Daphne Hubbard Email & Phone Number

Nashville Metropolitan Area

United States

Nashville TN

• Work closely with sites, team members, management, department director and or primary investigators to ensure compliance, preparing for audit activities, study start up and maintenance, meeting strict deadlines.
• Establishes and maintains a document management system for regulatory paper and electronic files, organizing and coordinating IRB documentation for trials.Attends sponsor network meetings, conference calls and monthly.
• Provide initial review and triage of IND Safety Reports as appropriate.
• Modifies and or develops informed consent forms and updates and manages protocol and consent form modifications or amendments in compliance with IRB policy and HIPPA.
• Maintains FDA and GCP required regulatory documentation for individual sites, study sponsors and/or other networks.
• Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content.

Nashville TN

• Manage electronic filing of IND Safety Reports. Assist in processing Safety Notifications under supervision of Regulatory Affairs Specialist.
• Generate IRB submissions of Investigator Brochures, event summaries for cover letter, compilation of submissions.
• Interact with onsite monitors and respond to queries from pharmaceutical company and study monitors regarding Investigator Brochure status and submissions.
• Maintain document management system for regulatory paper and electronic files and archival.
• Assists internal or external audit team with any regulatory related issues.
• Provide administrative support to Regulatory Affairs Specialist as necessary.