Tabitha Kelly
Clinical Research Professional
- Role
- Clinical Documentation Specialist at Viatris
- Location
- Fayetteville, NC, US
- LinkedIn followers
- 500 followers
About Tabitha Kelly
Tabitha Kelly | Health Coach | Nutritionist | Clinical Research Pro Passionate Health Coach skilled in nutrition, exercise, and wellness strategies. Expertise in clinical research coordination and senior-level tech support. Empowering individuals of all ages, including older adults, to embrace healthier lifestyles. Certified in health coaching and nutrition. Strong communication and coaching abilities. Seeking opportunities in healthcare management, tech, and marketing. Let\'s connect and ignite positive change together!
Experience
Clinical Documentation Specialist
Feb 2024 — Present · Fayetteville, NC, US
Job Title: Clinical Trial Documentation SpecialistJob Description- Manage and maintain all documentation related to clinical trials, ensuring accuracy, completeness, and compliance with regulatory requirements- Create, organize, and maintain trial master files (TMF) for each clinical trial, including essential documents, investigator files, and regulatory documents- Review and analyze clinical trial protocols, informed consent forms, and other trial-related documents to ensure alignment with regulatory guidelines and study objectives- Collaborate with cross-functional teams, including clinical research associates, data managers, and statisticians, to ensure proper documentation and data collection throughout the trial- Assist in the development and implementation of standard operating procedures (SOPs) for documentation management and compliance with Good Clinical Practice (GCP) guidelines- Conduct regular quality control checks on trial documentation to identify and resolve any inconsistencies, errors, or discrepancies- Prepare and maintain documentation for regulatory submissions, including study protocols, amendments, and safety reports- Coordinate and support internal and external audits and inspections, ensuring all required documentation is readily available and compliant- Stay updated on industry regulations and best practices related to clinical trial documentation and contribute to process improvements to enhance efficiency and compliance- Provide training and support to team members on proper documentation practices, ensuring adherence to regulatory requirements.
Education
Sonoran University of Health Sciences
Master of Science - MS
University of Phoenix
Associate of Arts - AA
Texas A&M University
Certification
University of Phoenix
Bachelor of Applied Science - BASc
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