NEW MASTERCLASS
I will review the drug development process for bringing a new pharmaceutical drug to market, and the role of a Clinical Research Associate. I will also review ICH/GCPs from a CRA perspective, your obligations as a clinical research monitor, and what is the best way to get your start in this role.
I will review the 4 types of monitoring visits, as well as, the purpose and tasks for each. You will also receive a visit checklist for each visit type for a future resource. Time management can be a struggle for many CRAs. I will review tips in managing timely deliverables between visits. I want you to succeed!!
I will review step-by-step how to complete on-site tasks such as, ISF review, ICF review, source document review/source document verification/risk based monitoring, query writing, IP accountability, etc. You will receive a QC guide to use as a resource for future review of Essential Documents. I will also review monitoring responsibilities between visits such as, trip report completion, TMF submission, and administrative deliverables.
In my career as a Clinical Operations Manager, I conducted many interviews. In this course, you will go from feeling confused on how to begin your CRA journey to feeling confident as you learn more about the role, gain fundamental knowledge, and how to get your foot in the door. With this foundation you will experience more confidence while interviewing, and what it means to be a good, quality monitor. Confidence in combination with that foundational knowledge, can help YOU standout over someone else with a similar background.
My journey began as an In-House CRA, to a road warrior/On-Site Monitor for 14+ years, received ACRP certification, and transitioned to a Clinical Operations Manager focusing on training new CRAs for 3 years. I have knowledge and experience from my career that can help you.
I know from experience what it is to be a new CRA, an overwhelmed seasoned CRA, a star performer, and cramming for the ACRP CCRA exam.
As a Clinical Operations Manager, I know what the expectations are of a CRA from a managerial perspective, and the common struggles that a CRA faces. As a trainer of new CRAs, I know from experience what foundational training is needed to succeed as a quality monitor.
*The five step-by-step training modules, PDF checklists/workbook resources, five 1:1 coaching calls, and CV review/feedback total a value of $397. You don't want to miss this!!