- Quality Assurance Manager
Dr. Melissa Vinson is a psychotherapist and former Psychology professor with more than 14 years of clinical experience in the treatment of various psychological disorders. She has worked in a variety of settings including nonprofit organizations, private practice, academic institutions, and inpatient hospitals. She has also developed and implemented wellness programs, college curriculum and certification program curriculum throughout her career.
Dr. Vinson has been working directly with biopharmaceutical companies for over 5 years and is a former Clinical Rater in Phase I – Phase IV trials, Clinical Rater Supervisor and Sub-Investigator at Segal Trials. She has been certified on almost every CNS rating scale by every major rating company which enhances her knowledge of quality standards relative to clinical research and inter-rater reliability. She is well versed in research, State and Federal regulations, standards and guidelines.
While working at an inpatient hospital for a year, Dr. Vinson oversaw Quality Control measures and audited patient files to ensure compliance with JCAHO standards. Her experience as a Clinical Rater combined with her past involvement with Quality Control created a unique expertise to aid in monitoring research trials from a clinical perspective. Dr. Vinson is now responsible for all Quality Assurance functions of the organization which encompasses numerous departments and Phase I- Phase IV trials in both inpatient and outpatient settings. Taking a risk-based approach to monitoring, she actively leads activities in the areas of Internal Quality Audits, Institutional Review Board Audits, Sponsor Audits, FDA Audits and CAPA development and implementation. Dr. Vinson also develops and maintains GCP/ICH compliance processes, creates and updates current SOPs while auditing accordance to them, conducts customized coaching and trainings sessions based on QA findings, and coordinates with the Regulatory Department, Clinical Operations, and Associate Medical Director to address audit practices, inquiries and QA results.