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Operational Support
Operational Support

Our Clinical Operations Associates (COAs) fill a crucial supportive role to all members of the team. COAs work to streamline the process of managing a clinical trial. A primary function of this role is to act as a central point through which virtually all clinical documentation is channeled. As documents are received, they are logged into a tracking system, scanned, and either filed in our in-house Trial Master File or forwarded to the client using a transmittal system. We have developed a proprietary process of managing regulatory documentation that provides our CRAs with a tool to ensure that site regulatory files mirror the Trial Master File, with a minimal amount of administration. This means that the site regulatory file is kept current, at a lower cost than organizations using more conventional processes.

 
COAs also compile regulatory and enrollment data from investigative sites, which can then be posted to a secure, client-specific web site. Clients requesting this value-added service can access a web portal at their convenience, with a username and password.
 
The Director of Clinical Operations provides high-level quality control by managing client expectations, employee workloads, compliance with SOPs and policies, employee performance evaluations, and providing guidance and support to the team. This supervision creates an environment of consistency and high-quality work for our clients.
 

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