CRA Training - Schools in Canada?

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Saima in Toronto, Ontario

82 months ago

Hi urmila when i called kriger they said that it takes about 2 months to finish the course.I am still doing my MSc so I dont have 8 hours to put in a day.But I wanna finsih as soon as possible to get a job.Since I have to pay back loans that I will be getting to attend this course.

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Irina in Toronto, Ontario

82 months ago

Dear Saima,
Friend of mine finished this course exactly for two months 3 or 4 yers ago. I think it is possible.
Best regards ,
Irina

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Rafi in Toronto, Ontario

82 months ago

Hi Urmila where do you work.

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Urmila in Toronto, Ontario

82 months ago

Hi saima,
Oh ok.I didnt know you were still doing your post grad. Which university do you belong to?
Anyways best of luck in all your studies.

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Urmila in Toronto, Ontario

82 months ago

Hello Rafi- you have asked this a few times.I work in multiple places-doctors office,university.All are part-time contractual work.
I hope this answers your question.

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Irina in Toronto, Ontario

82 months ago

Hi Urmila,
I took Clinical Research programm at Kriger Center few weeks ago and I am planning to spend about 3-4 months for this course. I absolutely agree with you, this course is serious, but it depends on knowledge, background and experience. I have Parmacy background in Russia and Certified Pharmacy Technician lisence in Canada. I am working part time right now in Pharmacy.I hope that I have answered for your questions. Thanks for your comments,
Irina

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Urmila in Toronto, Ontario

82 months ago

Hi Irin,
You have a very good background and I am glad you are enjoying the CRA course. It doesnt matter where you do it from as long as you learn what is needed. You can still keep a look out for the jobs advertised in the pharmaceutical industry and apply. You never know when you may use your expertise.I have friends who didnt complete their full course and got employed and they finished it later.

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Rafi in Toronto, Ontario

82 months ago

I Guess I made this question for first time but thank you so much for your reply.I am working for a CRO right now. But not as a CRA I want to have monitoring experience can you sujjest me what to do.

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Irina in Toronto, Ontario

82 months ago

Hello Urmila,
Thanks for good words. I was laid off from small pharmaceutical company where I had position 'Clinical Data Coordinator' the end of October. Our study was put on hold. I decided to get more clinical knowledge and took Kriger course. Do you know other sites , except Monster or Workopolice, where I can place my resume.
Thanks a lot.
Irina

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Urmila in Toronto, Ontario

82 months ago

Rafi in Toronto, Ontario said: I Guess I made this question for first time but thank you so much for your reply.I am working for a CRO right now. But not as a CRA I want to have monitoring experience can you sujjest me what to do.

Sorry about that Rafi,
Guess I got confused with someone else.Anyways which CRO are Hyou working with and for how long?have you already joined the course online.I think you were interested in joining just as Irina has joined.

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Maria Bruining

82 months ago

avnit in Surrey, British Columbia said: I would like to know if there are any CRA training schools in BC.

Hey Avnit,
Have you gotten any responses about Clinical Courses in BC? I have been looking for a course similar to the one offered at Humber but on the west coast and haven't had any luck.
Thanks!
Maria

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Nicole Doyle in Glenside, Pennsylvania

82 months ago

Hello:
I am looking for CRAs in Canada for two of my Pharmaceutical Industry Clients. If you have some Industry outside monitoring experience please contact me. Great Salary, Benefits etc.

Also, if you know someone who has the experience who may be interested please have them forward their most update Resume
and contact me ASAP.
Thanks for all your help, I look forward to speaking with you soon!!

Nicole Doyle
Global Client Liaison/ Executive Staffing Specialist
ndoyle@recruitech.com
Ph# 1-866-378-4782 x118

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avnit in Surrey, British Columbia

82 months ago

Maria Bruining said: Hey Avnit,
Have you gotten any responses about Clinical Courses in BC? I have been looking for a course similar to the one offered at Humber but on the west coast and haven't had any luck.
Thanks!
Maria

Hi Maria,
no response yet. this is so strange that most people here are from Toronto side. anyways,I will contact Krieger.

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Urmila in Toronto, Ontario

82 months ago

Hi there Maria and Avnit,
I saw something on Child and Family Research Institute,BC. Try that site and see if it helps.
Yes many of us are from Toronto but that is not the purpose of this forum.
Kriger is a good option. Try and see and keep us posted.

