ClinEssentials

Let’s take a Poll! How often do you file emails to the eTMF? A - Once a month B - Once a week C - Immediately D - Per the company SOP E - Other Read more about the TMF here → https://lnkd.in/eH3EuW-E

Do you see clinical trial management as a future career? Did you know there are 4 roles in Clinical Research that transition to Clinical Trial Managers most often? These 4 roles provide the most seamless transition to the CTM role. By planning your career journey to include one of these roles, you can fast-track your path to CTM! Check out our FREE guide, How to Transition to a Clinical Trial Manager, to assist in planning your career path and goals. Click here for the FREE download: https://lnkd.in/ghZeaDB5

Trial Master File (TMF) and Investigator Site File (ISF) are often confused for one another - or are used interchangeably - but they are not the same. Every study has a TMF, which is a compilation of essential documents that together tell the whole story of the clinical trial. The TMF, which should be inspection-ready at all times, is important because it shows compliance, demonstrates successful study management, and showcases quality, uncompromised data. Reconciliation of the TMF is the responsibility of the Sponsor and CRO. Every participating research site also receives an Investigator Site File (ISF), which is also called the Regulatory Binder and is the responsibility of the site to maintain. The ISF contains essential documents such as the protocol, Investigator Brochure, protocol signature page, CVs of team members, IRB approval letter and patient consent forms, delegation of authority log, training logs and more. You can read more about the TMF and the ISF in this blog post: https://lnkd.in/eH3EuW-E

Here’s a hint that many aspiring research professionals don’t know - and it often costs them a lot of time spent on a job search. When you are looking for a job in Clinical Research, applying is not the first thing you should do. In fact, there are six steps you should take before you apply for jobs. We give you these six steps - and many more tips, facts, and resources - in the Introduction to Clinical Research Guidebook. You can buy it here: https://lnkd.in/eEsUZfc6 The information in this Guidebook will kick-start your Clinical Research career journey. You’ll be equipped with the must-know info about the industry, and the best, trusted websites and resources to use throughout your career. Here’s another hint: this Guidebook will get you started on a long, meaningful, successful career in Clinical Research. Buy the Guidebook now! https://lnkd.in/eEsUZfc6

Tiffany Ashton, MAS, CCRA, Director of Operations for ClinEssentials, sat down with Nicole M. Palmer, MS for her TMF Daily podcast. During the episode, called Trial Master File Career Paths, Tiffany and Nicole discuss many Clinical Research roles, including CRC, CTA, CRA, CTM and PM. Watch it here: https://lnkd.in/e4pTfCFX You’ll hear about these topics and much more: - How to learn the Investigator Site File as a CRC - The value of the CTA role - Importance of collaboration for the CRA and study team - The CTM role: helpful soft skills, advice for people who want to become CTMs, and more - Difference between a CTM and a PM This is a beneficial listen for research professionals at any stage in your career. https://lnkd.in/e4pTfCFX

Summer fun has begun! But not if you’re overloaded with work… Boost your efficiency with time-saving tools from ClinEssentials - and spend less time working and more time “summering!” CRA Audit Notes are proven to increase efficiency when monitoring by up to 30%! Think of all the extra time you’ll have for walks, the pool, gardening, BBQs, etc. CRA Audit Notes (and [almost] ALL of the items in the ClinEssentials Shop) are 50% OFF - but the sale ends tomorrow (June 2, 2024 at 11:59 pm PST).* Shop Now: https://lnkd.in/diw8qZ6Z Limited quantities are still available! *The CTM Training Course is not included in this sale.

The road map for Clinical Research jobs is not always clear. Many aspiring research professionals find themselves driving in circles, and getting nowhere fast. To help you get off the slow and windy road and veer on a fast and straight path, ClinEssentials created the Introduction to Clinical Research Guidebook. The Guidebook is your clear road map that will lead you to Clinical Research career success. Lift the fog and buy the Guidebook here: https://lnkd.in/eEsUZfc6 Aspiring Clinical Research Professional, Javier G., says: “The Introduction to Clinical Research Guidebook takes you by the hand and walks you through not only how to enter the clinical research industry but to progress towards senior roles. I feel more confident in how I need to approach my strategy in becoming a clinical research professional!” Your clear road map to Clinical Research is waiting! Buy it now: https://lnkd.in/eEsUZfc6

SPRING CLEANING SALE at CLINESSENTIALS! If you’re running low, ran out, or have been wanting to try time-saving tools from ClinEssentials, this is the best time to restock and stock up! Nearly every item in the ClinE Online Shop is 50% off!* Shop Now: https://lnkd.in/diw8qZ6Z Items included are: CRA Audit Notes, Action Item Pads, Visit To Do Lists, eBooks, Bundles, Digital Downloads, etc. The sale ends June 2, 2024 - or until items sell out. Hurry and Buy Now - our items sell out FAST at sale time! https://lnkd.in/diw8qZ6Z *The CTM Training Course is not included in the sale.

The ClinEssentials Spring Cleaning 50% Off Sale is still going on, but inventory is low! Shop the ClinEssentials Sale here: https://lnkd.in/diw8qZ6Z Procrastinators Beware: If you have been meaning to place an order and haven’t gotten around to it yet, you may want to move this higher on your To Do List. Almost every item in the ClinEssentials Shop is 50% off. Yes - even the Bundles! (The CTM Training Course is not included in this sale). Don’t delay! Shop today! Shop the ClinEssentials Sale here: https://lnkd.in/diw8qZ6Z

Did you know that we add to the Freebie Library on the ClinEssentials website each month? That means 12 new freebies will be available in 2024 alone! One of our most frequently downloaded freebies is the Monitoring Visit Checklist. If you are a CRA and you aren’t using this, you are missing out! This checklist helps you stay on track. Get the Monitoring Visit Checklist - and all of our other freebies - right here: https://lnkd.in/g2wEZpjd Download them all simultaneously, or just select the ones you want. Remember to check back each month!