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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.
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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.
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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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