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harman poonia in Brampton, Ontario

82 months ago

hi all

m dng online course at KRIGER , frm last 3 weeks m taking final exam of kriger , bt dnt knw somehow i m not getting 70 % . i guess i am prepared enough to score this much after all i have masters in biochemistry . so m not getting the point , i feel like its all programmed in site , that they guys want u to make 5 -6 or more attempts to clear that exam. if anyone has passed this kriger exam , let em knw the funda , . thx .bbye

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Pooja in Toronto, Ontario

82 months ago

Hi harman I am also taking the online course at kriger andi asked tthem they said some students complete the course in 3 weeks.I am still on topic 23... did u try answering all the questiosn ? how many topics did u do in a day ? did u fnish ur projects ?
thanx

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Urmila in Toronto, Ontario

82 months ago

Hi Pooja,
I think you misunderstood the minimum time taken should be 3 months not 3 weeks. What will you learn in 3 weeks. Do not rush.

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breddi

82 months ago

hi,

I passed this this exam in my second attempt. not programmed anything..u need to focus where u might have made mistake.

gud luck,
cheers..\
reddi

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harman poonia in Brampton, Ontario

82 months ago

breddi said: hi,

I passed this this exam in my second attempt. not programmed anything..u need to focus where u might have made mistake.

gud luck,
cheers..\
reddi

hi
did u finished ur projects b4 exam ?

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harman poonia in Brampton, Ontario

82 months ago

hi

wot 's this project kinda thing. m not getting it , can someone tell me details ? now m thinking like , it was not a gud idea to do online course at kriger.i really need help.

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Pooja in Toronto, Ontario

82 months ago

Hi harman

after completing all ur sessions and before atempting the final exam u shud do the projects.The projects 1- 4. I am sorry im not tehre yet otehrwise i wudve helped u

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Urmila in Toronto, Ontario

82 months ago

Hi ,
Have you passed the online exam?

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MG in Silver Spring, Maryland

82 months ago

harman poonia in Brampton, Ontario said: hi all

m dng online course at KRIGER , frm last 3 weeks m taking final exam of kriger , bt dnt knw somehow i m not getting 70 % . i guess i am prepared enough to score this much after all i have masters in biochemistry . so m not getting the point , i feel like its all programmed in site , that they guys want u to make 5 -6 or more attempts to clear that exam. if anyone has passed this kriger exam , let em knw the funda , . thx .bbye


Hi Harman, I also started this training about 3wks ago. Completion of the project before taking the exam is recommended, but not required. In fact, KRC says that the exam doesn't include the project and the Pharmacology part. You better know how true this is, since you attempted it. I didn't take the exam yet, but started the project. I sometimes get tempted to try it, but then I ask what if I fail. Well, I can attempt it more times, but wouldn't that affect the impression those guys will have on my preformance? Anyways, it is better to get prepared well before attempting it. After all, it is the knowledge, not passing the exam what matters most.

GOOD LUCK!

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harman poonia in Brampton, Ontario

82 months ago

MG in Silver Spring, Maryland said: Hi Harman, I also started this training about 3wks ago. Completion of the project before taking the exam is recommended, but not required. In fact, KRC says that the exam doesn't include the project and the Pharmacology part. You better know how true this is, since you attempted it. I didn't take the exam yet, but started the project. I sometimes get tempted to try it, but then I ask what if I fail. Well, I can attempt it more times, but wouldn't that affect the impression those guys will have on my preformance? Anyways, it is better to get prepared well before attempting it. After all, it is the knowledge, not passing the exam what matters most.

hi

u r dng projects ? gud , hey we need to go to some project site to do those 37 tasks? or this is in house CRA tasks? m so worried bout this course nd project work , for me its like wastage of money, i need to finish as early as possible bt m feeeling so dumb,
can u guide me ? could u plz give me notes of these projects.

GOOD LUCK!

harman

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ravi in Teaneck, New Jersey

82 months ago

you may join in aipt, USA at www.aiptnet.com for project
they heve wonderful projects.

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Urmila in Toronto, Ontario

82 months ago

Hi Harman and Pooja,

If you rush through any course it will be confusing. Why are you in such a rush? Are you already working in a biopharmaceutical industry?
CRA job needs mature and patient people not someone who just rushes....try to grasp what you are learning not just for the sake of exam.

