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Burned Out in Spokane, Washington

79 months ago

Hello Everyone

There was recently a link provided in another discussion for free CRA training at NIH. I went into the website. While the website was useful, unfortunately, the training is for Principal Investigators not CRAs. I was very familiar with the free training for PI’s at NIH. However, here are some useful websites for the basics that CRAs need to know:

Human Participant Protections Education for Research Teams. Free self-paced course with a certificate that can be presented with your resume/CV
cme.cancer.gov/c01/nih_intro_01.htm

A Guide to Informed Consent: Every CRA should know this information about Informed Consents.
www.fda.gov/oc/ohrt/irbs/informedconsent.html

Guidelines for the Monitoring of Clinical Investigations: FDA recommendations for the monitoring of research sites. These recommendations are far different from what CROs and certification courses teach.
www.fda.gov/ora/compliance_ref/bimo/clinguid.html

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David in Los Angeles, California

79 months ago

Thanks a lot for the info. I wish I had this info before :(

Anyhow, I notice that when I try to fill out the registration for a new user (Human Participant Education program), they require me to list a facility. Uh, I'm not sure what to put there.

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kev in Brooklyn, New York

79 months ago

for those who are looking a break to get some clinical experience,

many large academic research centers in the USA, Johns Hopkins, MDAnderson, Sloan Kettering, etc all have entry study coordinator positions, they may have titles, ranging from assistant, associate to coordinator....all are basically sc positions as what they call in industry. They are always hiring because their typical applicant always leave after 1-2 year or so to med school or becoming cras in industry.

in industry, many large cros have entry positions call clinical research assistants, research associates, etc...again all entry and fairly easier to get with a bio related bs degree

2-3 years of clinical experiences from positions above will make your resume more marketable, hope it helps

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Burned Out in Spokane, Washington

79 months ago

David in Los Angeles, California said: Thanks a lot for the info. I wish I had this info before :(

Anyhow, I notice that when I try to fill out the registration for a new user (Human Participant Education program), they require me to list a facility. Uh, I'm not sure what to put there.

Hello David,

I cannot remember what I did for the facility information when I just signed up for the PI training. I think there may be a drop-down box or I may have just typed in NIH. I know it took some trial and error but it did go through. I am sorry that I cannot remember what I did.

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Burned Out in Spokane, Washington

79 months ago

Burned Out in Spokane, Washington said: Hello David,

I cannot remember what I did for the facility information when I just signed up for the PI training. I think there may be a drop-down box or I may have just typed in NIH. I know it took some trial and error but it did go through. I am sorry that I cannot remember what I did.

Hello David,

I just signed up again for the course. For the Facility I typed in National Institute of Health and I was able to get registered. I hope this works for you.

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SwissHam in Delaware

79 months ago

Hey Burned Out,

Regarding the ICF info, I have a CRA question: I was at a site a couple weeks ago and a page of the ICF was missing in the patient chart... I told the site to see if they can follow-up with the patient and obtain the page and have the patient initial it. I also asked the to write a note to file explaining the situation and why it went missing. If they cannot locate the page I am leaning towards a deviation that will need to be submitted to the IRB. It has been documented in the monitoring report and follow-up letters. Has this situation ever occured to you? Do you have anything else to add?

Thanks so much for all of your help, I appreciate it!

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Burned Out in Spokane, Washington

79 months ago

SwissHam in Delaware said: Hey Burned Out,

Regarding the ICF info, I have a CRA question: I was at a site a couple weeks ago and a page of the ICF was missing in the patient chart... I told the site to see if they can follow-up with the patient and obtain the page and have the patient initial it. I also asked the to write a note to file explaining the situation and why it went missing. If they cannot locate the page I am leaning towards a deviation that will need to be submitted to the IRB. It has been documented in the monitoring report and follow-up letters. Has this situation ever occured to you? Do you have anything else to add?

Thanks so much for all of your help, I appreciate it!


