Specialist I, Regulatory - Hyderabad, Telangana

Only for registered members Hyderabad, Telangana, India

1 week ago

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Job summary

The Regulatory Specialist I prepares and maintains complete and accurate regulatory documents in support of clinical research studies.

Responsibilities

  • Prepare each study specific protocol, informed consent form, HIPAA authorization and other related documents for review by the IRB.
  • Supports initial regulatory submission documents for IRB and sponsors to ensure site meets regulatory readiness metrics with a focus on expedited study start up
  • Ensures regulatory submissions are done in a timely manner as to not delay study start up

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