Creating a culture of compliance

Edye T. Edens (edye.edens@firstclasssolutions.com) is a Senior Research Compliance Consultant with First Class Solutions, Inc. in Maryland Heights, MO.

In my first decade as an attorney, I’ve had the unique privilege of being the “first” to hold several compliance-related positions, and even aided in the creation of an office dedicated to clinical research compliance at a major academic medical center. For me, these positions were a blessing and, while overwhelming at times, provided the opportunity to mold the roles to fit my strengths and the needs of the organization. Whether you’re being handed the keys to your dream job or taking over a position in a crunch, bringing a compliance plan that includes auditing and monitoring for a successful launch is no doubt daunting. I’m taking the opportunity to document my successes and failures below, so you can avoid any shortcomings and find success in your compliance efforts.

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