What is a Clinical Operations Toolkit?

Combining ability, character, and training into a toolkit allows clinical research professionals to problem-solve on the fly

Combining ability, character, and training into a toolkit allows clinical research professionals to problem-solve on the fly and provide quality support for challenging and complex studies.  Administrative skills, interpersonal techniques, intellect, personality, and technical skills all improve with depth of experience.  A little humility helps, too.  As with any individual tool or group of gizmos, using something for a job successfully once doesn't guarantee you will be able to apply it the same way again to achieve future success; as much as possible, we are all well advised to tidy up the toolkit along the way.

I am currently a Clinical Program Manager at a small specialty pharmaceutical company and my primary focus is clinical trial management. I internally interface with medical directors, regulatory affairs, clinical compliance and supply, and clinical trial finance.  My team manages many outsourced partners including Contract Research Organizations (CROs), core lab vendors, subject recruitment vendors, Data Management and bio-statistical vendors, and other clinical trial support partnerships.  I am a liaison for principal investigators, clinical site staff, CRO staff, and our regional monitors on global trials. I’m accountable for project budgets, focused on quality deliverables, and committed to adherence to all corporate timelines.  At work, I strive to exercise good judgment when communicating with others to resolve potential conflict and promote teamwork.  I spend most of my time developing metrics for evaluating on-site clinical monitoring processes, remote monitoring of protocol conduct, measuring engagement in clinical trials, data review and analysis during and after a trial, and initiating quality improvement strategies as needed.

I also value unplugging from work.  When the blackberry is off, I am traveling the world, practicing amateur photography, and teaching myself to cook.  I have two little Yorkshire Terriers that love to go on walks at the beach and a beautiful home in San Francisco where I relax and unwind with my loving husband and partner of 10 years.

As I grow my career in clinical trials, I invite you to follow along with this blog.  I’d love encouragement as I develop my clinical operations toolkit and hone my clinical trial instincts. I’d also be delighted to hear about your experiences and insights. Please contact me via the comments form below or email.

I’d also appreciate if you follow me on the Clinical Operations Toolkit Facebook page.

Other content you may like from the Lead CRA

Career Tips for Clinical Research Associates July 2011
Great Qualities in a Clinical Trial Assistant February 2011
How I got Here January 2009

About The Author

Nadia

Nadia Bracken, lead contributor to the Lead CRA blog and the ClinOps Toolkit blog, is a Clinical Program Manager in the San Francisco Bay Area.