospital and Primary Care Clinic, September 2009-September 2015

ESI Model Hospital is a 300 bedded multi-specialty hospital with more than 100 combined internal medicine and, pulmonary medicine beds.

Used critical thinking when making a medical diagnosis and treated all patients.

On a regular outpatient shift, there are around 300 to 400 patients for four medical officers, two Senior residents, and two senior consultants.

Common patients' diagnoses include Coronary artery disease, Chronic kidney disease, COPD

(Chronic Obstructive Pulmonary Disease), Malaria, Dengue fever, Rheumatoid arthritis, Stroke,

Arthritis, etc.

On the night shift, attended medical emergencies in the ER (Emergency Room), participated during rounds of 100 admitted patients on the floor with senior Consultants and sometimes independently.

Evaluated Patients and ordered appropriate diagnostic/imaging tests.

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CERTIFICATIONS

ECFMG Certified

FSMB Certified

ICH-GCP Certified

VOLUNTEER EXPERIENCE

VOLUNTEER CLINICAL ASSISTANT, Columbia, SC

Helping Hands-Free Clinics, December 2015-August 2016

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CLINICAL ASSISTANT BIHAR

Nature Doctor's Clubs, December 2007-February 2008

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VOLUNTEER CLINICAL ASSISTANT NY

Clinic of Dr. Bangaruraju Kolanuvada

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REFERENCES

References available upon request

Contact this candidate