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• Ensures all staff adheres to professional standards and SOPs established for clinical research and help with the development of new SOPs as appropriate• Oversees process implementation and ensures uniformity and accuracy• Provides back-up support and regulatory assistance as needed for team members• Assists with the oversight of the overall trial menu• Establishes and maintains a document management system for regulatory paper and electronic files• Provides oversight and assistance with initial review and triage of IND Safety Reports as delegated by the Principal Investigator. Administer support with processing those Safety Notifications that meet the IRB reportable criteria• Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks. • Creates and modifies Informed Consent Forms in compliance with IRB policy and HIPAA• Organizes and coordinates IRB documentation for trials• Assists any internal or external audit team with any regulatory related issues• Attends conference calls and monthly staff meetings as appropriate• Assists sites and team members with resolving any outstanding Regulatory items noted on monitor follow-up letters

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• Organize and coordinate IRB documentation for trials• Oversee all regulatory related tasks for Phase I and Phase 2/3 Oncology studies that are conducted at assigned strategic site locations, including the creation and completion of all IRB submissions• Ensure all continuing review submissions are completed in a timely manner in order to prevent IRB study expirations• Provide initial review and triage of IND Safety Reports as delegated by the Principal Investigator, and perform subsequent processing of those Safety Notifications that meet the IRB reportable criteria• Assist any internal or external audit team with any regulatory related issues• Apprise Regulatory Affairs Manager and Network Management, when applicable, of all study and site-specific regulatory issues for guidance and follow through• Provide assistance to any internal or external audit team in resolving any regulatory related issues.• Archive study specific regulatory documentation and correspondence• Attend network meetings, conference calls and bi-weekly staff meetings as appropriate• Practice and adhere to the “Code of Conduct” philosophy and “Mission and Value Statement”

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• Organize and coordinate IRB documentation for trials• Oversee all regulatory related tasks for Phase I and Phase 2/3 Oncology studies that are conducted at assigned strategic site locations, including the creation and completion of all IRB submissions• Ensure all continuing review submissions are completed in a timely manner in order to prevent IRB study expirations• Provide initial review and triage of IND Safety Reports as delegated by the Principal Investigator, and perform subsequent processing of those Safety Notifications that meet the IRB reportable criteria• Assist any internal or external audit team with any regulatory related issues• Apprise Regulatory Affairs Manager and Network Management, when applicable, of all study and site-specific regulatory issues for guidance and follow through• Provide assistance to any internal or external audit team in resolving any regulatory related issues.• Archive study specific regulatory documentation and correspondence• Attend network meetings, conference calls and bi-weekly staff meetings as appropriate• Practice and adhere to the “Code of Conduct” philosophy and “Mission and Value Statement”

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.• Ran queries for monthly IRB submissions.• Generated IRB submissions of IND Safety Reports and Investigator Brochures including event summaries for cover letter, compilation of individual submissions, and preparation of multiple copies for submission and filing.• Established and maintained a document management system for regulatory paper and electronic files• Archived study specific regulatory documentation and correspondence.• Interacted with on-site monitors and responded to queries from pharmaceutical company and study monitors regarding Investigator Brochure status and submissions.• Worked with Network Management team, study managers and regulatory personnel to achieve goals for quality assurance and compliance.• Attended Regulatory staff meetings and weekly Cardiology Program Development meetings.• Maintained FDA and GCP required regulatory documentation for individual sites, studies, sponsors and other networks. Ensured all regulatory documentation was compliant with local Standard Operating Procedures (SOP’s) for format and content.• Organized and coordinated IRB documentation for trials.• Assisted any internal or external audit team with any regulatory related issues.

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.• Submitted expense reports for research nurses, couriers, directors, and other employees from various departments in a timely manner• Created agendas, attended meetings, and took minutes as needed.• Created and updated reports on a weekly, monthly, and annual basis.• Booked travel reservations for various managers and their direct reports.

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 responsibilities of Seaboard's administrative staff either by completing the tasks or delegating duties to the Administrative Assistants. I was also the executive assistant to Seaboard's Chief Operating Officer and was in charge of invoicing, accounting, and payroll. I provided support to the Project Managers by updating and organizing vital information on a daily basis, and supplied them with the data in a timely manner in order to ensure the successful placement of physicians. I continued to work with various hospitals and group practices and identified qualified physicians to fill their openings. I spoke with physicians who were or who would be searching for a new position and obtained a clear understanding of their ideal practice opportunity on a personal and professional basis. After researching positions and communities, I presented to the physician only those opportunities that fit the guidelines they had laid out for me. Once a physician had selected an opportunity to pursue, I established and accelerated the interview process, virtually working as an agent for that physician.

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 various hospitals and group practices and identified qualified physicians to fill their openings. I spoke with physicians who were or who would be searching for a new position and obtained a clear understanding of their ideal practice opportunity on a personal and professional basis. After researching positions and communities, I presented to the physician only those opportunities that fit the guidelines they had laid out for me. Once a physician had selected an opportunity to pursue, I established and accelerated the interview process, virtually working as an agent for that physician.

Bachelors, Journalism

Journalism