Brijmeet Nagpal

*****, ******* ****, *******

Phone: 416-***-**** ON, L7C 3P4 E-Mail:ac4i52@r.postjobfree.com

Summary of qualifications:

Able to work under minimal supervision, with excellent organization, planning and problem solving abilities, and analytical skills.

Bachelors in science.

Established interpersonal and organizational skills.

Proficiency with MS Office, MS Word, Excel, PowerPoint.

Ability to multi-task with strong organizational skills and able to work effectively and efficiently

Basic medical and business knowledge.

Understands and can apply knowledge of clinical trial designs to trial execution.

Knowledge and experience in international standards (GCP/ICH), international (FDA, EMEA) and local regulations.

Flexibility with scheduling of work hours and potential for occasional “on –call” availability

Trained under supervision to carry out Laboratory Investigations and Contamination Control.

Cross-trained other department staffs in Microbiology to allow for work flow continuity

Trained for Transportation of Dangerous Goods

Projects: Efficacy of the lowering effect of PROLIPOSTAT® on Blood concentrations of low-density lipoprotein cholesterol (LDL-C) in patients with normal and elevated blood concentrations of LDL-C: A Double-blind, controlled Phase II study (Randomized comparative method, multi-center study)

Education:

Bachelor of Science, 1996, MD University, Rohtak, India

Masters in Eng Lit, 1999, MD University Rohtak, India.

Post Graduate Diploma in Public Relations, 2001, YMCA, New Delhi India

Certifications:

CRA Professional Development Program, 2017

Kriger Research Center, Inc. Toronto

Certification in HIPPA Compliance from HCCS

CPR and First Aid For HCP

Transportation of Dangerous Goods

Work Experience:

Research Assistant, Canadian Cardiovascular Research Network, Brampton, ON Present

Inform patients or caregivers about study aspects and outcomes to be expected.

Code, evaluate, or interpret collected study data.

Collect, organize, manage and enter data into paper and electronic case report forms.

Prepare Research Ethics Board (REB) communication including submission of protocol.

Preparation of shipments of biological samples from study participants.

Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.

Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.

Communicate with laboratories or investigators regarding laboratory findings.

Solicit industry-sponsored trials through contacts and professional organizations.

Order drugs or devices necessary for study completion

Communication with study monitors and participation in monitoring visits.

Direct the requisition, collection, labeling, storage, or shipment of specimens.

Register protocol patients with appropriate statistical centers as required.

Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms

Ongoing studies:

Smoking cessation

Start Birth Cohort

Clinical Research Associates, Medanta-The Medicity Dec 2009 - Aug 2015

Assisted in generation and review of source documents and CRF guidelines.

Prepared for and conducted on-site qualification, study initiation, interim monitoring and close-out monitoring visits to investigator sites.

Primary contact with the Sponsor following all aspects of clinical monitoring.

Maintenance of essential regulatory documents for ongoing trials.

Prepared study documents, Study Reference Manual, and Confidentiality Agreements.

Site and investigator selection, coordinated and conducted site initiations, periodic monitoring, site close-outs, safety and efficacy monitoring, regulatory review, source data verification, data query resolutions, and QA audits.

Extensive on-site monitoring and management knowledge.

Prepared and processed regulatory documents such as FDA forms 1571, 1572, Investigator’s CVs, Informed Consents, IRB Approvals, Investigators Brochures, Case Report Forms, and Serious Adverse Event Tracking.

Help manage and report on the conduct of clinical studies, as directed and assisted in writing clinical trial reports.

Medical Technologist (Bacteriologist), Jeewan Mal Hospital Sep 2001-Nov 2009

Edit and review laboratory procedures and policies for performance improvement. Review and interpret the Commission of Laboratory Accreditation checklist for conducting laboratory inspections.

Trainer for Becton Dickenson Phoenix Automated Microbiology System and Epicenter.

Participate as an active user of Laboratory Information Systems and Microsoft Office Applications.

Stocking checking and ordering of reagents and chemicals & performing molecular diagnostic tests for infectious viral diseases.

Reporting of laboratory results to the chief technologist and pathologist.

Responsible for receiving human biological samples, patient/specimen data entry, accurately labeling of samples, and document imaging for reproductive and oncology-related tests.

Complete specimen intake, which includes properly labeling each specimen and assuring each specimen, is properly prepared for processing.

Answer telephones, maintain logs/records, organizational skills, proficiency with numbers, research information, time management, use computerized databases, written and verbal communications.

Communicate in a professional and courteous manner with all individuals as necessary to obtain information for laboratory records, explained procedures, and elicited cooperation including monthly attendance at Infection control meetings and pharmacy meetings.

References Available Upon Request

Contact this candidate