Regulatory Office

The Regulatory Office was created to enhance regulatory compliance in accordance with internal and external guidelines and assist investigators and research staff in the preparation and submissioin of study related regulatory documents for human subject research at Scott & White. Prior to study initiation and throughout the course of the study, the Regulatory Specialist will provide administrative support by ensuring the completion and proper filing of appropriate IRB submissions and required regulatory documentation to all external entities. The Regulatory Specialists work in partnership with the Research Coordinators in order to obtain this goal. The staff is currently comprised of a Research Manager and three Regulatory Specialists with experience in the submission of required documentation to Sponsors, Clinical Research Organizations (CRO), as well as other external entities and the Institutional Review Board (IRB).

Pre-Award Phase

The Regulatory Specialist will attend any initial study meetings and communicate with the Investigators, Research Coordinators, Sponsor, CRO and the IRB. The Regulatory Specialist will ensure proper completion of all regulatory documents for submission and approval by all external entities.

Submission Phase

The Regulatory Specialist will complete all required internal regulatory documents for submission to the IRB. The Regulatory Specialist will communicate with the IRB to obtain approval of the research study and notify all members of the research staff that this approval has been obtained.

Post-Award Phase

The Regulatory Specialists are responsible for the submission of all administrative study updates to the IRB. These changes would include but are not limited to the following: Protocol Amendments, Informed Consent Revisions (ICF), External Adverse Events (MedWatch), specific Key Study Personnel changes and Monitor Reports.

Mail Phone Fax E-mail
Industry Contracts Office
Brindley Circles, 5th floor
2401 South 31st Street
Temple, TX 76508-0001
 888-883-3675  254-724-5886 Send an e-mail

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