Research Regulatory Specialist II - Lexington

Only for registered members Lexington, United States

6 days ago

Default job background
$25.01 - $41.25 (USD)

Job summary

The Markey Cancer Center, Clinical Research Organization, is recruiting for a Research Regulatory Specialist II ( RRS II – Regulatory).
This position accepts research responsibility with guidance from the Principal Investigator(s) and the Research Admin & Operations Director.

The RRS II-Regulatory is responsible for obtaining and coordinating data and other required information needed to fulfill all the regulatory requirements for protocols, including IRB submissions, informed consents, safety reports,
and adverse event forms.

Maintain all regulatory records as per FDA regulations. Maintain trial management databases required for each protocol. Ensure accuracy and completeness of regulatory records and verify ongoing studies are completed in accordance with applicable FDA regulations. Will participate in site evaluation,
initiation,
monitoring
and termination visits.
This position has a Hybrid work arrangement.
Please note:
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