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harman poonia in Brampton, Ontario

82 months ago

m not working , nd as such i dnt have any final plan to work as a CRA. bt as i have joined the course so somehow i have to finish it nd get diploma certificate , that's possible only if i clear exam , finish projects , submit article etc

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harman poonia in Brampton, Ontario

82 months ago

plz answer TRUE / FALSE of following questions

1. sponsor ( not investigator ) is required to maintain hard copies of IC forms.
2. auditing inspections allow verification of source documents including medical records, drug account,storage etc
3. study monitor is responsible for overseeing general health of all subjects.
4. FDA may review (i) protocol & SOP , frequency of visit
(ii) investigator log book
(iii) record of on site visit, date etc.
(iv) I & II
(v) II & III
(vi) I & III

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pooja in Toronto, Ontario

82 months ago

hi harman im almost in the same situationas you.i got interview call and im going to join the course at oxford because take onlins i think is waste of money.i just need my experinece papers.but i called and asked them and they said all qqestions hould be answeres and then u can attempt final exam.i finioshed all chapetrs.tommorrow i will attempt final exam.what are u finidng difficulty in ?

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breddi in Hamilton, Ontario

82 months ago

Hi Harman,

Here is my view about the answers.

1. sponsor ( not investigator ) is required to maintain hard copies of IC forms. -Yes

2. auditing inspections allow verification of source documents including medical records, drug account,storage etc- YES

3. study monitor is responsible for overseeing general health of all subjects.
No. Monitor is not resposible. but PI is responsible for overseeeing general health of all subjects

4. FDA may review (i) protocol & SOP , frequency of visit
(ii) investigator log book
(iii) record of on site visit, date etc.
(iv) I & II
(v) II & III
(vi) I & III

I guess FDA can review Protocol and SOP, frequency of vist. I am not sure investigator log book. I dont think they need it.

Any comments or suggestions would be appreciated.

Gud luck.
Reddy
Toronto

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breddi in Hamilton, Ontario

82 months ago

Hey Pooja,

How was the interview? is it ofr CRA or CRC? wat questions did they ask u? if you dont mind could you post them?

Thanks,
Reddy
Toronto

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harman poonia in Brampton, Ontario

82 months ago

hey breddi

thx a lot for answers.i m sure this way i would get better answers and would be able to clear exam . i m feeling gud now. nd hopeful too. god bless u . i guess u wont mind if i ask some more questions .thx once again.

i knw m being greedy, bt plz here r some more questions:

1. FDA may ask for recall of marketed drugs.
2. IRB is responsible for determining frequency of conti. review i. e. application to trial / site.
3. monitor should submit written report after each trial related communication.
4.new health fraud products with undetermined economic impact and limited health significance should result in a warning letter to promoter.
5. investigator is responsible for ensuring that a clinical investigation is conducted in full compliance with signed invetigator state and application regulations.
6. inspection reports are problemtic for trial since they reveal subjects 's identity.

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breddi

82 months ago

Hi,

1. FDA may ask for recall of marketed drugs.

Yes FDA can recall of marketed drugs if they receive any complaints form physicinas or from public. Thats the reason they keep an eye on post amrketed drugs.

2. IRB is responsible for determining frequency of conti. review i. e. application to trial / site.

IRB can't determine frequency of site visit or trial. But if the trial is complicated they might ask for trial reports frequently or review the trial. Usually they review every year. Investigator will submit trial report every year. Sponsor will determine how frequently their monitor visit the site. Subject's safety is primary concern for every one.

3. monitor should submit written report after each trial related communication.
Yes monitor should submit report on thier each visit about the trial.

4.new health fraud products with undetermined economic impact and limited health significance should result in a warning letter to promoter.

Iam not sure about the above question. I dont know the answer.

5. investigator is responsible for ensuring that a clinical investigation is conducted in full compliance with signed invetigator state and application regulations.

Yes investigator is responsible to conduct a trial in compliance with the protocol agreed to by the sponsorand regualtory authorities.

6. inspection reports are problemtic for trial since they reveal subjects 's identity.

