Quality Assurance Medical

DR. ARVIND K . PATEL

MD.,M.S. (Surg.)

Cell: 908-***-**** 32 Minebrook road, Apt # 88/A

Home: 848-***-**** Edison. N.J, USA-08820

Office: (908-***-**** *************@*****.***

QUALIFICATIONS SUMMARY:

• Strong experience with Clinical Trial Phases I-II-III-IV

• Extensive knowledge of GCP, GMP and FDA regulations

• Solid experience with EDC (InForm,Velos)

• Data quality, data completeness in Clinical Trial Management Systems for global studies

• Quality Assurance (CFR 21, Part 11)

• IT skills: Microsoft Office Suite including Excel, Power Point, Outlook, Access,, and

Quality Assurance software tools

EXPERTISE IN CLINICAL TRIALS:

• Oncology (Breast cancer, NSCLC, Colorectal cancer, Head & Neck )

• Neuro -Science

• GI (GERD)

• Cardiovascular (Hypertension, Arteriosclerosis and Atherosclerosis )

• Respiratory (Asthma)

PROFESSIONAL RESEARCH EXPERIENCE:

JFK Medical Center Edison,NJ

Clinical Monitor 09-2012 to till date

Research Associate

• Reviewed data on case report forms (CRF) as compared to source documentation for

correctness. Evaluated, tracking logs and diaries.

• Ensured all data is ‘clean’ and copies are collected as appropriate.

• Organized clinical data and arranged study archiving.

• Data entry in excel and comparisons.

• Prepare for publication and presentation

Oak Tree Patient Care PC Edison, NJ .

Physician Assistant 04/2011 to till date

• Medical management of patients

• New drug administration

• Management of adverse reaction

• Monitor Clinical trial s phase IV

Quintiles, Inc. University of Louisville

Research Associate 08/2010 – 03/2011

• Monitor a phase II open label multicenter study of Ontec in stage III and IV melanoma

patients

• Obtain, review for appropriateness, process regulatory and administrative documents

from/to investigator sites

• Process Serious Adverse Event (SAE) reports

• Assist in developing of eCRF pages based on protocols’ requirements for Pilot studies

• Use extensively EDC

• Perform drug accountability and reconciled of drug counts against source data and

dispensing log

Clinical trial Office University of Louisville

• Managed study conduct throughout a trial including: contacting and screening potential

subjects, preparing for each subject visit to ensure all appropriate procedures

• Worked with InForm, Phase Forward web- based data collection and management

software

Ashirvad Surgical Hospital & Endoscpy Clinic Patan, India

Attending- Onco surgeon 11/1989 to 02/2008

• Surgical management of patient

• Medical management of patient

• New drug administration

• Management of adverse reaction

• Monitor Clinical trials

CLINICAL RESEARCH:

09/2012-till date 2011 Research Coordinator,

Dept. of Neuro science, JFK Medical Center

Edison, NJ. USA-08820

08/2010 – 03/2011 Research Coordinator,

Clinical Trial Office, James Graham Brown Cancer Center,

University of Louisville, KY 40202 U.S.A

07/1987 - 09/1987 Junior Lecturer,

Clinical Trial Project (W.H.O.)

Gujarat Cancer & Research Institute,

Ahmedabad, Gujarat, India.380016

PROFESSIONAL EXPERIENCE

Clinical Experience in U.S.A

04/2011 – Till date Outpatient clinic- Internal Medicine

Oak Tree Patient Care PC, Edison, NJ

01/2009 - 08/2010 Outpatient clinic- Internal Medicine

Oak Tree Patient Care PC, Edison, NJ

03/2010- 08/2010 Maruti Family & Sleep Medicine

Freehold, NJ.

Clinical Experience in India

11/1989 - 02/2008 Attending onco surgeon

Ashirvad Hospital & Endoscopy Clinic,

Patan, Gujarat, India

01/1988 - 11/1989 Fellow in Surgical Oncology

Gujarat Cancer & Research Institute,

Ahmedabad, Gujarat, India.

TEACHING EXPERIENCE :

01/2012- 05/2012 American Institute of Medical Sciences

South Plainfield,

NJ. USA-08820

04/2010 – 08/2011 American Institute of Medical Sciences,

South Plainfield,

NJ. USA-08820

01/1984 - 09/1989 B.J.Medical College and Civil Hospital,

&

Gujarat Cancer & Research Institute,

Ahmedabad, Gujarat, India.380016

EDUCATION

01/1984- 12/1987 Masters in Surgery (M.S)

B.J.Medical College & Civil Hospital,

Ahmedabad, Gujarat, India.

01/1983 – 01/1984 Internship

Patan, Nadiad, Ahmedabad- India

06/1978- 12/1982 Bachelor in Medicine, Bachelor in Surgery (M.B., B.S)

B.J.Medical College & Civil Hospital,

Ahmedabad, Gujarat, India.

CERTIFICATION AND LICENSURE:

ECFMG Certified: November, 2009

Master of Surgery (M.S.): March, 1987

Bachelor of Medicine, Bachelor of Surgery (M.B.B.S): March, 1984

CLINICAL OBSERVERSHIP:

10/2009 - 03/2010 Memorial Sloan Kettering Cancer Center, New York, NY. U.S.A

12/2001 - 01/2002 Memorial Sloan Kettering Cancer Center, New York, NY. U.S.A

12/2001 - 12/2001 Christ Hospital, Jersey City, NJ.U.S.A

EDITORIAL POSITIONS:

01/2007 - 12/2007 Chairman, Gujarat State Surgeon’s Association Times.

PRESENTATION & PUBLICATIONS:

“East or West, You are the Best “ Mehsana, Gujarat India. November 2012

Exosomal-miRNA profiles as diagnostic and prognostic biomarkers in head and neck squamous cell carcinoma

(HNSCC).

Retrospective & prospective study of Renal cell Carcinoma, at ASI-Oncology

Pune, India. 1986

Modern Technology in Surgery -ASI- State Chapter Annual Conference

Mehsana, India. 1997

Skills:

Dedicated practitioner with a strong value added medical background in

Oncology. Skilled communicator, persuasive, and adaptable. Self-motivated

with high energy, initiative, and focused. Keen in-sight in to the needs and view of

others, able to listen and identify issues, or problem areas, and form innovative

treatments. Professional and articulate in presentations. Areas of strength include

comprehensive Medical Knowledge in total family care, oncology and urgent care,

Patient-Doctor relations, Problem solving/Decision making,

Presentations/Teaching, research, Communication/Negotiation/Facilitation,

Flexible/Assertive/Adaptable, and Commitment to provide quality healthcare,

Practice Management.

LEADERSHIP:

President, Gujarat State Surgeon’s Association, 2007

President, Patan Branch, Indian Medical Association. 2005

Secretary, Patan District Branch, Indian Red Cross Society.2007-2008

Board Member, Gujarat Society of Head & Neck Oncology.

PROFESSIONAL AFFILIATIONS:

Association of Surgeon’s of India.

Indian Association of Gastrointestinal & Endo Surgeons (IAGES)

Indian Society of Oncology.

Contact this candidate