Hello Swiss Ham;
ICF pages go missing all the time. The problem is the subject likely just has a copy of the original missing page, so, the original that needs to be at the site may never be found, hence the site staff will never be able to verify they reviewed the page with the subject. I recommend that a complete new ICF be processed/signed by the subject. Both the first ICF with the missing page and the 2nd ICF will need to be in the source record. Your actions above discribe the correct path for documentation and IRB notification. However, some sponsors or CROs may actually classify this issue as a protocol violation rather than a deviation and they require seperate reporting timelines. I would check the Monitoring Plan to see if protocol deviations and protocol violations are defined differently and if the action plans are different. Sometimes protocol violations are actually called "significant protocol deviations" to avoid using the word "violation". This may be a deviation that will require the site staff to notify the medical monitor in addition to the IRB. The correct notification chain should be in the Monitoring Plan.
In addition to documenting the issue in your report and the source records, please discuss the issue in the follow-up LTR.

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SwissHam in Saint Paul, Minnesota

79 months ago

Hey Burned out,

Thanks very much for opinion - it definately is nice to hear a path to go on this one, I do appreciate the advice.
I know from one of your previous posts you are (and very rightfully) upset with how CROs conduct business and I agree - I mean once one CRO begins the under bidding processwhat can another do? It is kind of like the steroid problem, if someone is doing, the seemingly only thing you can do is do it as well to keep the playing field even.
Also, you most def. sound like you know your stuff - have you ever considered a position like a lead CRA or even project manager? I know they only specify travel as about 20% and you can do that home based?

Thanks again

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sarah in Bartlett, Illinois

79 months ago

hey i did my usmles n now before going into residency i would like to go for clinical research but i dont have any experience in this field can someone please guide me as to how to go about it . I would really appreciate the help
thanks

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Stefan Viziru in Edmonton, Alberta

79 months ago

Sarah, congratulations for your USMLE.

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sarah in Bartlett, Illinois

79 months ago

thankyou i wanted to ask you how to get into clinical research with no experience any clue please do let me know thanks

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sarah in Bartlett, Illinois

79 months ago

i really appreciate ure elaborate response thankyou so much . One of my friends told me to email the Dr.in the university campus who are carrying out the research it might take about 100 emails to get a single response so right now i am doing that lets see .I ll also do as you have recommended.
tc

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Cynthia in Somerset, New Jersey

78 months ago

Hello, everyone:

I am considering to enroll into a CRA certification program. Is there anybody to know the program offered by KRC International Center?

Thanks for information

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Ruby in Frisco, Texas

78 months ago

I have no background in healthcare can I still do the CRA training? I am yet to take the classes. Has anyone found any more free classes? Thanks for all your help and postings.

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Angela in Raleigh, North Carolina

77 months ago

i am very interested in making a career change and i am focusin on the clinical research field. i have a bs in biol and i have been in the QC and compliance areas of the pharma/biotech industry for the past 9 years. does anyone have any suggestions on how i can "break into" the clinical industry and if my background helps my chances? most positions that i have found require 2+ yrs of proven experience in clinical research. also, do you recommend taking any of the certification courses and if so, which ones? any assistance/advice/suggestions that anyone would be able to offer will be greatly appreciated!

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drkarthic in Madras, India

75 months ago

Hi, Any one can guide me .. I have 7 years of clinical experience as a dentist, any option to appear for the CRA certification exams directly.

regards,
Karthic

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PAULA CASALS in Lomas De Zamora, Argentina

75 months ago

I'VE RECENTLY FINISHED A COURSE OF CRA, BUT IN EVERY JOB THAT I APPOINT, THEY ASK ME FOR EXPERIENCE. HOW CAN I REACH MY EXPERIENCE IF ANYONE GIVES ME A CHANCE. HERE IN ARGENTINA I DONT KNOW WERE YOU CAN GET EXPERIENCE.

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Mindy in Vancouver, British Columbia

75 months ago

Can a foreigner with 1+ years experience of CRA for new drug clinical trials have a chance to apply a job in USA? Will be more chances to seek a job in the clinical trial If I pass the CRA exam of ACRP in a country other than USA?

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yuna in Seattle, Washington

75 months ago

sarah in Bartlett, Illinois said: i really appreciate ure elaborate response thankyou so much . One of my friends told me to email the Dr.in the university campus who are carrying out the research it might take about 100 emails to get a single response so right now i am doing that lets see .I ll also do as you have recommended.
tc

Hello Sarah,
I am in the same boat with you.
please let me know how things go with you.
please email me at liemb2000@yahoo.com

Thanks a lot.

