1. Kampeshkumar shah
Apt# 1101, 40-stevenson road,
Etobicoke, ON, M9V 2B2
Phone# 4167407791, cell-647 401 7791
Email:- krshah26@yahoo.co.in
Objective- Seeking position of MEDICAL LAB.TECHNOLOGIST AND OR ‘CLINICAL RESEARCH
ASSOCIATE.’
PROFESSIONAL PROFILE - B.SC. WITH MICROBIOLOGY, Diploma in ‘CLINICAL RESEARCH- CRA
(AAPS), STANDARD FIRST AID CPR/AED LEVEL-C, HCP
20 Years experience of running own computerized clinical laboratory as a LABORATORY SCIENTIST at .
INDIA
• Prepared reagents, reconstitute solutions and calibrated, controlled and validation of experiments.
• Extensive experience in following established lab. Methods-modern Auto-analyzer systems.
• Hands on Auto-analyzer skills and trouble shootings.
• .familiar to adhere company protocol
• Comprehensive knowledge of GCP-ICH.
• Strong understanding of FDA, HC regulations and their applicability in Clinical Research
• Able to follow, implement, write, and review SOPs and other clinical research documents as: ICF,
protocol, reports, and regulatory documents.
• Experienced in Data collection, management, resolution, and AE/SAE writing and reporting.
• Knowledge of Clinical Trail Supplies Management, including drug accountability.
• Outstanding ability to analyze, gather, write, evaluate and produce detailed reports on a variety of
projects. Expertise in collecting review and production of critical documents.
• Strong understanding of drug development process, collaborative opportunities, compliance, training,
data collection, source documentation, validation and personnel management.
• Highly organized, resourceful, self managed, detail oriented, with good problem solving skills and ability
to work under pressure and meet deadlines.
• Capable of being flexible in demanding situations and willing to learn new things.
• Excellent Interpersonal skills and Communicational skills.
PROFESSIONAL EXPERINCE / SOFT SKILLS
Knowledge of effective patient identification and recruitment criteria’s according to protocol
• Knowledge of informed consenting and ERB approval and reporting processes.
• Extensive experience in following established lab. Methods-modern Auto-analyzer systems.
• Hands on Auto-analyzer skills and trouble shootings
• Performed specific bl.tests as–HEMATOCRIT including HB, Total WBC, RBC, Platelets, Cell-morphology.
• Investigated blood/urine / sputum/semen/ stool samples to support doctor’s clinical diagnosis,
performing fever profiles like blood parasites (malaria), enteric fever (typhoid fever), urinary tract
infection (UTI), pneumoniitis, jaundice, tuberculosis and others.
• Coagulation study- PT, APTT, BT-CT.
• Bio-chemistries- performed with great care, authenticity& with quality control-quantitative measurement
of following investigation in blood/serum as per doctors requests.
• Blood glucose (fasting/post prandial/random sample- GOD-POD method).
• S.Protein, -- Total, albumin, globulin, a/g.
• S.Lipid profile- s.cholesterol, s.triglycerides, HDL, LDL, VLDL.
• Liver function tests- s.billirubin, SGPT, SGOT, S.Alkaline phosphatase, Australia antigen test (HBs Ag), urine
routine/micro.
• Renal function tests- s.creatinine, bl.Urea, blood urea nitrogen(BUN),
2. • S.Electrolites- Na+, k+, cl.
• All enzymes like amylase, isozymes like CPK-MB
• Good comprehension of the process of data acquisition, management and resolution.
• Preparing study progress reports and timely reporting AEs/SAEs, study specific documentations.
• Studying and reviewing site related documentations in adherence to GCP, SOP, regulatory requirements
and protocol guidelines.
• Familiar with cost estimation, resource allocation and planning of Investigators meeting.
• Designing, Preparing and reviewing IB, Informed Consent forms and Protocols.
• Knowledge of IATA shipping regulations, storage and distribution of IP and its accountability.
CORE COMPETENCES;
• Tactful and performance oriented.
• Knowledge of clinical trials, , solid understanding of ICH/GCP guide lines, strong verbal and
communication skills, effective self management and organizational skills, effective oral and written
communication skills with ability to communicate with medical personnel, strong customer focus and
excellent interpersonal skills, ability to prioritize work in order to meet demanding timelines.
• Highly creative, adaptive, think and act maturely.
• Prepared reagents, reconstitute solutions and calibrated, controlled and validation of experiments.
• Extensive experience in following established lab. Methods-modern Auto-analyzer systems.
• Hands on Auto-analyzer skills and trouble shootings
*ACCOMPLISHMENT –. Arranged several blood donation camps, collected thousands number of blood
bottles ,providing in an emergency situation for INDIAN RED-CROSS SOCIETY OF PETLAD branch. Attended several ‘
MEGA MEDICAL CHECK-UP CAMPS’ Organized by ‘ROTARY INTERNATIONAL CLUBS PROVIDED FREE SERVICES IN my
city as well surrounding villages.
• WORK HISTORY
• Alpa clinical laboratory, laboratory technologist, 1986 -2005 ( PETLAD, INDIA )
owner/director
• Other experiences
• Mobile Climate Control Inc. operator, bending and 2008 to 2009
CNC machine
• Coldmatic refrigeration operator, simimpianti
Foaming machine,
Metal bending
Shearing machine 2006 to 2008
• Phoscoat finishing Inc. Line man, rack line 2005 to 2006
• Give & go- prepared food helper, mixing dept. july-05 to sept-05
EDUCATION;
1982-83 Bachelor in science with microbiology Sardar Patel Uni. Anand, INDIA
1997-98 Post graduate diploma in medical lab. Technology Gujarat institute of technology, INDIA
PROFESSIONAL DEVELOPMENT-
March-10 Standard first Aid CPR/AED Level C, HCP CANADIAN RED-CROSS.
Feb-2010 Post graduate diploma in clinical Research. AAPS, ON, Canada.
March-2006 Clinical research phlebotomy Humber College, Etobicoke.
(Cline- 501 50)
3. 199
7-98 Post graduate diploma in medical Gujarat institute of technology,
Lab. technology, Baroda, India
VOLUNTEER—Served Indian RED-CROSS society as a BLOOD BANK Technician from 1983,june to 1986,june
performing duties as a MEDICAL LABORATORY TECHNOLOGIST and BLOOD BANK TECHNICIAN.
References available on request..