It is not problematic. you can only use initials. u can use sub initials in other direcotry. u need not show them sub identity.

hops this help u.

cheers,
gudluck
Reddi

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harman poonia in Brampton, Ontario

82 months ago

hi reddi

thx for answers. i really appreciate it. i m sure these answers wud help me to get enough marks to pass this exam.

thx once again. nd i wud post more questions if in any case i find them difficult.

bye . take care.
thx onc eagain. gud luch to u too

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harman poonia in Brampton, Ontario

82 months ago

hey guys i have some more questions , plz do answer

1. TPD has specific function
(a) safety and efficacy of drugs , which are already on market
(b) quality of drugs prior to market approval
(c) quality of drugs , which are already on market
(d) safety and efficacy of drugs currently in clinical trials
(e) it has wide range of functions
2. appropriate feature for computerized system
(a) automatically enter data when field is bypassed
(b) altering system when data is not logical
(c) annonation system for patient diary should not be allowed
(d) security feature should prohibit unauthorized access , inspection , review
3. volunteer compensation , which one is true ?
(a) any compensation paid to subject ,who dont complete , should be repaid
(b) pre approval by IRB
(c) any payment should be considered as benefit for participating rather than incentive
(d) they are given large bonus
(e) volunteers dont receive any money
4. false acc. to FDA
(a) they reflect principles recognized by scientific community as desirable approach
(b) legal requirement for clinical research
(c) sponsor may develop own procedure
(d) FDA may make periodic changes to published regulations
(e) all
(f) none
5. preclinical stage is important
(a) determine drug metabolism
(b) determine toxicology
(c) determine pharmaco kinetics PK
(d) A & B
(e) B & C
(f) A,B,C
6. HIPAA purpose is
(a) insurance plan for subjects
(b) accounting system to reduce abuse of health care system
(c) international safety standard for conducting clinical trials
(d) to develop administration & financial transactions standard
(e) none
7. prestudy visit include confirmation EXCEPT
(a) IRB witten
(b) 1472
(c) signed protocol
(d) IC form
(e) financial disclosures
(f) none
8. definition of CRO acc. to FDA
(a) research company which hire employee on contract
(b) pharmaceutical company that outsource clinical trials to smaller company
(c) leg

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NARESH KUMAR GAMIDI in Hatfield, United Kingdom

82 months ago

I completed my bachelor's in pharmacy from andhra university and master's in pharmacology from university of hertfrodshire.i am very much interested in the field of clinical research.But i don't have any experience in clinical research.i started my entry by being a member of ICR(UK).I am writing the DIPLOMA certification examination in CLINICAL RESEARCH which is conducting by ICR on 22nd april in u.k and i prepared to attend seminars and workshops related to clinical research and (ICH-GCP guidelines,ethics and regulatory approvals etc) with in the next two months. AND i am going to review the articles on clinical research upto date.
As these are sufficient for my entry level in the clinical research espicially in u.k or i have to do any special course like CRA course which is offering by KRIGER.

AT any how i should get a job in clinical research with in AUGUST 2008 which is my target.
i am requesting all the clinical research professionals please help me by giving advise and information about my query.
and i am eagerly waiting for the chance to prove myself in my interested area i.e CLINICAL RESEARCH (FUTURE TREND FOR YOUNG TALENTED LIFE SCIENCE PROFESSIONALS)

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harman poonia in Brampton, Ontario

82 months ago

hey
there's 8th ques 's mis pasted. this is
8. definition of CRO acc. to FDA
(a) research company which hire employee on contract
(b) pharmaceutical company that outsource clinical trials to smaller company
(c) legal entity working with sponsor who assume one or more obligations of sponsor
(d) FDA doesn't have any regulation
(e) none
9. what statement all investigational drugs must bear as a label
(a) caution - new drug limited by FDA for investigational use
(b) drug may cause severe harm , not yet approved by FDA
(c) only for patient #
(d) patient name, investigator name , dose amount,regimen
(e) adverse events , contact # of medical monitor in emergency
(f) none
10. what actions must investigator take to make changes in protocol
(a) inform sponsor for regulatory change , obtain protocol, amendment if required
(b) inform IRB
(c) modify I C ,obtain IRB approval
(d) inform study patients obtain new IC
(e) all
(f) none
11. not appropriate characteristic of monitor
(a) qualified physician, nurse etc.
(b) not necessarily qualified to diagnose and treat investigational products
(c) 3 year experience as CRA
(d) GCP

