This is wonderful to hear! 🙏🏼 ...I’m so glad it helped you and you bring up a great point of how this can be applied to a CRC position. That’s because the CRC and CRA positions greatly overlap, which I discuss in my newest video titled transitioning from CRC to CRA. I wish you continued success in your career!
Hello Eric, that was a precise explanation of the role of CRA. Thank you very much. Just two questions, in the regulatory/IRB experience, does one needs to explain the therapeutics of the study participated in? Second, how the CRA managed to tackle the EC/RA Queries or in case the non-approval?
You do not need to explain in detail your therapeutic experience but as I always say, answer through example. If the hiring manager is looking for someone with a specific therapeutic experience then you will need to explain what experience should have in those therapeutic areas so that you can highlight that experience....I haven’t seen questions regarding situations where there is non approval. They typically don’t get that detailed. They may ask tricky situational type questions but even those are typically a little broad. If you don’t get approval, then you will need to analyze why that occurred, make the appropriate changes with management and resubmit.
what bachelor degree related to health science can I start with to entry this path of career? is it only for professions like nursing,doctor or people with bachelor of public health can also start such certification?
They usually require you to have a bachelors of science but as long as you have a bachelors degree of some sort you should be fine. It’s more about your experience in the industry that will help you land jobs. I can also help you with job training and interview prep etc through my consulting firm, www.lombereindustries.com
Also, I thought the question about the physician was a trick question because a PI doesn't technically have to be a licensed physician per federal regulations, a sub I can be a physician. Although this situation is uncommon, I have seen this.
Almost every single sponsor will require the PI’s and Sub-I’s to be licensed. If a site tries to push a non licensed physician they will have an incredibly difficult time and will likely fail.
Hi Can I please ask you - How do you best answer this: -What do you do if you are monitoring a study and despite repeated efforts cannot get in touch with the PI? - my ans: Document the communication attempts that have been made (email telephone letter), what the site says (CRC; PM) regarding the PI’s availability, contact the CO-I, sub-I or Medical Monitor to get a solution to your need. Is there anything else? 🙏
Hi! Thank you for the Video, I have a certificate of CRC and a a year experience of Clinical research from Africa. What are my chances of getting a CRC job in developed Countries like USA, UK etc
You should watch my work visa video. I discuss this topic. However, I am not an expert in immigration laws, so I would recommend that you really do your research on how to work in other countries. I would say your experience and certifications would be fine to get a job anywhere in clinical research but what's important is getting your green card here in the USA for example. Green cards and efforts to become a citizen are what employers will be looking for if they are considering hiring someone from another country.
Thank you so much! This video was very helpful! I have worked as a Clinical Coordinator for 3+ years. Please advise on how to obtain an entry level CRA job since many positions seem to require a minimum of 1 year CRA experience.
Sandra Jacob hi Sandra, the best way to do it is to match ur resume to that of a CRA. Look up job descriptions of CRAs on linked in and tailor your responsibilities as a CRC to match the CRA duties. You have worked with monitors on every clinical trial you have ever conducted and because of that, you know what CRAs do and can speak on knowing the role by showing how your CRC role over laps with the CRA role. This will tell the hiring managers that although you have never held a CRA title, you still know how to perform the job because of your experience. Next, you want to apply to sponsors that are known for hiring fairly green people. Edwards life sciences is a company that does this. Applying to places like this will help improve your chances.
I'm a pharma gradute sir in a cro company who will became CEO of that company in along term process as it self clinical research organisation I think CRA or clinical trail manger will be as main thing for cro or else any other domine will become CEO of cro please????
Could you please tell me what are some possible differences between CRAs working for CRO and those who work for a sponsor? Thank you so much in advance!
It’s the same job however CRO’s are more likely to have you work on multiple protocols from different sponsors. You also will be taking direction from the sponsors in additions to your manager on the CRO level. CRO’s may also use you for monitoring while on the sponsor level the monitoring is usually dedicated to the field monitors which is separate from the in house CRA’s
Hi, Im interested in a direct to pharma or transition to consulting and leave the CRO world behind. Any tips you recommend for consulting services as a CRA? I have a a total of 15 years of clinical research experience, 8 years strictly oncology monitoring. I feel I have more than what it takes to be a consultant but need some guidance and have not been able to connect with any consultants lately. Thanks man!
Well you have To leverage your strengths and form a business model. You can potentially creat a monitoring company and try to get sponsors as clients but you will need to have the ability to do this.
@@ErikLombere thanks for your reply. I do not necessarily want to create a company, just get into consulting. Ive met a few CRAs a few years back who were independent consultants and this was very appealing to me. That’s what I’m trying to get into.
@@vbuen323 when a company hires a consultant, it’s similar to them hiring you as a contractor. You don’t receive any benefits. Plenty of recruiters have these contractor consulting positions but I don’t recommend them. I would advise for you to get hired as an employee.
Hi thank you so much for this information. However, if want to pursue my career in CRA what is the position I should join in? Also I'm currently working in clinical data management team so I already have some idea of how the trials are been conducted. Any tips on where to start ?
It’s great that you are starting with some experience. This will make it much easier for you but because you do not have direct clinical research experience, you may still have some push back from recruiters. I would recommend applying to CTA jobs and then apply to CRA jobs after you gain the CTA experience. I can provide consultation calls if you would like more 1 on 1 help. You can email me or DM me on IG.
Hi thank you for this video. I have a question about informed consent, would a patient need to sign off on an ICF prior to being screened and blood samples collected for the study?
Thanks, helpful , so may I ask is regulatory submission one of the responsibilities of a CRA as a single person? For selecting and activating sites and recruiting I mean? Or is it sponsors duty?
That’s a great question. Usually there is a team on the sponsor level and the responsibilities will be dispersed amongst the team. However, as the CRA, you are expected to do any and all of these duties as needed. Small and large sponsors will each manage this differently, so it is good to have experience in all of these fields to be better prepared. Also, things change over time within companies and you can find your responsibilities change over time as well.
@@bigsnacks6485 they perform the submission but the sponsors need to track these submissions for each site and ensure that each site is up to date on all IRB approvals.