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sarah in Bartlett, Illinois

74 months ago

hey i would like to read a sample for lor for clinical research if someone has a link please forward it to me.
thanks

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PAULA CASALS in Lomas De Zamora, Argentina

73 months ago

Do you mean that experience is not comprobable?

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robertn31 in Jersey City, New Jersey

73 months ago

Does any ony know of any search firms or agencies that specialize in Clinical research in New York or New Jersey? Is there any way to obtain a list of CRO's in New York or New Jersey? I tried googling but was unable to find anything.

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PAULA CASALS in Lanús, Argentina

73 months ago

you can search in google in international biopharmaceutical association and there you will find an item Contract Research Organizations,

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robertn31 in Jersey City, New Jersey

73 months ago

Thank you

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Jazz in Morristown, New Jersey

73 months ago

I have been reseraching CRA schools in NJ, and so far found www.craschool.com

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KC Temple in Towson, Maryland

73 months ago

Jazz:
I took an online Clinical Research course at Michigan State University. The lectures and exams are all done through your computer. It was a great course and they helped me with job listings and resume review. And I got to put a real university certificate on my resume.

RobertN31: Check with Thompsons.com- they have lists of CROs, recruiters, etc.

Good luck.

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PAULA CASALS in Lanús, Argentina

73 months ago

thank you for the information

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Tim Hanson in Troy, Michigan

73 months ago

I was wondering if anyone knows what a eCRO is? In the posting above at American Scitech International it says you will be placed at an eCRO??? I dont quite understand that!!?

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PAULA CASALS in Lanús, Argentina

73 months ago

I only know what a Contract Research Organization is, it is an organization that has the Human resourse for the developement of a clinical trial, that is: CRA's Study Coordinators etc. But I dont know what eCRO means.

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RK in Harrison, New Jersey

73 months ago

PAULA CASALS in Lanús, Argentina said: I only know what a Contract Research Organization is, it is an organization that has the Human resourse for the developement of a clinical trial, that is: CRA's Study Coordinators etc. But I dont know what eCRO means.

American Scitech Institite is a SCAM--They take ur money and dont help you at all!
Stay away from them.
--A former student of Scitech

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Jackie in New Brunswick, New Jersey

73 months ago

Tim Hanson in Troy, Michigan said: I was wondering if anyone knows what a eCRO is? In the posting above at American Scitech International it says you will be placed at an eCRO??? I dont quite understand that!!?

eCRO stands for electronic data capture Clinical Research Organization. In an eCRO alot of the essential documents, for example the Case Report Form (CRF) can be filled out directly on the computer rather than in the paper form, therefore, allowing monitors to be able to view the information from a secure computer systerm. In addition, labs will be set up directly to the computer system so that you can view the source documents from the computer system. It allows for quicker data analysis, less paper work (just think a Phase 3 trial could have 8000 patients= alot of paper work), it also allows for additonal monitoring because CRAs can view the information when they choose. I am an intern at American Scitech which is an eCRO.

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Gaurav in Corvallis, Oregon

73 months ago

Hello All,

My name is Gaurav and I will be completing my PhD in Pharmacology. I wanted to shift from basic research to clinical research and looking for clinical trials management/clincial research associate as one of the good options for me. Can anybody suggest me how can I enter into this industry considering the fact that I will be needing H1 visa.

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Olga in Hackensack, New Jersey

73 months ago

Does anyone know Medical Research Management Inc.? They have courses: first part -on line and second - hand-on 2 weeks training at different locations across the US. I need to decide asap, because there is deadline for hand-on courses.
Thank you.
Olga.

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Olga in Hackensack, New Jersey

73 months ago

Does anyone know the CRA on hand program in American Inst of Pharmaceutical Technology? What is the quality?
Thank you.

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Olga in New York, New York

72 months ago

Michelle Santoro in Rahway, New Jersey said: Hi Olga-

I think you are asking about American Scitech Institute of Piscataway, NJ. I am the enrollment advisor and would be happy to explain the program in detail to you in addition to connecting you with some current students and interns. Please feel free to email me at msantoro@americanscitech.com.

