Clinical Research Medical

Abm Shafayet

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

Brooklawn, NJ-**030

********@*****.***, Ph- 856-***-****

Summary:

I am a foreign medical graduate with a background in Clinical Research. I have completed my Bachelor of Medicine and Surgery (MBBS) from M A G Osmani Medical College, Sylhet, Bangladesh, in 2006 and worked as a physician in Bangladesh from 2007-2011. I came to USA in 2011. I passed USMLE step 1 in 2013. In Usa I did clinical observeship under Dr. Mashiul Chawdhury MD ( Cancer treatment center of America, Philadelphia, PA) and Under Dr. Linda Girgis ( Family Practitioner at South River, NJ). I am also certified in health informatics from Drexel University, Philadelphia, PA. At present I am doing my Masters in public health course under Walden University.Currently I am working as a clinical research coordinator at Massachusettes Eye and Ear Infirmary, Boston, MA). In addition to experience in patient management as a physician, I have experience in all phases of the clinical trial (from phase I-phase IV). I have conducted in-house monitoring and generated timely and accurate monitoring reports. I am currently at Brooklawn, NJ available immediately for a phone interview and willing to relocate

Technical Skills:

Data Collection and Entry

Quality Improvement

ICH GCP Guidelines

Trial Master File (TMF)

EMR (Epic,Nextgen and other)

HIPAA

Microsoft Office Proficient

Resolution Management

SOP writing

Project Management

Recruting subjects following inclusion/exclusion critera per protocol

Documentation & Reporting

EDC, Oracle Clinical CTMS

Data review

Trouble shooting for data discrepancy and data integrity

Aggregate reports

Review of Contract and Budget

Microsoft Office

Monitoring safety by tracking adverse effect

Share point

Education:

Master of Public Health- part time student, Walden University, Minneapolis, Minnesota-5540, 2015-Pres

Bachelor of Medicine and Surgery (MBBS), M A G Osmani Medical College, Sylhet, Bangladesh, 1999-2006

Internship:

Clinical Trial Intern, Soller’s college, Edison, NJ-08837, 2017-2018

Medical intern 2006-2007

Clinical clerkship/obsership:

Dr. Mashiul Chawdhury MD

Department of infectious disease,

Cancer treatment Center of America

Philadelphia, PA- 19124

Ph- 856-***-****

Dr. Linda Girgis

Family practioner

Girgis family medicine

171 main st, south River, NJ-08882

Ph- 732-***-****

License and Certifications:

Certification in Bachelor of Medicine and Surgery, Sylhjet, Bangladesh 2006

Post Graduation Certificate in internal medicine, Bangladesh 2008

Registered Pharmacy Technician by NJ Board of Pharmacy

Certification in Computer Office Application, Comilla, Bangladesh

Post-Bachelor Certification in Health Informatics- Drexel University, Philadelphia, Pa-19104, 2017

GCP certified from MAssachusettes general hospital 2019

CITI certified 2019

Research Experience_

1.A multi-center, randomized, double-masked, placebo controlled clinical trial of suppressive valacyclovir for one year in immunocompetent study participants with an episode of dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis due to Herpes Zoster Ophthalmicus (HZO) in the year prior to enrollment, PI- Dr. James Chodosh, MD, MPH

2.Effects of Autologous Serum Drops on Dry Eye Disease due to Ocular Graft-versus-host Disease: Principal Investigator: Dr. Reza Dana, MD, MPH, MSc

3.Small-Fiber Polyneuropathy in Patients with Dry Eye Disease; Site Principal Investigator: Jia Yin, MD, PHD MEE; Jane You, MD BIDMC

Including them, I was also part of the study stuff for some more investigator initiated and sponsor initiated studies. As a study coordinator I manage the site initiation visit, site maintenance visit and site closing visits. I am able to make a long-term relationship with my patients and complete each scheduled study visits successfully. I also manage regulatory documents and subject folders for each definitive study and submit required documents to IRB in a timely manner.

Professional Experience:

Clinical Research study Coordinator, 05/19-6/20

Massachisettes eye and ear Infirmary ( Harvard Medical School)

Boston, MA- 02114

Lead study coordinator at Zoster Eye Disease Study, PI- DR. James Chodosh, MD, MPH

Lead study coordinatror at small fiber polyneuropathy, PI- Dr. Yen

Lead study coordinator at Autologus serum Drop study- PI Dr. Reza dana

Experience of conducting site initiation visit, site monitoring visit

Maintaining submission of all the regulatory documents amd maintaining data query to run a study smooth

Maintain signal detection process to check adverse events

Subject data review

Coopersurg Family Practice, PA 01/19-5/20

Respiratory center coordinator

Worked for Medservices LLC

Insurance verification of patient’s documents

Taking nasal swab and running molecular test (PCR) and uploading the test result into the EMR.

Maintain the correlation between patients, providers and corporate.

Daily reporting of inventory and patient test results.

Recording upper respiratory tract infection data and submit it to clinical research department for research purpose.

Sollers, Edison, NJ ( Online Remote Job) 07/18-12/18

Clinical Research (Intern)

Sollers is an organization specializing in graduate certificate programs in clinical research, clinical trial management, drug safety and pharmacovigilance.

Conducted in-house monitoring and generated timely and accurate monitoring reports.

Got trained in all phases of clinical trial (from phase I-phase IV)

Uploading and tracking regulatory documents in Trial Master File (TMF)

Reviewed and reconciled all essential documents of the Trial Master File (TMF) in compliance with SOPs, GCP and ICH Guidelines.

Reviewed study case report forms (CRFs) completed by the investigative sites and verified entries by validating accurate source documentation to support CRF entries.

Collected IRB approval documents from any amended protocol, Informed

Consent form, Investigator Brochure and any other subject facing material

Performed regulatory binder review and retrieved documents, as appropriate for study TMF.

Reviewed all SAEs, ensured Medical Director sign-off, and checked that sites are notified and that all company procedures are complied with.

Reconciled the usage of investigational products at the site.

Episource LLC, Gardena, CA 10/18-01/19

Medical Records Technician

Attending frequent meetings with health care professionals

Chart retrieval include- clinical documents, medications taking, imaging documents, laboratory documents.

Extract confidential data (medical records) from both the electronic (EHR) and paper documents and scan them, email them or save them into company database.

Strictly following the HIPAA and other confidential rules and regulations.

Cigna, Philadelphia, PA 12/17-06/18

Data Entry Associate

Extract the confidential health related data from the raw database, and enter them into the company database for the pharmacist or the physician to review

Application of ICD-9 or ICD-10 codes using Microsoft access

Completing the assigned project within the time frame

Deborah Heart and Lung Center, Browns mills, NJ 11/16-12/17

Pharmacy Tech

Pharmacy data entry

Preparing medications following aseptic precautions

Completing the assigned project

Rite Aid Pharmacy, Camden, NJ 05/14-11/16

Pharmacy Tech

Answering phones, insurance enquiry, data entry

Following HIPAA, preparing and dispensing medication

Wendy’s, Sicklerville, NJ 06/11-03/14

Crew Member

Customer service

Taking orders and preparing food

CD Path and Hospital, Bangladesh 08/06-01/11

Physician

As it is a specialized cardiac hospital, we must save all our data and send it to NICVD (National Institute of Cardiovascular Disease), Dhaka, Bangladesh for their research purpose.

As an attending physician have to manage all the patients and their attendees and make an appropriate treatment and recovery plan.

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