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 staff meetings as appropriate.• 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.• Comprise essential study specific regulatory documentation and correspondence for paper and eTMF studies.• Participated in educational activities and programs.• Maintained strictest confidentiality.

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.