Senior Clinical Research Coordinator
CurrentRelevant Experience- Supervise all aspects of clinical research activities for studies in various phases- Function as coordinator for research compliance- Mentor and instruct research staff on ICH, GCP, federal regulations and protocol specific procedures- Prepare and process all documents needed to initiate a study for sponsor submission (e.g., FDA Forms 1572, CVs, medical licenses, IRB applications, etc.).- Review study proceedings and timelines, inc/exc criteria, confidentiality and privacy protections- Create all necessary source documents according to the eCRF’s given for each study.- Conduct and/or participate in the informed consent process, - Ensure clinical aspects of study are carried out with strict adhesion to protocol specific and Good Clinical Practice (GCP) guidelines- Create source documents for data capture per study protocol and manual of procedures- Coordinate monitor site visits and assisting with preparation of site visit documentation- Maintain research personnel CVs and training materials per protocol- Responsible for hiring, scheduling, and managing personnel in three offices. Computer Usage - Used computer-based programs to update data and test information. - Utilized windows-based computer programs to input and track data (such as PowerPoint, Excel, Word, etc.) - Entered applications into statewide database system. Employment History2015 – Present Clinical Research Coordinator TEXAS RETINA ASSOCIATES, Fort Worth, TX2013 – 2015 Ophthalmic Asst TEXAS RETINA ASSOCIATES, Fort Worth, TX2013 – 2011 Massage Therapist NOYES FAMILY CLINIC/ERICA’s MEDISPA2009 – 2011 Ophthalmic Asst ATLANTIC RETINA ASSOCIATESEducationAAS in Electronic Communications - ROSE STATE COLLEGE, Midwest City, OKUndergraduate studies in Mathematics and Education – WorWic community College, Salisbury, MD Mathematic and Education BA – Salisbury State University, Salisbury, MD
