Tia Watlington

Experience

1. Clinical Research Associate

   Allucent

   May 2022 — Present

   Ensure that Investigators are conducting clinical trials in accordance with international Regulatory and Ethical guidelines for Good Clinical Practices (GCP) and International Conference on Harmonization (ICH). • Perform and coordinate all aspects of the clinical monitoring and site management process in accordance with ICH, GCP, FDA regulations, local regulations, and POI Standard Operating Procedures (SOPs). • May assist the Regulatory Affairs Department in the preparation, compilation, submission and maintenance of regulatory documentation required by international regulatory agencies for clinical trials and marketing applications. • Perform Site Evaluation, Initiation, Interim monitoring and Close-out Visits at Investigator Sites for all clinical study phases, as well as attend and assist in site audits for assigned studies. • Provide responses to corrective action plans from internal Clinical Quality Assurance audits. • Perform monitoring responsibilities to support sponsor and investigator compliance with applicable country regulatory requirements, ICH/GCP guidelines, and POI\'s SOPs.• Collect and review regulatory documents as required. • Prepare site visit reports and contact reports. • Participate in the start-up process including reviewing protocol, CRFs, Informed Consent Forms and developing study related documents. • Resolve site issues, including site recruitment challenges and determine status for IP shipment • Contribute to effective project management by proactively and positively supporting the study team meeting study timelines

Education

• University of Mississippi School of Law

  Doctor of Law (JD), Law

  1998 — 2001

• North Carolina Central University

  Bachelor of Arts, History

  1993 — 1997

Skills

• Program Management
• Research
• Mediation
• Social Media
• Clinical Trials
• Html
• Management Consulting
• Event Management
• English
• Event Planning
• Training
• Negotiation
• Budgets
• Microsoft Office
• Sales
• Community Outreach
• Courts
• Microsoft Powerpoint
• Clinical Research
• Lexisnexis
• Nonprofits
• CRO
• Customer Service
• Outlook
• Social Networking
• Contract Negotiation
• Strategy
• Coaching
• Legal Research
• Social Media Marketing
• Analysis
• Microsoft Excel
• Powerpoint
• Photoshop
• Leadership
• Strategic Planning
• Pharmaceutical Industry
• Leadership Development
• Clinical Data Management
• Public Speaking