Kate Mandall

Can what has worked in the past still be utilized in today’s industry? If the answer is no, the best option is to branch out and use innovative tools. Change is good and necessary to be competitive in today’s market.

A day in my life at Clinipace

Hot cup of green tea, check emails, brainstorm, revise to-do list, work on projects, smile and repeat.

My “a-ha!” moment

I was on-site monitoring a lung transplant trial and a study patient was in the clinic for his follow-up visit.  The patient told the principal investigator (PI) how great he felt and how happy he was to be enrolled in the research study. We got to meet the patient and he was so thankful for the study drug and the team.  Not only was it great to see a study patient healthy and happy, but he also gave me a continuous supply of inspiration.  It’s not everyday you get to see the personal effects your dedication has on patients.  I think about that day often.  It reminds me how much our work touches the lives of others.

The most important consideration a client should take when undertaking a clinical research project

Most CRAs have a wealth of knowledge relating to numerous indications.  It is impossible for a CRA to be an expert on all indications in which they have worked, for their responsibilities and time spent on each study will vary from project to project.  Most sponsors require CRAs to have extensive experience with their study disease state.  It is very hard to find a CRA, who is available for participation and who has extensive experience for the study indication.  For every trial they have worked on, there was one sponsor who allowed them the chance to monitor a new therapeutic area.  We all have to start somewhere!  With that said, length of time in industry, previous relevant roles/responsibilities and ambition are key qualities which should be reviewed.  Once these qualities have been accounted for, look for the personal traits needed to build relationships with study site staff.  An all around quality CRA should have all of the above characteristics as well as determination and a desire to learn and grow.

One of the biggest misconceptions I run up against in my daily duties is

Although having big name sites on your roster looks good on paper, it’s sometimes better to go with the smaller fish.  If your protocol does not require technology that only a large hospital might have, try reaching out to smaller practices; they’re normally more willing and able to go the extra mile when working on studies.  Some larger sites have various levels of contract review and regulatory approvals that can stall study start-up.   Once you’re over that hump, it’s common for the coordinators to be extremely busy and face-time with big name PI’s can be rare.  As always, weigh your options and go with the sites that meet your timeline without compromising data quality.

Professional organizations

Association of Clinical Research Professionals, The Society of Clinical Research Associates