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Video instructions and help with filling out and completing Clia regulations
Hey everyone again welcome back to D clinical trials guru.com again that website if you don't know by now is the clinical trials guru calm these questions keep on coming and I'm getting to you guys as quickly as possible I've been getting a lot lately this one is from someone out in India and he's interested he's in college apparently he's about to be finished and he wants to enter clinical research but he wants to do it from a regulatory affairs standpoint and so some of the things you'll be doing some of your tasks first of all it depends on whether you'll be working at a research clinic a CRO a sponsor so it sounds like you're either gonna be at a clinic or a CRO and let me just tell you some of the things you'll be doing at a research clinic are completing the regulatory tasks and regulatory documents for the studies that your clinic will begin so you'll be doing everything from the 1572 forms to the IRB questionnaires financial disclosure forms you'll be helping out with the informed consents you'll be helping out with different rater trainings perhaps so you'll be in charge of maintaining all these documents furthermore you may also be in charge of helping your clinic out with SOPs and keeping a log of the delegation of duties logs for every study seeing who is doing what for which protocols which research member will be performing what tasks and you'll be doing this for every study so I had a clinic where there is 20 or more studies you'll be very busy and all these things have to be maintained people's licenses have to be maintained and of course every year you have to renew it you'll also be in charge of making sure that your staff members are getting their DCP trainings and things like that there's a lot you'll be doing salary wise this is anywhere from a starting starting entry probably $36,000 u.s. dollars if you're working at a us clinic you can eventually get more there's some regulatory people that get 7080 I've even heard a hundred thousand a year but you'll definitely be starting out well thirty six thousand and if you work in a CRO kind of the same thing I mean you'll just be submitting these things to the sites and to the sponsor and to the FDA as well but same forms 1572 IRB forms consent forms medical licenses the financial disclosure forms the electronic medical records forms I believe it's form 22 electronic data capture it means that the computer systems that you're keeping that electronic records are compliant with the FDA and with HIPAA so look into that so it really depends where you want to work for but a salary wise you'll be starting out at probably thirty six thousand and I say that because I frequently see job postings on LinkedIn and I get approached by people.