Information Technology Clinical Research

JASKUMAR PATEL

Boston, MA

629-***-****

*****.***@*****.***.***

https://www.linkedin.com/in/jaskumar-patel

EDUCATION

Northeastern University, September 2017-Present

Master of Science in Regulatory Affairs in Drugs, Biologics and Medical Devices Major in International Regulatory Affairs

Northeastern University, Boston, MA, USA

Course Work

• Understanding on QSR 21 CFR 820, Understanding on 510 k and PMA database.

• Created Protocol, Informed Consent form, Investigational Brochure, SOP and Mock meeting request to FDA.

• Understanding on HIPAA, Belmont principle (21 CFR 50/54/56/312) and Clinicaltrials.gov, 45 CFR 46.

• Performed mock IND consultation, Public commenting on FDAs draft document, developed with ICH E6 Guidelines, Safety guidelines, Code of federal regulations, Drugs@FDA, 21 CFR 201,312.6 (Drug labeling) and Federal Registers, OTC.

• eCTD and Global biotechnology frame work (USA, EU and Japan) JSS College of Pharmacy,

Doctor of Pharmacy, (Pharm.D), June 2010-June 2016 Post Graduate Diploma in Pharmacovigilance, July 2015-June 2016 Course Work

Clinical Research, Pharmacotherapeutics, Pharmacoepidemiology and Pharmacoeconomics, Pharmacovigilance, Bio-statistics, Therapeutic drug monitoring, Worked as Intern in Oncology, HIV, Medicine, Neurology and Surgery. PROFESSIONAL EXPERIENCE

JSS Hospital: August 2015 - June 2016

Clinical Research Coordinator

• Managed source data/visit notes updates (medical and non-medical) and Investigator Site Files (ISF) during clinical trial.

• Analyzed suspected adverse drug reaction by using different Causality Assessments Scales throughout the year.

• Identified and reported suspected adverse drug reactions and reported through CIOMS and SUSARs throughout the clinical trial.

• Maintained the Case Report forms and updated patient visit records during clinical investigation. ACADEMIC PROJECTS

Major Project done on “Assessment of Potential Drug-Drug Interactions in Prescriptions of Patients with Chronic Diseases in Community Setting”

• Participated in poster presentation on " Assessment of Potential Drug-Drug Interactions in Prescriptions of Patients with Chronic Diseases in Community Setting"(Co-Author) At Krupa Nidhi college, Bangalore during my Internship. Minor Project done on " Assessment of price and Availability of medicine in India."

• Performed poster presentation on “Enabling patient centered care through health information technology". Indo-Us conference 2015, Mysore during Internship.

• Presented Poster on “Assessment of price of essential medicine in India” At IPC 2015, Mysore. VOLUNTEER EXPERIENCE

• Volunteered in 67th Indian Pharmaceutical Congress at JSS college of pharmacy, Mysore.

• Volunteered the Preceptor Development Program at JSS Hospital Mysore. CERTIFICATIONS

• American Heart Association Certified “BASIC LIFE SUPPORT” Healthcare Provider (AED and CPR).

• American heart Association Certified “Advance Cardiovascular Life Support Training”.

• National Institute of health “Protecting Human Study volunteer in Clinical Trials”. PROFESSIONAL SKILLS

• Effective written and oral communication skills.

• Effective analytical/problem solving skills.

• Regulatory Writing Skills.

• Computer: Microsoft Word/Excel/PowerPoint/outlook.

• Presentation Skills.

Contact this candidate