CRA Training resources

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.
cme.cancer.gov/c01/nih_intro_01.htm

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.
cme.cancer.gov/c01/nih_intro_01.htm

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.

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

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.

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.

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!

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.

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

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

Sarah, congratulations for your USMLE.

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

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, 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

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.

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!

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

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.

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?

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.

Cynthia in Somerset, New Jersey said: 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

I am currently attending American Scitech Institute located in Piscataway, NJ. The program consists of 6 months of training and 6 months of a PAID internship. Following the internship you have the opportunity to be hired by our affiliated CRO - American Scitech International eCRO. If you choose you can also be placed in another CRO through the placement service. The six months of training is considered expereince therefore if you choose to leave after the training you will have six months of experience if you stay for the internship than you will have a year of expereince. To learn more about the school visit craschool.com. For anyone looking to FINALLY get their foot in the door but can't because they have no experience this is the program you need to be apart. It is the quickest way to get experience. This program is better than an online course because it is considered experience. You are given the ability to obtain the fundamental and practical knowledge you need in order to be a successful CRA. Good luck with everything if you would like to know more or attend a seminar please email me at msantoro@americanscitech.com.

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

Hi Sarah:
I took the CRA cert. course at MSU. It was incerdibly thorough and very interresting as well. You can contact Mark Bitman and he'll sign you into the demo so you can see the course before committing to it. I looked at others, but decided to go with a known university for my resume. Here's the link: nursing.msu.edu/cracrc.aspx

Good Luck!

I am currently attending American Scitech Institute located in Piscataway, NJ. The program consists of 6 months of training and 6 months of a PAID internship. Following the internship you have the opportunity to be hired by our affiliated CRO - American Scitech International eCRO. If you choose you can also be placed in another CRO through the placement service.

Has anyone attended the practical Clinical Internships ($800) for students at Kriger? Is this a scam?

Miranda Wong in New York, New York said: Has anyone attended the practical Clinical Internships ($800) for students at Kriger? Is this a scam?

there will be no real time experience. no interaction with the team.

Do you mean that experience is not comprobable?

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.

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

Thank you

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

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

Hi Jazz-

At American Scitech we offer training, paid internship and employment. If you would like more details please feel free to call at 732-981-8686 or email at msantoro@americanscitech.com. Thank you

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.

thank you for the information

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!!?

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.

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

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.

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.

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.

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

Olga in Hackensack, New Jersey said: Does anyone know the CRA on hand program in American Inst of Pharmaceutical Technology? What is the quality?
Thank you.

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

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.