Let's Get Clinical, Tips From The CRA Helper

#011 - Learning the common audit findings is so beneficial for a CRA.  It can serve as a reminder of what to look for and serves as a helpful tool in order to prevent them.  This week, I discuss issues associated with missing/incomplete essential documentation. This documentation is so important and is a requirement per GCPs as they permit evaluation of the conduct of a study and the quality of the data produced. Remember, in addition to subject safety, one of our primary obligations as a CRA is to ensure data integrity and quality. Essential documents demonstrate the compliance of the investigator, sponsor, and monitor with the standards of GCP and with all applicable regulatory requirements. The Investigator Site File, aka Regulatory Binder, and the TMF, should be audit ready at all times. In this particular episode I focus on the Delegation of Authority Log and training documentation.  Join me, as I share some helpful tips for successful Reg Binder review.

#010 - Learning the common audit findings is so beneficial for a CRA.  It can serve as a reminder of what to look for and serves as a helpful tool in order to prevent them.  This week, I discuss issues associated with Investigational Product (IP) accountability. As CRAs we have a lot of responsibility when it comes to IP, which remember, is drug that has not been approved by the FDA. We want to ensure it is secure, controlled, provided to only eligible subjects at the protocol specified doses, and stored appropriately in order to ensure it is stable, safe, and effective for subject use.  This is my favorite area, and I could go on and on regarding study drug LOL. Join me, as I share some experiences from my monitoring journey, as well as, tips for successful IP review.

#009 - Learning the common audit findings is so beneficial for a CRA.  It can serve as a reminder of what to look for and serves as a helpful tool in order to prevent them.  This week, I discuss issues associated with AE review and reporting. As CRAs our two most important obligations are subject safety and data integrity. It is extremely important that we monitor this closely, and ensure that data is reliable as this affects regulatory decision making and approvals.  We need to ensure that trial data is of high quality as these are patients’ lives. Join me, as I share some experiences from my monitoring journey, as well as, tips for successful AE review.

#008 - Learning the common audit findings is so beneficial for a CRA.  It can serve as a reminder of what to look for and serves as a helpful tool in order to prevent them.  This week, I am discussing the importance of complete source documentation and verification of subject eligibility. A subject that is randomized to study drug, and not truly eligible for the study, can risk a subject’s safety and the efficacy data of a trial. Join me, as I share some experiences from my own monitoring journey, as well as, helpful tips for CRA review.

#007 - Learning the common audit findings is so beneficial for a CRA.  It can serve as a reminder of what to look for and serves as a helpful tool in order to prevent them.  This week, I am discussing common audit findings regarding informed consent.  I will touch on issues relating to the form itself (the ICF), the consent process, and HIPAA. Join me, as I share some experiences from my monitoring journey, as well as, helpful tips for CRA review.

#006 – Working as a home-based CRA sounds like a dream, right?  Working from home is definitely a privilege but be careful not to stumble into any pitfalls.  Some can get distracted, non-productive, and feel isolated when working remotely.  In this episode I will discuss tips to work successfully at home and share some stories from my own home-based experience LOL.  Being a remote CRA is such a blessing, and to be successful, it’s all about boundaries, being accountable, and discipline. Join me, and let’s talk about the perks from working at home!

#005 - Are you familiar with Monitoring Visit Reports, and what to include?  If not, I'm here to help! In this episode, I discuss why MVRs are required, and what they should contain.  I also review how to document issues, and the importance of corrective/preventative actions. I discuss what to document in regard to review, and the metric of MVR TAT - Monitoring Visit Report Turnaround Time. I want to help you achieve quality visit reports and to be successful in all that you do!

#004  - As a Clinical Research Associate, travel plays a big part in your career.  I spent 14 years, of my 18+ year journey, as a road warrior, and want to help you.  In this episode I will discuss recommendations regarding packing, airport security, TSA regulations, tips for smoother travel, and safety. I will also share funny stories from my experience to guide you as well. Join me, and I will give you tips for successful travel!

#002 - This episode focuses on important deliverables that a Clinical Research Associate must manage between monitoring visits, why it is required to be on-time, and how important it is for a CRA to possess skills such as, prioritization, planning, multi-tasking, and organization. Time and time again, I have seen CRAs struggle in the area of time management. This can be overwhelming, lead to burn-out, affect performance reviews, and even result in a PIP (Performance Improvement Plan). Join me, I want to ensure you are set up for success right from the start!!

#003 - As a Clinical Research Associate, travel plays a big part in your career.  I spent 14 years, of my 18+ year journey, as a road warrior, and want to help you.  In this episode I will discuss monitoring visit intervals in the Clinical Monitoring Plan, tips in scheduling visits on the earlier side of the window, how a CRA schedules travel, helpful tips, safety, and the importance of a company Travel and Expense Policy. Join me, and I will give you tips for successful travel!