Thanks

Michelle

Hi Michelle,
No, I am asking about American Inst of Parm Technology (AIPT). Heardquarter is in Hackensack. I really need more info about this program, because it is located right near me and they provide hand-on experience.
I've already read about your program, it is too long (about 1 year)and too far from me. I work full time.
So, please, if you have any info about AIPT, please let know.
Thank you.

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sanghamitra in Philadelphia, Pennsylvania

72 months ago

robertn31 in Jersey City, New Jersey said: Thank you

Hi

Clinwell research Inc. do train people in Clinical Research its a 3 months program and they do help in job placements as well.

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sam in Mississauga, Ontario

72 months ago

sanghamitra in Philadelphia, Pennsylvania said: Hi

Clinwell research Inc. do train people in Clinical Research its a 3 months program and they do help in job placements as well.

hai sanghmitra
plz can u give the details of the program. I am interested in cra program.
thanks
sam

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pace_62 in Richmond, British Columbia

71 months ago

I am from Canada and I am interested in attending American Scitech research institute in NJ since they said they'll provide paid internship. But the US economy is so bad now, I don't know if it would affect the CRA industry. I am not sure if I should considering relocate. Does anyone can suggest the future or prospect of this industry. Thanks!

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Angela in Jersey City, New Jersey

71 months ago

Clinwell research provides online project internship. I know I met their staff who would also provide internship in medical writing, QA, site selection, screening and monitoring.Jersey city office staff are expert rather Piscatway branch.

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Mani in Sykesville, Maryland

71 months ago

Jazz in Morristown, New Jersey said: I have been reseraching CRA schools in NJ, and so far found www.craschool.com

Be careful, there are a lot of rumors about the school. You ask them to show enough proof that they have projects and verify them.

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sumedha in nutley, New Jersey

71 months ago

Hi there,
I want to undergo a CRA training for pharmaceutical career. I recently heard of Espoirbridge and came to know that they are a complete fraud after reading one of the Indeed forums. It's really difficult to find out which is a genuine training institute. As I do not have any hands-on experience with pharma, I can not apply for ACRP or SoCRA certification.

Can anybody tell me about ClinfoSource online training? Does anybody have any experience with their training? Does it help for getting a job?

Thanks in advance

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KC Temple in Towson, Maryland

71 months ago

Hi Sumedha:
Here is a link to Michigan State University's CRA training course: msustatewide.msu.edu/resource.asp?ResourceID=2394

The course is great. It's through an accredited university and offers job search help, but no internships. I took it about a year ago and learned alot.

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Helen in Perkasie, Pennsylvania

71 months ago

Save your money don't even think about it.
American Scitech is misleading potential students.

1. The Clinical Research Associate (CRA) training program lacks structure and organization. There have been 4 classes and a syllabus summarizing the topics covered along with the course timeline has not been distributed to date.
2. Class instruction time is not as advertised. It either starts late or ends early or in some cases both.

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pace_62 in Princeton, New Jersey

71 months ago

Hi Helen,

You take their course before?

Helen in Perkasie, Pennsylvania said: Save your money don't even think about it.
American Scitech is misleading potential students.

1. The Clinical Research Associate (CRA) training program lacks structure and organization. There have been 4 classes and a syllabus summarizing the topics covered along with the course timeline has not been distributed to date.
2. Class instruction time is not as advertised. It either starts late or ends early or in some cases both.

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ranga nori in Sayreville, New Jersey

71 months ago

KC Temple in Towson, Maryland said: Hi Sumedha:
Here is a link to Michigan State University's CRA training course: msustatewide.msu.edu/resource.asp?ResourceID=2394

The course is great. It's through an accredited university and offers job search help, but no internships. I took it about a year ago and learned alot.

Have you got a job through this course or just learnt a lot?

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brad__ in Princeton, New Jersey

71 months ago

Are you still in that batch? Can you get their internship? I guess the schedule doesn't matter as long as they get you a paid job. What do you think?

Brad

Helen in Perkasie, Pennsylvania said: Save your money don't even think about it.
American Scitech is misleading potential students.

1. The Clinical Research Associate (CRA) training program lacks structure and organization. There have been 4 classes and a syllabus summarizing the topics covered along with the course timeline has not been distributed to date.
2. Class instruction time is not as advertised. It either starts late or ends early or in some cases both.

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ranga nori in Sayreville, New Jersey

71 months ago

Helen in Perkasie, Pennsylvania said: Save your money don't even think about it.
American Scitech is misleading potential students.

