Hi Daniela, a site can start implementing the changes once they have received IRB approval on the protocol amendment, a revised ICF (if applicable) and there is documented training that the site staff have reviewed the protocol updates. You may also have to update the source documents too depending on if new procedures are added. All of these should be done or in place prior to implementing.

@@ClinEssentials thank you or the response. I am wondering, if the protocol amendment affects the site budget, the budget must be finalized prior enrolling subjects in this new protocol?

​ @DanielaMartinez-nn3tu Yes, there may be impact to the site budget as well if procedures are added in the PA (so the budget would increase) or procedures removed (the budget would decrease). It would be best to have this confirmed prior to implementing the PA.

You can order them here: clinessentials.com/shop/

Thank you! We are happy to share.

That is good experience to start with at the site level working as a Research Assistant or a Clinical Research Coordinator. Do set yourself up for success by taking Good Clinical Practice and a Medical Terminology class at minimum so you can hit the ground running.

@@ClinEssentials I have both GDP and took med term in college.

Hi Jen, feel free to reach out to Tiffany on LinkedIn to further discuss. This question would be better suited in a 1:1 conversation. www.linkedin.com/in/ tiffany-ashton-clinessentials

We have career services were we can discuss specific questions or concerns. You can learn more here: clinessentials.com/career-services/

We ship internationally. You would proceed to: clinessentials.com/shop/ and order and add your Ex-US address upon check-out.

You can purchase them within our shop: clinessentials.com/shop/ and we ship internationally as well.

Hi Angela, thank you for your question. Staffing resources is a HUGE challenge for all roles in the industry currently. We suggest you prioritize your studies based on due dates and timelines. For instance, if you have a study that has QIs to be addressed by 09-Sep, but the other QIs are due 30-Sep, prioritize those due 09-Sep first. However, between now and 30-Sep, set some time aside (block time in your calendar) to work on the other studies so you can work at a steady pace. Another option is to speak with your manager for a potential temporary helper to help you address the QIs. Do not be afraid to ask for assistance. If you do not ask, they will not know you are overwhelmed with the new studies and need help. We hope these tips help!

Wonderful tips. You are a pro. Filling up the dead space is a must! Love the tide pen idea.

A mouse is a must and also spare batteries for it too. We would add a few snacks too - granola bars, nuts, dried fruit in a pinch when you cannot get away for lunch.

Many of the major CROs are global - ICON, IQVIA, LabCorp just to name a few. Review their website for openings under careers to see what they have available.

There is a CRA Starter bundle you can try that has 6 of the most common audit notes for your use. Here is the link: clinessentials.com/product/cra-starter-bundle/