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Urmila in Toronto, Ontario

82 months ago

HI NARESH,

If you are already getting certified in UK why do you want to do a course with Kriger? If you are thinking of CRA in UK -your present certification should meet the requirements.
All the best

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NARESH KUMAR GAMIDI in Hatfield, United Kingdom

82 months ago

Urmila in Toronto, Ontario said: HI NARESH,

If you are already getting certified in UK why do you want to do a course with Kriger? If you are thinking of CRA in UK -your present certification should meet the requirements.
All the best

THANK U Urmila for ur valuable answer.but the course content of ICR EXAM is different from KRIGER.IS THERE ANY OTHER ADVANTAGES IF I GO FOR KRIGER IN JOB PLACEMENT AFTER TRAINING, because i want to for best one which settles me in clinical research
suppose if i would have right now join in kriger (CRA COURSE) is it possible to get a job in u.k before august2008 (if i put all my efforts with commitment and dedication and try my level best)
please give me reply....
i am waiting for ur reply.....

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harman poonia in Brampton, Ontario

82 months ago

hey reddi

thx for those answers , u knw this time i got 69 % , means i need to correct only 1 answer now. hey plz whenevr u log on , do help , i hope from these 11 questions ( which i ahve posted on this site ) must be corrected nd m sure i wud score above 70 , this time.

thx again.
gud luck to all

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Hami in Brampton, Ontario

82 months ago

I am really very happy seeing that the forum is getting more professional day by day. It really seems good when people discussing professional issues, trying to help each others, sharing their experiences solving problems giving guidelines based on their experiences. These sort of activities are sign for the forum success. This really encourages to participate with the expectation that one can learn a lot by sparing some time for the forum. Good Luck forum and good luck every body.

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avnit in Surrey, British Columbia

82 months ago

Could someone please give me some information about Kriger online CRA program. (I am thinking about taking this course).

for the online course, do I just print out the assignments (or final exam) and then submit the completed assignments (or exam)by email.

do they give few chances to do the Final Exam? (I mean if marks are low first time, do they give second chance to do the exam)

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Urmila in Toronto, Ontario

82 months ago

Avnit,
The online is totally online.You don't have to print anything.Everything is by email. They give you chances till you succeed. Let us know when you join- it covers a good deal for CRA. BEST OF LUCK

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harman poonia in Brampton, Ontario

82 months ago

hi avnit

there 's some demo option on kriger site , check out dat. nd yeah it includes bout 50 units nd 4 projects nd 1 article submission. so go for dat.

gud luck

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avnit in Surrey, British Columbia

82 months ago

Hi Harman and Urmila,

Thank you to both of you for your helpful comments. It really helped me. I will let you know when I join the course and as well as keep everyone posted about the course and my progress. and I hope this will help other people who will join this course in future.

Thanks

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nirmalthapa in Walpole, Massachusetts

82 months ago

Hi,I have just completed reading parts for CRA which is interesting from Kriger .So I would want to finished project parts also but when I was preparing about project ,I feel lazy myself so I want to write my exam first,

so My question is can I able to appear for exam without projects ,and can I be able to get certificate without projects.

and I want somebody who can help him in my projects.
but kriger is best for online CRA guys ,

I would appreciate for your help.

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kelly in Brampton, Ontario

82 months ago

tes in Waterloo, Ontario said: hi kelly, what would you say the average salary is for a cra just starting out?

Depends if you start in the hospital or pharma company setting or CRO company. Of course you start on the lower end. In hospitals can start high 30s - low 40's and move up. In a pharma company start low 50's.

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kelly in Brampton, Ontario

82 months ago

Irina in Toronto, Ontario said: Hi Kelly, Thanks for information.I have hesitated to take Humber, Seneca Coleges or Kriger Center. Do you know about Data Clinical Manegment course in Humber.
Best regards, Irina

No never heard of the data mngt course, dont be hesitant about the CR program at humber, its great and i know lots of others who took it after me and all still in the field with great jobs.

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Nirmal thapa in Boston, Massachusetts

82 months ago

hi, harman poonia in Brampton, Ontario
,Can you pleaase give me your email address

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Naresh kumar Gamidi in Hatfield, United Kingdom

82 months ago

MY mail id is gamnash@gmail.com

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