1. The Clinical Research Associate (CRA) training program lacks structure and organization. There have been 4 classes and a syllabus summarizing the topics covered along with the course timeline has not been distributed to date.
2. Class instruction time is not as advertised. It either starts late or ends early or in some cases both.

Hi Helen, i am considering them, you seem to know a lot about them, this msantoro says that your batch is getting internship in Jan. Are you getting the internship too? Thanks for your reply, in advance.

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KC Temple in Towson, Maryland

71 months ago

ranga nori in Sayreville, New Jersey said: Have you got a job through this course or just learnt a lot?

Rangi:
Hi. They gave me some leads, but I found this job myself. I don't think I would have been hired without the course, though. It definitely helped me interview better and be more prepared to do the job. The course is terriffic and a good university certificate looks great on the resume! Good Luck!

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Salman Mahmood in Piscataway, New Jersey

70 months ago

eTele CRA Program - Clinical Research Associate Training (CRAT)
CRAT program is an Innovative and enhanced Online training program with Web Based Tele-Conference Classes. Our eTele Program is designed for pharmaceutical professionals or fresher who intend to pursue their career as Clinical Research Associate, Drug Safety Personal or Pharmacovigilance Officer in field. This course is best suitable for candidates with PhD/Masters/Degree in Pharmacy, Nursing, Medicine (MBBS), Biotechnology, BDS, Life Science and Microbiology or Relevant Science background. This is a life time initiative program from Qtech Solutions Inc, New Jersey, USA., to build your career in clinical research (Clinical trials, Drug Discovery, Pre-Clinical Studies). Learn this program direct from professional in the field.
For more details of our eTele CRA program :
Visit our website or click on link www.qtech-solutions.com/ecraonline
Our training and support is focused to help you understand about Clinical Trials Phases (I - IV), Drug Discovery, Clinical Research Activities, Investigator-Subject-Site Selection Process, Safety and Efficacy Studies & Reporting, Site initiation, Monitoring and Close Outs, Pharmacovigilance and Regulatory Submissions, ICH and FDA Guidelines/SOPs and many more.
The Advantage:
* Learn from professionals in the field.
* Learn from home and shape your career.
* Attend Web Based Tele-Conference Classes from home per schedule.
* Tips for getting Started / Resume Preparation.
* Get your Narratives prepared for interviews and mock interviews.
* Qtech Certified Certification as CRA
Other Benefits as Employee:
* H1B Sponsorship (USA)
* Green Card
* 401K Retirement plans
* Medical Benefits
* Life Insurance
Our Introductory e-Tele CRA program costs you only $751 for a 60 days Online Access. For Further Details - Please call or email to :
Salman Mahmood: salman.mahmood@qtech-solutions.com

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Salman Mahmood in Piscataway, New Jersey

70 months ago

sumedha in nutley, New Jersey said: Hi there,
I want to undergo a CRA training for pharmaceutical career. I recently heard of Espoirbridge and came to know that they are a complete fraud after reading one of the Indeed forums. It's really difficult to find out which is a genuine training institute. As I do not have any hands-on experience with pharma, I can not apply for ACRP or SoCRA certification.

Can anybody tell me about ClinfoSource online training? Does anybody have any experience with their training? Does it help for getting a job?

Thanks in advance

Hi Sumedha,

I see that you are interested in undergoing a CRA training for pharmaceutical career. I work for Qtech Solutions Inc, NJ and I have just posted information about our e-Tele CRA program. It is really rewarding in terms of building your career in clinical research (Clinical trials, Drug Discovery, Pre-Clinical Studies). The highlight of this course is "Online training program with Web Based Tele-Conference Classes. Our eTele Program is designed for pharmaceutical professionals or fresher who intend to pursue their career as Clinical Research Associate, Drug Safety Personal or Pharmacovigilance Officer in field."

It costs you only $751 for a 60 days Online Access. This will include 6 Web based Tele-Conference Sessions for class-room presentations and sessions for Course Clarifications, Discussions and to provide additional information. A Toll-free call-in number and web meeting details will be provided for enrolled participants to attend these classes per schedule.
For Further Details - Please email to:salman.mahmood@qtech-solutions.com

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