Tabitha Artz Email & Phone Number

Nashville, Tennessee, United States

Greater Nashville Area, TN

Nashville, TN

Nashville, TN

• Leads a team of Regulatory Affairs Specialists and Document Control Specialists
• Interviews prospective candidates for Document Control Specialist, Regulatory Affairs Specialist, and Lead Regulatory Affairs Specialist positions
• Communicates and escalates unresolved issues at the appropriate time to the appropriate level of management; Keeps management abreast of issues and progress on all assigned projects and the projects of team members
• Responsible for training, educating and mentoring Regulatory Affairs Specialists and Document Control Specialist
• Leads weekly site teleconferences and weekly Phase I Regulatory team meetings
• Initiates improvements, tools, processes, and forms to enhance the efficiency and the quality of work in the Regulatory department

Nashville, TN

• Establish and maintain solid relationships with site staff and physicians, sponsors and CRO’s, IRB members, and fellow SCRI employees and leadership teams
• Establish and maintain a document management systems for regulatory paper and electronic files
• Maintain FDA and GCP required regulatory documentation for individual sites, studies, sponsors and other networks.
• Ensure all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content
• Maintain updated investigator credentials and lab credentials for network participants and other critical documentation ensuring compliance
• Create, modify, and develop Informed Consent Forms and update and manage protocol and consent form modifications or amendments in compliance with IRB policy and HIPAA

Nashville, TN

• Establish and maintain solid relationships with site staff and physicians, sponsors and CRO’s, IRB members, and fellow SCRI employees and leadership teams
• Establish and maintain a document management systems for regulatory paper and electronic files
• Maintain FDA and GCP required regulatory documentation for individual sites, studies, sponsors and other networks.
• Ensure all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content
• Maintain updated investigator credentials and lab credentials for network participants and other critical documentation ensuring compliance
• Create, modify, and develop Informed Consent Forms and update and manage protocol and consent form modifications or amendments in compliance with IRB policy and HIPAA

Nashville, TN

• Processed clinical staff protocol training
• Created CVs for TN Oncology and Cardiology clinical staff members
• Ensured credentials on file for clinical staff and labs were current and obtained updated credentials as needed
• Served as the contact for Non-Oncology requests
• Assisted the Lead Regulatory Affairs Specialist for Cardiology and provided coverage in his absence as needed
• Oversaw the process of obtaining physician signatures as required.

Nashville, TN

• Provided administrative support including typing, composing, proofreading correspondence, indexing and filing documents
• Maintained timesheets and expense reports
• Scheduled and coordinated meetings, appointments, and calendars for directors
• Ensured adequacy of office supplies and equipment
• Processed clinical staff protocol training
• Sent reconsents to patients via certified mail and updated tracker with status.

Nashville, TN

Seaboard Health Care Search is a national physician placement firm based in Nashville, TN, which is the corporate home to 80 percent of the for profit hospital systems in the United States. Seaboard is retained by and contracted to corporations that own or operate over 2000 hospitals across the United States. As the Administrative Manager, I oversaw the.

Nashville, TN

Seaboard Health Care Search is a national physician placement firm based in Nashville, TN, which is the corporate home to 80 percent of the for profit hospital systems in the United States. Seaboard is retained by and contracted to corporations that own or operate over 2000 hospitals across the United States. As a Senior Project Manager, I worked with.

Bachelors, Journalism

Journalism